Risk Assessment Committee meeting - December 2015

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SUMMARY OF THE 35th ECHA RAC MEETING

Difference between DNEL and OEL

The Chairman presented the results of the first meeting of the Joint Working Group of RAC-Scientific Committee on Occupational Exposure Limits (SCOEL) concerning the Article 95 request to resolve the differences between the Derived No Effect Level (DNEL) and the Occupational Exposure Limit (OEL) for the aprotic solvent 1-methyl-2-pyrrolidone (NMP), which took place in Brussels on 27 October. ECHA accepted the request to invite SCOEL to set up a joint Task Force of SCOEL and RAC Members to examine and report on ways of converging their respective OEL/DNEL methodologies.

Harmonised classification and labelling (CLH)

• Medetomidine - RAC agreed to the proposal by the United Kingdom not to classify for the hazards acute dermal toxicity, skin corrosion/irritation, serious eye damage/irritation, respiratory and skin sensitisation, germ cell mutagenicity and carcinogenicity. 
• Penthiopyrad - RAC agreed to the proposal by United Kingdom not to classify for the physical hazards, for acute toxicity for all routes of exposure, specific target organ toxicity after single and after repeated exposure, skin corrosion/irritation, serious eye damage/irritation, respiratory and skin sensitisation and germ cell mutagenicity. RAC also agreed with the Dossier Submitter to classify penthiopyrad (ISO) as Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410), with M=1 for both hazards. 
• Clethodim - RAC agreed to the proposal by the Netherlands not to classify for the physical hazards, for acute dermal and inhalation toxicity, specific target organ toxicity after single exposure, 1 Following adequate scrutiny by the Rapporteur and commenting Members and taking the comments from the Public Consultation into account, selected hazard classes are proposed for agreement through a list (‘fast-track’) without further debate in Committee. 5 serious eye damage/irritation, respiratory sensitisation, germ cell mutagenicity and carcinogenicity. RAC also agreed to classify clethodim (ISO) as Acute Tox. 4 (H302) for the oral route, as Skin Sens. 1 (H317) and as Aquatic Chronic 3 (H412). 
• 2,3-epoxypropyl methacrylate - RAC agreed to the proposal by the Netherlands to classify the substance as Acute Tox. 4 (H302), Skin Corr. 1C (H314) and Eye Dam. 1 (without H318 label), and Skin Sens. 1 (H317). RAC also agreed to remove the classification for acute inhalation toxicity (Acute Tox. 4* - (H332) from Annex VI to CLP.
• Hexaflumuron - RAC agreed to the proposal by Portugal not to classify for the physical hazards, for acute toxicity for all routes of exposure, specific target organ toxicity after single exposure, skin corrosion/irritation, serious eye damage/irritation, respiratory and skin sensitisation, germ cell mutagenicity, carcinogenicity and reproductive toxicity. RAC also agreed with the Dossier Submitter to classify Hexaflumuron (ISO) as Aquatic Acute 1 and Aquatic Chronic 1, with M=1000 for the acute and M=10000 for the chronic aquatic hazard. 
• 3,3''-dicyclohexyl-1,1''-methylenebis(4,1-phenylene)diurea - RAC did not agree to the proposal by Germany to remove the classification as Aquatic Chronic 4 (H413) from Annex VI, but decided to retain this classification. 

