Registration Dossier

Administrative data

Description of key information

Skin irritation:
Not irritationg, key study with 6 albino rabbits following 24 hours occluded contact with the test material according to the procedure described in the U.S.Federal Register, 1973, Vol.38,No.187, Section 1500:41 (similar to OECD Guideline 404).
Eye irritation:
Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes.
This result is supported by publication data which confirm that the test substance is slightly irritating to non-irritating to eyes.

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:
From 8th July 1981 to 11st July 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test method is similar to OECD guideline 404. No GLP study.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised breeders whose premises have been inspected by Toxicol Laboratories
- Weight at study initiation: 2.55-2.66 Kg
- Housing: Grid bottomed galvanised metal cages
- Diet (e.g. ad libitum): ninety to ninety five grams of a commercially available pelleted rabbit diet (Product Ref.16934, Spillers Agriculture Limited) for each animal at a similar time each day
- Water (e.g. ad libitum): an automatic watering system provided a constant supply of drinking water to the cages

ENVIRONMENTAL CONDITIONS
- Temperature (°C): air -conditioned room
- Photoperiod (hrs dark / hrs light): 14 hours light/10 hours dark per day




Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0,5g aliquots of the test material were moistened with 0,5ml sterile distilled water.
Duration of treatment / exposure:
24 hours
Observation period:
One hour was allowed to permit any irritation from the adhesive tapes
24 hour observation
72 hour observation
Number of animals:
6
Details on study design:
TEST SITE
-Area shaved: 10% of the total dorsal surface area. The left flank was then lightly abraded with the point of a 25x0.6mm sterile disposable hypodermic needle.
-Area of exposure: 0.5g of the test sample was applied to each of two 2.5cm square surgical lint pads attached to "Sleek" plastic adhesive wrapping (one square with abraded skin and other square with intact skin)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritant/corrosive effects were noted
Other effects:
No general toxic effects were noted

No irritant/corrosive effects were noted

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not classify as a "primary irritant to the skin". It would be regarded as a mild irritant to the skin of the albino rabbit according to the Draize system of classification.
Executive summary:

The aim of this study was to investigate the degree of irritation produced to the abraded and intact skin of 6 albino rabbits following 24 hours occluded contact with the test material. The procedure used is that described in the U.S.Federal Register, 1973, Vol.38,No.187, Section 1500:41 (similar to OECD Guideline 404). 0.5 g of the test sample was applied to each of two 2.5cm square surgical lint pands attached to "Sleek" plastic adhesive wrapping. The duration of the exposure was 24 hours. Skin examinations were conducted at 24, 72h after patch removal. The average scores produced by the group of 6 rabbits were 0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.

The test substance is considered as non-irritating to the skin.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

Key study. Study with 6 albino rabbits following 24 hours occluded contact with the test material.

The procedure used was described in the U.S.Federal Register, 1973, Vol.38, No.187, Section 1500:41 (similar to OECD Guideline 404).

The result was as follows:

0.0 for erythema and 0.0 for oedema, giving a primary irritation score of 0.0. No reactions were observed throught the study.

Eye irritiation:

Study scientifically unjustified as the test substance is used in humans for so many years as a safely cosmetic in the area of the eyes. This result is supported by publication data which confirm that the test substance is slightly irritating to non-irritating to eyes.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Data waiving: Study scientifically unjustified.

Justification for classification or non-classification

Based on the available data, the substance is not classified.