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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:
February 2, 1981 to February 9, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
Deviations:
not specified
Principles of method if other than guideline:
Guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: FAT 20063/D TE
Lot: BS-BOP 01-15
Appearance: Dark blue powder
Specific details on test material used for the study:
- Physical appearance: blue powder
- Batch No.: WS 42065.02

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages numbered by ear tags, were kept at a constant room temperature of 22 ± 2°C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. The animals received, ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Shaved intact and abraded skin
Vehicle:
other: polyethylene glycol (PAG 400) + saline (70 : 30 parts)
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
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 with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden 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. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.35
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.35
Max. score:
4
Reversibility:
fully reversible within: 72 h
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 eryhema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Any other information on results incl. tables

Calculation of the primary skin irritation index:

Time after exposure (h)

Erythema

Edema

Intact skin

Abraded skin

Intact skin

Abraded skin

24

0.7

1.3

0.7

1.3

72

0

0

0

0

Total

0.7

1.3

0.7

1.3

primary irritation index = 4.0 : 4 = 1.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance can be considered as not skin irritating.
Executive summary:

The skin irritation potential of the test substance was evaluated in a study conducted according to the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. 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 with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5x2.5 cm laden 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. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. The scores after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema based on the correlation existing. The erythema and edema observed at 24 hours observation was found to have reversed at 72 hour observation. The primary irritation index was calculated to be 1.0. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP [Regulation (EC) No. 1272/2008]. Hence, the substance can be considered as not skin irritating.