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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
Study period:
2002-05-10 to 2002-06-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: Approximately four months
- Weight at study initiation: 1.9-2.1 kg
- Housing: Singly in cages measuring 425 mm x 600 mm x 380 mm
- Diet: Standard diet for Rabbits ssniff K-H V2333, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
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:
Four hours
Observation period:
Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions.
Number of animals:
Three males
Details on study design:
TEST SITE
- Area of exposure: 6cm2
- Type of wrap if used: The test site was covered with a gauze patch, held in contact with the skin under semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed

SCORING SYSTEM: According to OECD 404, Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2 and 3
Time point:
other: 60 minutes, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1, 2 and 3
Time point:
other: 60 minutes, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No erythema or oedema were observed at 60 minutes, 24, 48 and 72 hours
Other effects:
No effects reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the skin irritation study, conducted according to OECD TG 404, and in compliance with GLP, the test material, was reported to be not irritating to the skin of rabbits.
Executive summary:

Three Himalayan rabbits were exposed for four hours to 0.5 ml test material under semi-occlusive conditions on intact skin. The reactions of the intact skin were evaluated 60 minutes and then 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions. No skin reactions or other effects were observed at any of the time points in any of the rabbits.