Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
1990
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

Constituent 1
Chemical structure
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

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.

Categories Display