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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted on a similar substance. The complete justification for the read across is attached at section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3 °C
- Humidity (%): 30-70
- Air changes (per hr): 12 hours light/day
- Photoperiod (hrs dark / hrs light): approximately 15 air changes/h

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 6 sq. cm

SCORING SYSTEM: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme (DRAIZE),

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 19, 21
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 19, 21
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal: 20
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal: 20
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation
Conclusions:
The substance showed to be not irritant and not corrosive .
Executive summary:

The skin irritation study was conducted in rabbits according to OECD guideline 404.

Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq. cm, by means of an electric clipper. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape. The substance was water moistened before application. Exposure duration was 4 hours. After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme (Draize scoring system).

Under the conditions of the present experiment the substance was found to be not irritating when applied to the rabbit skin according to the CLP Regulation (EC n. 1272/2008).