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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:
From 24 February, 1987 to 27 February, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981, by the OECD council)
Deviations:
yes
Remarks:
Occlusive testing conditions represent elevated testing conditions compared to today's standard protocols. Therefore, results need to be interpret with care.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: 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: Approx. 12 to 14 weeks
- Weight at study initiation: 2480 to 2780 g
- Housing: individually in metal cages
- Diet: Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

IN-LIFE DATES: From February 24, 1987 to February 27, 1987

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated contralateral flank of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE & APPLICATION
- An area of at least 6 cm² was shaved on both flanks of the animals approximately 24 h before treatment. A gauze patch (20 cm²) bearing 500 mg of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (36 cm² ) and held in place for 4 h by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

OBSERVATION: The animals were checked daily for systemic symptoms and mortality. The body weight was recorded at start and on Day 3 of the test.

SCORING SYSTEM: The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

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
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
FAT 40045/C induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages.
Other effects:
There were no signs of body weight variability, toxicity or mortality in any animal during the study period.

Any other information on results incl. tables

Erythema  

Animal No. 72/F

136/M

CF/TF

137/M

CF/TF

138/M

CF/TF

After 1 hr.

0/1

0/1

0/1

After 24 hrs.

0/0

0/0

0/0

After 48 hrs.

0/0

0/0

0/0

After 72 hrs.

0/0

0/0

0/0

Mean (24 – 72 hrs.)

0/0

0/0

0/0

 

Oedema

 

Animal No. 72/F

136/M

CF/TF

137/M

CF/TF

138/M

CF/TF

After 1 hr.

0/0

0/0

0/0

After 24 hrs.

0/0

0/0

0/0

After 48 hrs.

0/0

0/0

0/0

After 72 hrs.

0/0

0/0

0/0

Mean (24 – 72 hrs.)

0/0

0/0

0/0

 

CF = control flank TF = test flank M = male F = female

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was considered to be not irritating to the skin.
Executive summary:

A study was performed to assess the skin irritation potential of FAT 40045/C (of 100 % purity) in New Zealand White rabbits according to OECD Guideline 404. 500 mg of test substance was applied to a shaved skin area of 6 cm² on one flank of each animal under a 20 cm² gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 h. FAT 40045/C induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. No signs of body weight variability, toxicity or mortality were observed in any animal. Based on these findings, the test substance was considered to be not irritating to skin.