Registration Dossier

Administrative data

Description of key information

FAT 40554 is considered as non-irritant on skin and eye.

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:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
None
Reference:
Composition 1
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
yes
Test material information:
Composition 1
Test system:
other: dermal application
Source species:
rabbit
Source strain:
New Zealand White
Details on animal used as source of test system:
TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Justification for test system used:
None
Vehicle:
water
Details on test system:
None
Amount/concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 10gm mixed with 10ml water- Concentration (if solution): 0.75 mlVEHICLE- Amount(s) applied (volume or weight with unit): 10ml water
Duration of treatment / exposure:
72 hours
Duration of post-treatment incubation (if applicable):
None
Number of replicates:
None
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: none
Controls:
yes
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions of erythema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize.
Number of animals:
3
Details on study design:
None
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
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 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24,48 and 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24,48 and 72h
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:
No reactions were observed in any rabbits during observation period.
Other effects:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritation potential of the material was found to be 0, and therefore classified as non irritating.
Executive summary:

The aim of this study was to determine the potential of FAT 40554 to induce irritation to rabbits skin. The study was carried out according to GLP methodology and OECD Guideline 404; 92/69/EEC, B.4.

One half of the test material was spread on the 1 inch square lint patch and applied to the intact skin of 3 rabbits with an occlusive tape for 4 hours.

At the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove any remaining material by absorbent cotton dipped in acetone.

Skin reactions of erhthema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize. The evaluation of irritation potency of the test material was performed by using primary irritation score.

No skin reactions such as erythema and edema were observed in any rabbits during the observation period. primary irritation score was 0. Therefore, the irritation potential of the material was judged to be negative.

According to the EEC classification of the results obtained 0.5 to 72 hours after removing the bandages FAT 40554 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:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
None
Reference:
Composition 1
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
yes
Test material information:
Composition 1
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:
None
Vehicle:
not specified
Controls:
other: other eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
3 days
Observation period (in vivo):
1, 24, 48 and 72 hours
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
3 (2 males & 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): remain unwashed- Time after start of exposure: 1, 24, 48 and 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: over all at 24,48 and 72 hours
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(means score 2)
Time point:
other: over all at 24,48 and 72 hours
Score:
0.67
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
means score 3
Time point:
other: over all at 24,48 and 72 hours
Score:
0.33
Irritation parameter:
conjunctivae score
Max. score:
2
Remarks on result:
other: Max. duration: 48 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: over all at 24,48 and 72 hours
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: over all at 24,48 and 72 hours
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: over all at 24,48 and 72 hours
Score:
0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 24 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 hours
Score:
0.67
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.67
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 48 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 hours
Score:
0.33
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 24 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 3 days.
Other effects:
None

None

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritation potential of the test material was judged to be mild, and therefore classified as non irritant.
Executive summary:

The purpose of this study was to determine the eye irritating potency of FAT 40554

The study was performed according to GLP methodology and OECD guideline 405; 92/69/EEC, B.5.

3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 40554 was placed into the conjunctival sac of the left 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 article. The right 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, and 72 hours after the instillation of FAT 40554 according to the OECD scoring system.

FAT 40554 is considered to be non-irritant to the eyes rabbits.

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

Additional information

Skin:

The aim of this study was to determine the potential of FAT 40554 to induce irritation to rabbits skin. The study was carried out according to GLP methodology and OECD Guideline 404; 92/69/EEC, B.4.

One half of the test material was spread on the 1 inch square lint patch and applied to the intact skin of 3 rabbits with an occlusive tape for 4 hours.

At the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove any remaining material by absorbent cotton dipped in acetone.

Skin reactions of erhthema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize. The evaluation of irritation potency of the test material was performed by using primary irritation score.

No skin reactions such as erythema and edema were observed in any rabbits during the observation period. primary irritation score was 0. Therefore, the irritation potential of the material was judged to be negative.

According to the EEC classification of the results obtained 0.5 to 72 hours after removing the bandages FAT 40554 can be classified as non-irritant in albino rabbits.

Eye:

The purpose of this study was to determine the eye irritating potency of FAT 40554. The study was performed according to GLP methodology and OECD guideline 405; 92/69/EEC, B.5.

3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 40554 was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40554 according to the OECD scoring system.

The test material induced slight congestion in iris, slight redness and very slight chemosis in conjuctiva in all rabbits one hour after application. At 24 hours after application, very slight opacity in cornea and slight to moderate redness in conjuctiva in all rabbits, very slight chemosis and moderate to severe discharge in conjuctiva in 2 rabbits.

These reactions disappeared in all rabbits after 72 hours of application. The maximum mean total of these irritation reactions calculated was 15.6 at 24 hours of post-application.

FAT 40554 is considered to be non-irritant to the eyes rabbits.


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

Justification for selection of eye irritation endpoint:
Non GLP guideline study

Justification for classification or non-classification

Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).