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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:
March 3, 1983 to March 14, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None

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:
no

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf
- Number and sex of animals used: 3 males
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2085 - 2150 g
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, No. 814 Tox, Gossau SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: minimum 4 days

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
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 males
Details on study design:
- Application of the Substance: Not less than 24 hours before treatment, on the back of experimental animal, an area was shaven of at least 6 sq cm, by means of an electrical 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 not irritating tape. The substance was moistened before application.

REMOVAL OF TEST SUBSTANCE
- Washing: not specified

Study evaluation
- Scoring of symptoms, and local reactions: After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period.
- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
- Body weight: At beginning of acclimatisation and end of test
- Mortality: daily (a.m. and p.m. on working days, once daily on weekends and holidays).

Results and discussion

In vitro

Other effects / acceptance of results:
None

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
3.3
Max. score:
8
Reversibility:
not fully reversible within: 7 days
Other effects:
The body weight development was in one animal only affected by the application of the test article.
No other reactions to treatment were recorded during the whole observation period.

Any other information on results incl. tables

Observations:

The scores obtained are presented in the below tables:

Erythema and eschar
Animal 1 hour 24 hours 48 hours 72 hours  7 days
31 2 2 2 2 1
32 2 2 2 2 2
33 1 1 1 1 1
Total 5 5 5 5 A = 20 
 Avg score 1.67 1.67 1.67 1.67  

Oedema
Animal 1 hour 24 hours 48 hours 72 hours  7 days
31 2 2 2 2 1
32 2 2 2 2 2
33 1 1 1 1 1
Total 5 5 5 5 B = 20 
  1.67 1.67 1.67 1.67  

INDEX of skin irritation : A 20 + B 20 = 40 : 12 = 3.33

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 31016/I was considered as an irritant to the skin.
Executive summary:

The irritation potential of FAT 31016/I was evaluated in a study conducted according to OECD Guideline 404.3 male rabbits were used in this study. A gauze patch with 0.5 g of the test material was applied to the prepared skin of the rabbitsfor the exposure duration of 4 hours. The reactions of the skin were appraised upon removal during an observation period of 7 days. The sum of scores read after 1, 24, 48 and 72 hours for erythema and edema were summed up and divided by 12 to get the primary irritation index, which was calculated to be 3.33.The mean individual scores for erythema as well as edema (mean of scores recorded at 24, 48 and 72 hours) for all 3 animals were 1.67 each. Hence, the criteria of "mean value of ≥ 2.3 - ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours", required for classification of the substance as irritant was not attained. However, till the end of observations (day 7), erythema as well as edema were found to be persistent. Hence taking a conservative approach, owing to the lack of details regarding the reversibility of skin reactions, the substance was concluded to be an irritant to the skin.