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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Treatment of 2 white rabbits (New Zealand) on the inner side of the ear for 24 hours under occlusive conditions; dose: .5 ml. Observation period: 7 days.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): nitrobenzene
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
24h, 48h and 7 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: innder side of the ear
- Type of wrap if used: plaster (no further details)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test side was washed with water and soap/vegetable oil.
- Time after start of exposure: 24 h

Results and discussion

In vivo

Results
Irritation parameter:
other: not irritant
Basis:
animal: rabit
Time point:
other: 7 days
Score:
0

Any other information on results incl. tables

No reaction was observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment