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: Guideline study with acceptable restrictions (no data on purity; occlusive testing in 6 animals for 24 hrs; missing 48 h reading, no information on environmental conditions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38 No. 187 § 1500.42
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: separately
- Diet (e.g. ad libitum): NAFAG, Gossau SG, rabbit food; ad lib.
- Water (e.g. ad libitum): unspecified; ad lib.

ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol trituration (PEG 400)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm on back or flanks
- Type of wrap if used: gauze patch covered with plastic film

REMOVAL OF TEST SUBSTANCE
not reported

SCORING SYSTEM: OECD Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 & 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 & 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information