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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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate and tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
EC Number:
916-837-8
Molecular formula:
C29H16Na4ClN9O12S4
IUPAC Name:
Reaction mass of tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate and tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
None

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species and strain: The albino rabbit has been selected as being a recognized species for the conduct of acute dermal irritation studies. New Zealand White Rabbits checked for normal dermal conditions.
Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf.
Number and sex of animalis used: 3 females
Initial age: 12 - 14 weeks
Initial body weight range: 1900-2100 g
Individual identification: numbered ear tags. The cages were marked with sex, animal No., GU-Project No. and the company code of the test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20+3 °C, relative humidity 30-70 %; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were sacrificed by intravenous injection of hypnotic T61 (Hoechst).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: The back of the experimental animals was shaven with an electric clippeing (an area t 6 sq. cm).
Vehicle:
water
Controls:
yes
Amount / concentration applied:
0.5 g of the test to the skin
Duration of treatment / exposure:
Exposure duration was 4 hours.
Observation period:
1, 24, 48, 72 hours observation period.
Number of animals:
3 Females
Details on study design:
Application of the Substance:

Not less than 24 hour the back of the experimental animals was shaven with an electric clippeing. 0.5 g of the test material added to the skin.
The substance was moistened before application
Exposure duration was 4 hours.
Symptoms: daily a.m.and p.m., once daily on weekends and holidays.

Body weight: at beginning of acclimatization and end of test
Mortality: daily a.m.and p.m.,once daily on weekends and holidays

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.
The score obtained is defined as the "index of primary cutaneous irritation".

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Reversibility:
not specified
Irritant / corrosive response data:
None
Other effects:
The animals showed a normal body weight development.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40069/A is considered to be a non-irritant to the skin of rabbits.
Executive summary:

A study was performed to determine potential of FAT 40032/C to cause skin irritation in rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). 0.5 g of the test compound was applied and the exposure duration was 4 hours. No irritation reactions were seen. The animals showed a normal body weight development. Hence based on the findings of the study, it can be concluded, that FAT 40032/C is neither irritating nor corrosive when applied to the rabbit skin.