Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-01-07 - 1985-01-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: EEC Directive 79/831, Annex V, Part B : Methods for the determination of toxicity; 4.1.5. Acute Toxicity "Skin Irritation".
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Lot/batch No.: CH 5/1
- Stability under test conditions: stable under the conditions of use
- Other: Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
other: Erythema, edema and cumulative score
Basis:
animal: #78, #79 and #80
Time point:
other: 1h, 24h, 48h and 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Other effects:
No other effects have been observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The test article is not irritating under the test conditions.