Registration Dossier
Registration Dossier
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EC number: 227-642-6 | CAS number: 5919-74-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Morphological Changes of Rabbit Skin by Application of Dentin Primer
- Author:
- Manabe A. et. al.
- Year:
- 1 990
- Bibliographic source:
- Dental Materials Journal 9 (2): 147-152, 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,3-dihydroxypropyl methacrylate
- EC Number:
- 227-642-6
- EC Name:
- 2,3-dihydroxypropyl methacrylate
- Cas Number:
- 5919-74-4
- Molecular formula:
- C7H12O4
- IUPAC Name:
- 2,3-dihydroxypropyl 2-methylprop-2-enoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 62 months
- Weight at study initiation: approx. 2 kg
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TtEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
- Concentration (if solution): 25 and 35 wt% in water
- Duration of treatment / exposure:
- twice daily for 7 days
- Observation period:
- 7 days
- Details on study design:
- 30 µL of the dentin primers was applied twice a day for 7 days to the shaved skin of white rabbits. Twenty min after the final application, 3 of the rabbits were sacrificed to examine possible pathological changes and the others were sacrificed after an additional 7 days without primer application in order to observe any recovery in cutaneous changes.
Results and discussion
In vivo
Results
- Remarks on result:
- other: no obvious changes were recognized
- Other effects:
- No morphological changes were observed in the shaved skin of rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- No morphological changes were observed in the shaved skin of rabbits after repeated application of GM solution.
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