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Description of key information

FAT 20202 is to be considered as a non-irritant to the skin and eye 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:
supporting study
Study period:
24 February, 1987 to 17 March, 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 404 (Acute Dermal 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 20202/D
Batch No.: EN 66341.62
Contents of active ingredients: 27.5 %
Physical properties:liquid, miscible with water, pH: 6.6 (lg/1 water)
Storage conditions: room temperature
Validity: December 1987
Safety precautions: gloves and face masks
Test material received: January 16, 1987
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks old
- Weight at study initiation: 2240 to 2620 g
- Housing: metal cages identified with individually numbered ear tags.
- Diet: ad libitum standard rabbit pellet - Nafag
- Water: fresh water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C,
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day.

IN LIFE PHASE: Experiment start date: 24 February, 1987; Experiment end date: 27th February 1987
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
A gauze patch (20 cm) bearing 0.5 ml of the test substance was applied to the flank.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: An area of at least 6 cm was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (2.0 cm²) bearing 0.5 ml of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank.

- Type of wrap if used: The patches were loosely covered with an aluminum foil (3.6 cm²)

- Time after start of exposure: 4 hpurs

OBSERVATION TIME POINTS
The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches


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

Erythema and eschar

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Total possible erythema score 4
Edema
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Total possible edema score 4
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
Reversibility:
not specified
Irritant / corrosive response data:
The application site was red stained (substance-related) up to 24 hours after the application; therefore the evaluation of a possible erythema formation was impeded.
Because no erythema reactions were observed at 48 to 72 hrs and no edema reactions at 24 to 72 hrs after removing the bandages, the test
was ended after the 72 hours evaluation.
Other effects:
None

Scoring tables

Erythema 

 Animal no./Time  130/M  131/M  132/M
 CF/TF   CF/TF  CF/TF 
1 hr.  0/*   0/*  0/* 
24 hr.  0/*  0/*   0/*
48 hr.  0/0  0/0  0/0 
72 hr.  0/0  0/0  0/0 
 Mean 24 - 72 hrs  0/0  0/0   0/0

The application site was red stained (substance-related, * in tabel) up to 24 hours after the application; therefore the evaluation of a possible erythema formation was impeded.

Edema Score

Animal no./Time  130/M  131/M  132/M
 CF/TF   CF/TF  CF/TF 
1 hr.  0/0   0/0  0/0
24 hr.  0/0  0/0  0/0
48 hr.  0/0  0/0  0/0 
72 hr.  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

* = red-staining (substance-related)

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20202/D is to be considered as a non-irritant to the skin of rabbits.
Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20202/D, on the skin of the rabbits. An area of at least 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (2.0 cm²) bearing 0.5 ml of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (3.6 cm² ) and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The application site was red stained up to 24 hours after the application; therefore the evaluation of a possible erythema formation was impeded. Because no erythema reactions were observed at 48 to 72 hrs and no edema reactions at 24 to 72 hrs after removing the bandages, the test was ended after the 72 hours evaluation. According to the EC classification of the results obtained, FAT 20202/D can be classified as non-irritant in albino rabbits.

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:
supporting study
Study period:
Experiment start date 10th March, 1987: Experiment end date 20th March 1987: Reported date: 31st March, 1987.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according 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 20202/D
Batch No.: EN 66341.62
Contents of active ingredients : 27.5 %
Physical properties: liquid, miscible with water, pH: 6.6 (lg/1 water)
Storage conditions: room temperature
Validity: December 1987
Safety precautions: gloves and face masks
Test material received: January 16, 1987
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks old
- Weight at study initiation: 2260 to 2870 g
- Housing: metal cages,identified with individually numbered ear tags.
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum fresh water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours light cycle day

IN LIFE PHASE: Experiment start date: 10 March, 1987; Experiment end date: 20 March, 1987

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
10 days
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
0.1 ml of FAT 20202/D was placed into the conjunctival sac of the right eye of each animal, 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 left eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, 72 hours, 7 and 10 days after the instillation of FAT 20202/D according to the OECD scoring system (Appendix 1). A slit-lamp was used to facilitate the
evaluation. The irritant/corrosive potency of FAT 20202/D was classified according to the EEC commission directive No. 83/467, 1983.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritant / corrosive response data:
The treated eyes were blue - stained (substance-related) one hour after the application; therefore, the evaluation of a possible redness of the conjunctiva was impeded. Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 10 days to determine the reversibility of the eye reactions.
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20202/D is considered to be a non-irritant to the eyes.
Executive summary:

In a study performed to determine the eye irritation potential of FAT 20202/D, test substance was instilled in the eyes of 3 male rabbits and observations for irritation were recorded till 10 days. Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 10 days to determine the reversibility of the eye reactions. The mean scores obtained were 1, 0.8, 2 and 1.1 for corneal opacity, iris, conjunctival redness and chemosis respectively. According to the EC classification of the results obtained 24 to 72 hours after instillation FAT 20202/D can be classified as non-irritant to albino rabbit's eye. The eye reactions observed were reversible until the end of the observation period on day 10. FAT 20202/D is considered to be a non-irritant to the eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:


A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20202/B (ca. 71.3 % a.i.), on the skin of the rabbits according to the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.6 rabbits (3 males and 3 females), New Zealand White breed, were shaved on the whole back and flanks before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was laden with 0.5 g of the test substance and immediately applied to the prepared skin. The patch was covered with an impermeable material, which was fixed to the body with adhesive tape.The gauze patches were removed 24 hours after the application.The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 hours for the intact skin. Therefore, FAT 20202/B is to be considered as a non-irritant to the skin of rabbits.


In a study conducted according OECD Guideline 404 to assess the skin irritation of FAT 20202/D (ca. 27.5 % a.i.) on the skin of the rabbits, the application site was red stained up to 24 hours after the application; therefore, the evaluation of a possible erythema formation was impeded. Because no erythema reactions were observed at 48 to 72 hrs and no edema reactions at 24 to 72 hrs after removing the bandages, the test was ended after the 72 hours evaluation. According to the EC classification of the results obtained, FAT 20202/D can be classified as non-irritant in albino rabbits.


Preparation FAT 20202/A (ca. 25 % a.i.) was found to cause no irritation when applied to intact and minimal irritation (1/6 rabbits) when applied to abraded rabbit skin. The primary irritation index was calculated as 0.05. Therefore, FAT 20202/A is to be considered as a non-irritant to the skin of rabbits.


The available skin irritation studies with Acid Red 407 indicate that it is not an skin irritant.


 


Eye:


In a study performed to determine the eye irritation potential of FAT 20202/B (ca. 71.3 % a.i.), the test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1, 2, 3, 4 and 7 days. FAT 20202/B was found to cause a minimal irritation when applied to the rabbit eye mucosa. However, according to the Regulation (EC) No. 1272/2008 (CLP), FAT 20202/B is considered to be a non-irritant to the eyes as it did not match the threshold criteria for classification.


In a study performed to determine the eye irritation potential of FAT 20202/D (ca. 27.5 % a.i.) according to OECD Guideline 405, the test substance was instilled in the eyes of 3 male rabbits and observations for irritation were recorded till 10 days. Because reactions were observed within 72 hours after instillation of the test compound, the observation period was extended to 10 days to determine the reversibility of the eye reactions. The mean scores obtained were 1, 0.8, 2 and 1.1 for corneal opacity, iris, conjunctival redness and chemosis respectively.


In a study performed to determine the eye irritation potential of FAT 20202/A (ca. 25 % a.i.), the test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 and 6 hours; 1; 2; 3 and 8 days. Preparation FAT 20202/A was found to cause minimal conjunctival reaction when applied to the rabbit eye mucosa. Hence, FAT 20202/A is considered to be a non irritant to the eyes.


The eye irritation study with FAT 20202/D (ca. 27.5 % a.i.) indicated some irritation is possible when Acid Red 407 enters the eye. However, a more purer FAT 20202/B (ca. 71.3 % a.i.) when instilled in the eyes of 6 rabbits, did not produce irritation in the eyes matching the threshold for classification as required by the Regulation (EC) No. 1272/2008. This result was also supported from the study with FAT 20202/A (ca. 25 % a.i.). Thus, taking the weight of evidence into account, Acid Red 407 is considered to be not an eye irritant.

Justification for classification or non-classification

Based on the above stated assessment, FAT 20202 is to be considered as a non-irritant to the skin and eye of rabbits, hence no classification is warranted according to CLP (Regulation (EC) No 1272/2008).