Substances with hazard classes for agreement in plenary session        

• Anthraquinone - The Chairman reported that anthraquinone (AQ) was an industrial chemical and a pesticide and that it was mainly used in the paper/pulp industry and as an intermediate for synthesis of other chemicals, including dyestuffs. It has no existing entry in Annex VI to the CLP Regulation. The legal deadline for the adoption of an opinion is 29 July 2016. The DS (Germany) proposed to classify anthraquinone as Carc. 1B (H350). The overall evidence was considered as clearly in support of classification in category 1B and RAC agreed to classify anthraquinone as Carc. 1B; H350. 
• cadmium carbonatecadmium nitratecadmium hydroxide -  Based on the overall evidence, RAC therefore concluded on Carc. 1B (H350) for the three cadmium compounds. RAC also agreed to set an SCL of 0.01% for cadmium nitrate, because its bioavailability and carcinogenic potency was considered to be comparable to the other very (water) soluble cadmium compounds for which this SCL had been established. However, it was considered inappropriate to extrapolate estimates of potency from the very soluble cadmium compounds to the less soluble cadmium carbonate and hydroxide, despite the inherent hazards being comparable.
• 2,3-epoxypropyl methacrylate (GMA) - The Netherlands proposed to revise the existing classification and to add classification for carcinogenicity, mutagenicity and reproductive toxicity (Repr. 1B; H360F, Muta. 2; H341, Carc. 1B; H350) and for specific target organ toxicity after single exposure (STOT SE 1; H370, affected organs: respiratory tract; route of exposure: inhalation). RAC agreed with the proposal to confirm the existing minimum classification for acute oral toxicity (Acute Tox. 4; H302). It also agreed to classify GMA in category  Muta. 2 and Repr. 1B. RAC did not support the proposal to classify the substance for STOT SE 1 but recommended classification in STOT SE 3 for respiratory irritation, based on the signs of respiratory irritation in acute toxicity studies. RAC decided not to classify GMA for respiratory sensitisation.
• 3,3''-dicyclohexyl-1,1''-methylenebis(4,1-phenylene)diurea - RAC adopted the proposal to retain the classification as "Aquatic Chronic 4 (H413)" and to remove "Skin Sens. 1 (H317)".
• Zeolites, AgZn - RAC adopted the classification proposed by Sweden: Repr. 2 (H361d), Skin Irrit. 2 (H315), Eye Dam. 1 (H318), Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410), with M=100 for both hazards.
• Hexaflumuron - RAC adopted the following harmonised classification and labelling proposal: Aquatic Acute 1 (H400); M=1000 and Aquatic Chronic 1 (H410); M=10000  
• Penthiopyrad - RAC adopted the following harmonised classification and labelling proposal: Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410), with M=1 for both hazards.
• PFDAammonium nonadecafluorodecanoate - RAC adopted the following harmonised classification and labelling proposal: Carc. 2 (H351), Repr. 1B (H360Df), Lact. (H362).
• Triadimenol A - RAC adopted the following harmonised classification and labelling proposal: Acute Tox. 4 (H302), Repr. 1B (H360), Lact. (H362), Aquatic Chronic 2 (H411)
• Salicylic acid - The discussion on developmental toxicity was postponed (for RAC-36)
• MBM - RAC adopted the following harmonised classification and labelling proposal: Acute Tox. 4; H302, Acute Tox. 4; H312, Acute Tox. 4; H332, EUH071, Skin Corr. 1B; H314, Skin Sens. 1; H317, Muta. 2; H341, STOT RE 2; H373 (GI tract and respiratory tract), Carc. 1B; H350
• Reaction product of paraformaldehyde and 2-hydroxypropylamine (ratio 1:1) (HPT) (toxicity to reproduction) - RAC adopted the following harmonised classification and labelling proposal: Acute Tox. 4; H302, Acute Tox. 4; H332, Skin Corr. 1C; H314, Eye Dam. 1, Skin Sens. 1A; H317, STOT RE 2; H373 (GI tract and respiratory tract), Carc. 1B; H350, Muta 2; H341, Aquatic Chronic 2; H411, EUH071
• Medetomidine- RAC adopted the following harmonised classification and labelling proposal: Acute Tox. 2 (H300 and H330), STOT SE 1 (H370) (eyes), STOT SE 3 (H336), STOT RE 1 (H372), Aquatic Acute 1 (H400); M=1 and Aquatic Chronic 1 (H410); M=100
• Clethodim- RAC adopted the following harmonised classification and labelling proposal: Acute Tox. 4 (H302), Skin Sens. 1 (H317), Aquatic Chronic 3 (H412), EUH 066
• Reaction mass of isomers of benzotriazoles and phenols (Tinuvin 171/571)- RAC adopted the following harmonised classification and labelling proposal: Aquatic Chronic 4 (H413)

Restrictions

• Methanol - Revised draft opinion -  RAC agreed on the proposal and in the application of an assessment factor of 3 (in line with ECHA Guidance) resulting in a DNEL value of 0.088 g/kg bw.
• Octamethylcyclotetrasiloxane (D4)  Decamethylcyclopentasiloxane (D5) - The restriction dossier on D4/D5 had been submitted by UK in April 2015.  Both D4 and D5 have vPvB properties. RAC agreed with the restriction proposal to reducing emissions to the aquatic environment and that D4 and D5 shall not be placed on the market or used in concentrations equal to or greater than 0.1% by weight of each in personal care products (PCPs) that are washed off in normal use conditions. 

