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Description of key information

FAT 40032 is to be considered as a non-irritant to the skin and eyes of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
yes
Specific details on test material used for the study:
None
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).
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".
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.

None

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
no
Specific details on test material used for the study:
Test substance: FAT 40032/D
Batch No.: EN 19721.62
Contents of active ingredients: 93.7 %
Physical properties: powder, solubility in water approx. 100 g/l at 20 °C, pH 6.9
Storage conditions: room temperature
Validity: December 1991
Test material received: January 16, 1987
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 1 female rabbit, checked for normal eye conditions, weighing between 24 90 g (approx. 12-14 weeks old). The animal was housed individually in a metal cage identified with a numbered ear tag, kept at a constant room temperature of 20±3 °C, àt a relative humidity of 30-70 % and on a 12 hours light cycle day. The rabbit received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water. All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results are available at the animal supply office. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). Results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to Ciba-Geigy Ltd., as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceuticals Division, Ciba-Geigy Ltd. The body weight was recorded at start and on days 3, 7, and 14 of the test.
Amount / concentration applied:
0.1 ml (66 mg) of FAT 40032/D was placed into the conjunctival sac of the left eye of animal.
Duration of treatment / exposure:
1 second
Observation period (in vivo):
1, 24, 48, 72 hours , 7 and 14 days
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
1 Female
Details on study design:
The left eye of animal was treated with the test substance after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
The right eye remained untreated and served as a control. The animal was checked daily for systemic symptoms and mortality.


Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40032/D can be classified as non-irritant according to the EEC Directive No.83/467/1983.
Executive summary:

A study was performed to determine the eye irritation potential of FAT 40032/D in rabbits. There were some mild reactions observed in the eyes of the animals. Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 14 days to determine the reversibility of the eye reactions. Slight reddish staining of the cornea was seen, disappearing within 14 days. According to the EC classification of the results obtained 24 to 72 hours after instillation, FAT 40032/D can be classified as non-irritant to albino rabbit's eye. The eye reactions were reversible until the end of the observation period of day 14.

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin:

Skin irritation potential of Reactive Brown 11 was evaluated in three available studies. The outcome of all these studies indicated the test substance to be not a skin irritant.

In the key study carried out to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound FAT 40032/C on the skin of the rabbits according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO). The primary irritation index was found to be 0.0. Hence, it can be concluded that FAT 40032/C is neither irritating nor corrosive when applied to the rabbit skin.

Eye:

Eye irritation potential of Reactive Brown 11 was evaluated in four available studies. The outcome of all these studies indicated it to be not an eye irritant. In the key study performed to determine the eye irritation potential of FAT 40032/D on rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO) there were some mild reactions observed in the animals. Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 14 days to determine the reversibility of the eye reactions. Slight reddish staining of the cornea was seen, disappearing within 14 days. According to the EC classification of the results obtained 24 to 72 hours after instillation, FAT 40032/D can be classified as non-irritant to albino rabbit's eye.

Justification for classification or non-classification

Based on the above stated assessment, FAT 40032 is to be considered as a non-irritant to the skin and eyes according to the CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council).