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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:
1977
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:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
None

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult ones
- Weight at study initiation: 1.5 to 2 kgs
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C,
- Humidity (%): 55 ± 5 %
- Photoperiod: 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, with one side abraded and one site kept intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Type of wrap if used: 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.

REMOVAL OF TEST SUBSTANCE
- Washing: not specified
- Time after start of exposure: 24 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0
Max. score:
8
Reversibility:
not specified
Irritant / corrosive response data:
The primary irritation index for FAT 36080/B was calculated to be 0, indicating no potential to cause irritation when applied to intact and abraded rabbit skin.
Other effects:
No other effects reported, no signs of systemic toxicity observed.

Any other information on results incl. tables

Results:

Erythema

Animal

Intact skin

Scarified skin

24 hours

72 hours

24 hours

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

6

0

0

0

0

Oedema

Animal

Intact skin

Scarified skin

24 hours

72 hours

24 hours

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

6

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 36080/B was found to be non-irritant to the skin.
Executive summary:

The irritation potential of FAT 36080/B was evaluated in a study conducted according to the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males; 3 females) were used in this study. Gauze patches of 2.5 x 2.5 cm laden with 0.5 ml of the test material were applied to the prepared abraded and intact skin for the exposure duration of 24 hours. The reactions of the skin were appraised upon removal during an observation period of 72 hours. The scores read 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 to get the primary irritation index. The primary irritation index was calculated to be 0.0, indicating no potential to cause irritation when applied to intact and abraded rabbit skin. Hence, FAT 36080/B was considered to be non-irritant to the skin.