Conformity check

• TDFAs (polyfluorooctyl trialkoxysilanes) - The restriction on the use of TDFAsi in mixtures containing organic solvents placed on the market or used in spray products for consumers (aerosol dispensers, hand pump and trigger sprays and mixtures marketed for spray application) was presented. RAC agreed that the dossier in not in conformity due to the shortcomings in hazard assessment (the link of TDFAs to human cases is insufficient) and exposure estimations (exposure model to simulate consumer 24 exposure should be developed). SEAC will conclude on the conformity of this dossier at SEAC-29.

Authorisation

• chromium trioxide - The application for authorisation submitted by Kromatek was analysed. The authorisation was related to the use of chromium trioxide in Cr(VI) based functional plating. RAC agreed on the need for further clarification by the Applicant, including the actual exposure for different working contributing scenarios for which proper use of PPEs is required, as well as information on the training provided to workers. In addition, more details are needed on the methodology used for the submitted measurements of the environmental releases to water. 
• chromium trioxide - The application for authorisation submitted by Grohe was analysed. The authorisation was related to the use of chromium trioxide for electroplating of different types of substrates with the purpose of creating a long-lasting, high durability surface with a shiny or matte look (also called ‘functional plating with decorative character’) and for pre-treatment step in the electroplating process. RAC agreed that there is a lack of detailed information regarding the sampling methodology/protocol for the static measurements and biomonitoring data, such as number of data points to describe the exposure of each activity, measuring method and frequency, as well as location of measurements, etc. The justification for air and water release estimates is lacking and further evidence to substantiate these estimates will be requested.
• sodium chromate - The application for authorisation submitted by Dometic was analysed. The authorisation was related to the use of sodium chromate as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0.75% by weight (Cr 6+) in the cooling solution. RAC agreed to propose that the applicant should improve RMMs, in accordance with the plans they described themselves in the application. RAC also agreed to propose monitoring arrangements with immediate effect, in order to monitor and confirm the reduction of the workplace exposure.
• sodium dichromate - The application for authorisation submitted by Boliden Mineral AB was analysed. The authorisation was related to the use of sodium dichromate in copper/lead separation in concentrators handling complex sulphide ores. RAC agreed to propose additional, regular monitoring programs as already mentioned by the Applicant for the review report in order to further reduce uncertainty surrounding the exposures.
• dichloroethane -  The application for authorisation submitted by Laboratoires Expanscience was analysed. The authorisation was related to the use of 1,2-dichloroethane to process and extracting solvent in fine chemical processes. RAC proposed additional working conditions and monitoring arrangements, including monitoring campaigns, closed sampling system and further investigation of potential leakages by the Applicant. 
• chromium trioxide - The application for authorisation submitted by Lanxess was analysed. The authorisation was related to the use i) in formulation of mixtures, ii) in functional chrome plating, iii) in functional chrome plating with decorative character, iv) in surface treatment for applications in the aeronautics and aerospace industries, v) in surface treatment (except ETP) for applications in various industry sectors namely architectural, automotive, metal manufacturing and finishing, and general engineering and vi) in passivation of tin-plated steel (ETP). Among other information, RAC requested that for all uses the applicants reveal all redacted (blanked-out) data with the exception of the company names. A request to describe the RMMs and OCs across the uses ii - v will be also submitted (i.e. asking them to state how they intend to achieve their proposed maximum exposure concentration of 2 μg/m3 in case this would become a condition in any future authorisation).

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Related links:

• Source: Minutes of the 35th meeting of the ECHA Risk Assessment Committee (RAC) - December 2015
• Minutes of the 35th meeting of the ECHA Socio-Economic Analysis Committee (SEAC) - December 2015
• ECHA Committee for Risk Assessment (RAC)