Registration Dossier

Administrative data

Description of key information

Skin irritation:
The substance did not reveal irritant to rabbit skin in an OECD 404 test.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed in accordance with the corresponding OECD-/EU-testing guidelines
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman ltd., The Field Station, Grimston, Aldbrough, Hull, HUll 4QE
- Weight at study initiation: 2.56-2.92 kg
- Housing: individual housing
- Diet (e.g. ad libitum): SQC Rat and Mouse Maintenance Diet No.1, Expanded, Special Diets Services Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water, free of contaminants
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24°C, single air-conditioned room
- Humidity (%): 39-63%
- Photoperiod: Fluorescent lighting, automatically controlled to give a cycle of 14 hours light (06.00 to 20.00 hr) and 10 hours darkness
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g test item moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the patches
Number of animals:
3 female rabbits
Details on study design:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clipper (Model A2, Oster, Milwaukee, Wisconsin).
A portion of test article (0.5 g moistened with water) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch. The patch was occluded and secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Welwyn Garden City, Herts.). A plastic collar was placed around the neck of each animal to prevent premature removal of the wrappings and ingestion of the test article. Four hours after application the patches were removed and the skin wiped with a disposable paper towel moistened with water to remove any test article still remaining.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation was noted in any animal during the 72 hour observation period. A primary irritation index of 0 was obtained. The test item was regarded as non-irritant to rabbit skin. No corrosive effects were noted.
Other effects:
None.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was classified as non-irritant to skin.
Executive summary:

The test was performed in 1983 as GLP-study according to OECD 404. Three albino rabbits were treated semi-occlusive with 0.5 g test item applied on a 6 cm2 patch. Observation times were 24, 48 and 72 hours after removal of the patch. Neither erythema nor oedema were observed in all animals. A primary irritation index of 0 was obtained.

Therefore, the test item is not irritating to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
GLP-study; Klimisch 1

Justification for classification or non-classification

Based on the data available the substance is not classified or labeled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP).