Registration Dossier
Registration Dossier
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EC number: 203-441-9 | CAS number: 106-91-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Title:
- No information
- Author:
- Dow
- Year:
- 1 992
- Bibliographic source:
- The Dow Chemical Company, unpublished report (dermal sensitization) (1992)
- Title:
- No information
- Author:
- OECD
- Year:
- 1 999
- Bibliographic source:
- OECD SIDS for glycidyl methacrylate, December 1999
Materials and methods
Test guideline
- Guideline:
- other: Delayed allergy reaction test
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed prior to the guideline for the LLNA being established
Test material
- Reference substance name:
- 2,3-epoxypropyl methacrylate
- EC Number:
- 203-441-9
- EC Name:
- 2,3-epoxypropyl methacrylate
- Cas Number:
- 106-91-2
- Molecular formula:
- C7H10O3
- IUPAC Name:
- oxiran-2-ylmethyl methacrylate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- 0.4 ml of a 10% or 25% solution of glycidyl methacrylate in dipropylene glycol monomethyl ether (DPGME).
Challenge
- Concentration / amount:
- 0.4 ml of a 10% or 25% solution of glycidyl methacrylate in dipropylene glycol monomethyl ether (DPGME).
- Details on study design:
- 10 animals received three topical applications on the left side with 0.4 ml of 10 or 25 % glycidyl methacrylate in dipropylene glycol monomethyl ether (DPGME) during the three week induction phase. The animals with slight erythema on the dermal test site after the second application received the third application at lower concentration. The applications were removed after a six-hour exposure period. After a two-week rest period, the single challenge application was conducted to the right side of the animals in the same manner as the induction applications. The animals with slight erythema on the dermal test site after the third induction exposure received a 1 % solution of glycidyl methacrylate in DPGME. As positive control (10 animals), DER 331 epoxy resin in DPGME was used.
- Positive control substance(s):
- yes
- Remarks:
- DER 331 epoxy resin
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 10% and 25%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 10% and 25%. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: slight erythema.
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 10% and 25%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- slight erythema
- Remarks on result:
- other: Reading: 1st reading. Group: positive control. Dose level: 10% and 25%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: slight erythema.
Applicant's summary and conclusion
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.
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