Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conducted according to OECD Guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1982
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: aqueous solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Weight at study initiation: 2.0 - 2-3 kg

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
SCORING SYSTEM:
Erythema/eschar formation as well as edema formation were scored according to a 4-graded scoring system (0-3), respectively.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
2.55
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
1.72
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
During the observation period, scar formation and detachments of skin as well as hardened skin were observed. Erythema formation had not fully disappeared in all animals at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU