Registration Dossier
Registration Dossier
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EC number: 813-266-5 | CAS number: 45101-66-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Low concern regarding effects on fertility of 6-chlorohexyl methacrylate (6-CHMA) should be assumed based on data for similar substances belong to the category "short chain alkyl methacrylates".
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Read-across with similar substances based on information reported SIDS Dossier of " Short chain alkyl methacrylates" approved at SIAM 18 (20-23 April 2004)
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data is available regarding effects on fertility toxicity of 6-chlorohexyl methacrylate (6-CHMA). No concern regarding toxicity to fertility of 6-CHMA is expected based on the similarity with short chain alkyl methacrylates and in particular with 2-ethylhexyl methacrylate CAS 688-84-6 (see document "Read -across hypothesis and justification" in section 13 of this IUCLID dossier). In SIDS Dossier of " Short chain alkyl methacrylates" approved at SIAM 18 (20-23 April 2004) inside the specific section of 2-ethylhexyl methacrylate CAS 688-84-6 (2 -EHMA) a study conducted in 1998 according to OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) was reported: 2-EHMA was administered by oral gavage in corn oil to 10 male and 10 female rats at 0, 30, 100, 300, or 1000 mg/kg/day. Male rats were dosed for 49 days and female rats were dosed from 14 days prior to mating through Day 3 of lactation. The reproductive and developmental toxicological NOAEL is considered as 1000 mg/kg/day for males since there was no effect on copulation and fertility; 300 mg/kg/day for females since low values of the number of corpora lutea and the number of implantation sites were observed after administration at a dose of 1000 mg/kg; and 100 mg/kg/day for development of offspring since a low value of the number of neonates on Day 0 of lactation was observed after administration at a dose of 300 mg/kg.(Ref. Furuhashi et all, 1998, Combined Repeat Dose and Reproductive /Developmental Toxicity Screening Test of 2-Ethyl Hexyl Methacrylate by Oral Administration in Rats. (English summary), Nihon Bioresearch Inc. Hashima Laboratory,Unpublished report on behalf of Ministry of Health and Welfare, Japan).
Low concern regarding effects on fertility of 6-chlorohexyl methacrylate (6-CHMA) is based also on two inhalation studies reported always in SIDS Dossier of " Short chain alkyl methacrylates" approved at SIAM 18 (20-23 April 2004):
- 28-days inhalation study on rats exposed to n-Butyl Methacrylate (n-BMA CAS 97-88-1): no adverse histopathologic effects were observed in 5 male or 5 female reproductive organs of rats exposed to up to 1891 ppm (11176 mg/m3) n-BMA (Ref. Hagan et all, 1993, Butyl Methacrylate: Four-Week Vapor Inhalation Toxicity Study in Rats. Protocol 92P-143, Report No. 92R-143, unpublished report, Toxicology Department Rohm and Haas Company, Spring House, PA., USA).
- 2-years inhalation studies on rats and mice exposed to methyl methacrylate (MMA CAS 80-62-6): with up to 5000 ppm (20800mg/m3) of MMA no effects on reproductive organs were observed (Ref.NTP (US National Toxicology Program), 1986, Toxicology and Carcinogenesis Studies of Methyl Methacrylate in F344/N Rats and B6C3F1 Mice (Inhalation Studies), research Triangle Park, NTP TR 314, NIH Publication No. 87-2570, US Department of Health and Human Services, Public Health Service, National Institutes of Health).
Effects on developmental toxicity
Description of key information
Low concern regarding effects on developmental toxicity of 6-chlorohexyl methacrylate (6-CHMA) should be assumed based on data for similar substances belong to the category "short chain alkyl methacrylates".
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- Read-across with similar substances based on information reported SIDS Dossier of " Short chain alkyl methacrylates" approved at SIAM 18 (20-23 April 2004)
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data is available regarding effects on developmental toxicity of 6-chlorohexyl methacrylate (6-CHMA). No concern regarding developmental toxicity of 6-CHMA is expected based on the similarity with short chain alkyl methacrylates and in particular with 2-ethylhexyl methacrylate CAS 688-84-6 (see document "Read -across hypothesis and justification" in section 13 of this IUCLID dossier). In SIDS Dossier of " Short chain alkyl methacrylates" approved at SIAM 18 (20-23 April 2004) inside the specific section of 2-ethylhexyl methacrylate CAS 688-84-6 (2 -EHMA) a study conducted in 1998 according to OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test) was reported: 2-EHMA was administered by oral gavage in corn oil to 10 male and 10 female rats at 0, 30, 100, 300, or 1000 mg/kg/day. Male rats were dosed for 49 days and female rats were dosed from 14 days prior to mating through Day 3 of lactation.The developmental toxicological NOAEL is considered 100 mg/kg/day based on a low value of the number of neonates on Day 0 of lactation was observed after administration at a dose of 300 mg/kg.(Ref. Furuhashi et all, 1998, Combined Repeat Dose and Reproductive /Developmental Toxicity Screening Test of 2-Ethyl Hexyl Methacrylate by Oral Administration in Rats. (English summary), Nihon Bioresearch Inc. Hashima Laboratory,Unpublished report on behalf of Ministry of Health and Welfare, Japan).
In SIDS Dossier of " Short chain alkyl methacrylates" approved at SIAM 18 (20-23 April 2004) other inhalation studies on these similar substances (for example on n-Butyl Methacrylate n-BMA CAS 97-88-1 and on ethyl methacrylates CAS 97-63-2) are reported but no embryolethality or teratogenicity was observed even at concentration producing overt maternal toxicity.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), no classification is suggested for reproductive toxicity of 6-chlorohexyl methacrylate (6-CHMA) based on information available for the similar compounds short chain alkyl methacrylates and in particular with 2-ethylhexyl methacrylate CAS 688-84-6 (see document "Read -across hypothesis and justification" in section 13 of this IUCLID dossier).
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
