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Description of key information

FAT 40000 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:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: 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:
other: Chbbibm: NZW (SPF)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH Postfach 1755 0·7950 Biberach a.d. Riss
- Age at study initiation: 15 weeks
- Weight at study initiation: male : 2.8 kg females: 3.2 kg
- Housing: Individually in stainless steel cages (size: 86 x 54 x 33 em) equipped with feed hoppers and drinking water bottles.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 69/92 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from FOllinsdorf, ad libitum
- Acclimation period: Five days under test conditions after veterinary examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, music during the light period.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 g of substance was applied.
Duration of treatment / exposure:
4 hours
Observation period:
None
Number of animals:
1 male
2 females
Details on study design:
None
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40000 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 40000, on the skin of the rabbits. 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water. 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 according to the OECD scoring system. The application site was yellow 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 4 8 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 40000/G 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:
key study
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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 tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Postfach 1755, D-7950 Biberach an der Riss
- Age at study initiation:15 weeks
- Weight at study initiation: male : 2.9 kg females: 2.4 - 2.8 kg
- Housing: Individually in stainless steel cages (size: 86 x 54 x 33 cm) equipped with feed
hoppers and drinking water bottles.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 69/92 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum. Results of analysis for
contaminants are included in this report.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in this report.
- Acclimation period: Five days under laboratory conditions after veterinary examination. Only animals without any visual signs of illness were used for the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3°C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark, music during the light period.
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 g of the test article
Duration of treatment / exposure:
None
Observation period (in vivo):
1, 24, 48 and 72 hours and 7 days after administration.
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
1 male
2 females
Details on study design:
None
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.9
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40000/G is considered to be non-irritant to the eyes.
Executive summary:

In a study performed to determine the eye irritation potential of FAT 40000/G, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1 hour, 24 hours, 48 hours 72 hours. On test day 1, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. FAT 40000/G 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 40000, on the skin of the rabbits.0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm-tap water. 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 according to the OECD scoring system. The application site was yellow 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 4 8 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 40000/G can be classified as non-irritant in albino rabbits.

In addition several other studies have been conducted involving different batches of the test item all proving non-irritant test results of the key study selected. Based on these data batch and production process specific effects on skin irritation can be ruled out.

Eye:

In a study performed to determine the eye irritation potential of FAT 40000/G, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1 hour, 24 hours, 48 hours 72 hours. On test day 1, 0.1 g of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower . lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control. FAT 40000/G is considered to be a non-irritant to the eyes.

In addition several other studies have been conducted involving different batches of the test item all proving non-irritant test results of the key study selected. Based on these data batch and production process specific effects on eye irritation can be ruled out.

Justification for classification or non-classification

Based on the above stated assessment, FAT 40000 is to be considered as a non-irritant to the skin and eye of rabbits, hence no classification is warranted according toCLP (Regulation (EC) No 1272/2008).