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Administrative data

Description of key information

The test substance FAT 60'253/A was found to be not irritating to the skin and eyes of rabbit.

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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation:14 weeks (male); 13 weeks (females)
- Weight at study initiation:2.4 to 2.7 kg
- Housing:Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood (RCC Ltd, Füllinsdorf) and haysticks for gnawing.
- Diet (e.g. ad libitum):Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 30/00) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis are archived at RCC Ltd, Hingen. Haysticks (QS no. 102/00) provided by Eberle Nafag AG, CH-9200 Gossau.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Hingen.
- Acclimation period:Six days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ±3
- Humidity (%):45-70
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: The test substance was moistened with bidistilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:100 cm2 (10 cm x 10 cm).
- Type of wrap if used:The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.

SCORING SYSTEM:The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test item.
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
The test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and 0 for oedema
Other effects:
COLORATION:
There was no staining of the treated skin by the test article observed. MORTALITY/CLINICAL SIGNS: No mortality and no clinical signs noted.

None

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of FAT 60'253/A was investigated by topical semiocclusive application of 0.5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.

The test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hour were therefore 0 for erythema and 0 for oedema.

The test item caused no staining of the treated skin.

No corrosive effects were noted on the treated skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to 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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Reference:
Composition 1
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation:15 weeks (male); 14 weeks (females)
- Weight at study initiation:2.8 to 3.2 kg
- Housing:Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclaved wood (02/2000, RCC Ltd, Füllinsdorf) and haysticks for gnawing.
- Diet (e.g. ad libitum):Pelleted standard Provimi Kliba 3418 rabbit maintenance diet aaf libitum (batch no. 30/00) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis are archived at RCC Ltd, Hingen.
Haysticks (QS no. 137/00 and 168/00) provided by Eberle Nafag AG, CH-9200 Gossau.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period:Six to seven days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-23.5
- Humidity (%):approximately 44-79
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours dark.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
about one second
Observation period (in vivo):
1 hr, 24 hrs, 48 hrs,72 hours, 7 days
Number of animals or in vitro replicates:
3
Details on study design:
TREATMENT
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, FAT 60'253/A was placed in the conjunctival sac of the left eye of one male 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 test item. The right eye remained untreated and served as the reference control. As no severe irritant occular lesions occured after 24 hours, the other two animals were treated in the same way as the first animal 24 hours later. The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7 days after application.
When present, corrosion and/or staining of sclera and cornea by the test item were recorded and reported. Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
No corrosion of the cornea was observed at any of the reading times.
Other effects:
COLORATION:
Yellow remnants were observed in the eye or conjunctival
sac of all animals. No coloration was noted.

BODY WEIGHTS : The body weights of all rabbits were considered to be within the normal range of variability.

None

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21 /EEC of April 27,1993), FAT 60'253/A is considered to be "not irritating" to the rabbit eye.
Executive summary:

The primary eye irritation potential of FAT 60'253/A was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.89 redness of the conjunctivae and grade 0.22 Chemosis of the conjunctivae.

No corneal and iridal effects were observed. Slight to moderate redness of the conjunctivae and/or nictitating membrane was recorded for all animals from 1 to 48 hours after treatment. The redness diminished and cleared in two animals at 72 hours and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. Moderate reddening of the sclera was observed in all animals at the 1-hour examination. The scleral redness diminished to slight at 24 hours and cleared in one animal by 48 hours and in two animals by 72 hours. A slight watery discharge was noted in one animal at the 1-hour reading.

No staining of the treated eyes by the test item was observed.

Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.

No corrosion was observed at any of the measuring intervals.

All eye reactions were clear within 7 days after treatment.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to the rabbit eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A key study was performed to evaluate the primary skin irritation potential of FAT 60'253/A by topical semiocclusive application of 0.5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.

The test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hour were therefore 0 for erythema and 0 for oedema.

The test item caused no staining of the treated skin.

No corrosive effects were noted on the treated skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to rabbit skin.

A key study was performed to evaluate the primary eye irritation potential of FAT 60'253/A by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.89 redness of the conjunctivae and grade 0.22 Chemosis of the conjunctivae.

No corneal and iridal effects were observed. Slight to moderate redness of the conjunctivae and/or nictitating membrane was recorded for all animals from 1 to 48 hours after treatment. The redness diminished and cleared in two animals at 72 hours and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. Moderate reddening of the sclera was observed in all animals at the 1-hour examination. The scleral redness diminished to slight at 24 hours and cleared in one animal by 48 hours and in two animals by 72 hours. A slight watery discharge was noted in one animal at the 1-hour reading.

No staining of the treated eyes by the test item was observed.

Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.

No corrosion was observed at any of the measuring intervals.

All eye reactions were clear within 7 days after treatment.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to the rabbit eye.


Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study

Justification for selection of eye irritation endpoint:
GLP guideline study

Justification for classification or non-classification

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to the rabbit skin and eye.