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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A study was carried out according to OECD Guideline 404 (skin irritation) on six NZW rabbits. The test was performed in 1980 as non-GLP-study. The substance was classified as non-irritant to skin.

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:
November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline-study (non-GLP)
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: 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: Hylyne Rabbits Ltd., Commercial Rabbits, 78 Warring ton Road, Statham UK
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 2.97-3.20 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Standard Rabbit Diet, B.P. Nutrition (UK) Ltd., Stepfield, Witham, Essex
- Water (e.g. ad libitum): Tap water
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-22°C
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 14 hours artificial light
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm).
Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
6 animals
Details on study design:
Application of test article:
Twenty four hours prior to treatment, the back of each animal was clipped free of hair using veterinary clippers (Model A2, Oster,
Milwaukee, Wisconsin). The left side of the clipped area on each animal was left intact. The right side was abraded using a clipper head to penetrate the horny layer of the epidermis, but without causing bleeding or damage to the underlying dermis. Portions of the test article (0.5 ml) were applied to 1 intact and 1 abraded site on each animal and covered with patches of gauze (25 mm x 25 mm). A small plug of cotton wool weighing approximately 1 g was placed over the top of the pads to achieve uniform pressure over the whole treated surface. The pads were held in place by a strip of adhesive impermeable plaster, (Sleek, Smith and Nephew Ltd., Welwyn Garden City, Herts).
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score 1 observed in one animal after 4 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score 1 observed in two animals after 4 hours
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Two animals showed very slight erythema and one animal very slight oedema in both intact and abraded sites 4 hours after treatment. All skin reactions regressed and appeared normal at the 24 hour observation. A primary irritation index of 0.17 was obtained. The test article was classified as a mild skin irritant. P5098 did not produce a corrosive response.
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:

A study was carried out according to OECD Guideline 404 (skin irritation) on six NZW rabbits. The test was performed in 1980 as non-GLP-study. Six albino rabbits were treated semi-occlusive with 0.5 g test item applied on a 25 x 25 mm gauze covered with patches. Observation times were 24, 48 and 72 hours after removal of the patch. Slight erythema and oedema were observed in two out of six animals, resulting in a primary irritation index of 0.2. The substance was classified as non-irritant to skin.

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

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Klimisch 2 study; test design according to OECD 404 (non-GLP)

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).