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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:
1980-03-19 and 1980-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP conform, according to Guideline of the United States Environmental Agency (EPA)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
1978
Deviations:
yes
Remarks:
duration of exposure: 24 h
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
FAT 11181/A
IUPAC Name:
FAT 11181/A
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2 to 3 kgs
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG (ad libitum)
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Photoperiod: 10 hours tight cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: propylene glycol + saline (70:30 parts)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 per sex
Details on study design:
TEST SITE
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and Immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x2.5 cm loaded with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: after a 24 hour application

SCORING SYSTEM: according to the Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/48 h/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU

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