Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study carried out prior to OECD and GLP GL. Some relevant criteria (dosing, observation times, assessment) similar to OECD GL

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US FDA Title 16, Section 1500.41
GLP compliance:
no
Remarks:
pre-guideline study

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, own breeding strain
- Strain: SPF-Albino-Himalayan, Hoe HIMK(SPFWiga)
- Housing: single cage
- Diet: ERKA 8300, ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:
other: patch covered by a neutral, impermeable PVC film + elastic bandage
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
0.5 g of the test substance placed on a square gauze patch, 2,5 x 2,5 cm of size was applied on a clipped/intact and clipped/scarified skin of the albino rabbit. The patches were fixed by an adhesive tape and additionally covered by a neutral, impermeable PVC film. The entire trunk of the animal is then wrapped with an elastic bandage. After 24 hours of exposure the patches are removed and the resulting reactions are evaluated. Readings are again made after 48 h and 72 h.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect occured
Remarks on result:
other: no effect on any single animal
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect occured
Remarks on result:
other: no effect on any single animal
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification acc. to (EC) 1272/2008: not irritating

This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
Executive summary:

The test material was tested for skin irritancy according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were examined at 24, 48, and 72 h after beginning of treatment. Mean values of the 24, 48 and 72 h readings were calculated for each animal. No effects were observed on each rabbit. The same results were obtained for scarified skin. Based on these findings the test material was judged not to be irritating to skin.