Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation:

The skin irritation potential of FAT 20077/A was evaluated in a study conducted according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six New Zealand White rabbits were exposed to the test substance on intact as well as abraded skin for 24 hours. Observations of erythema and edema were made at 24 and 72 hours.

A slight erythema and a very slight to moderate oedema was seen in 4/6 and 6/6 rabbits respectively, 24 hours after application of the compound.Very slight oedema was still present at 2/6 abraded sites at 72 hours. The reactions at intact sites were slightly less severe than at abraded sites. The scores recorded are below the threshold scores required for classification for skin irritation as given in Regulation (EC) no. 1272/2008. Hence,FAT 20077/A was considered to be not an irritant to skin as per the provisions of Regulation (EC) No. 1272/2008.

Eye irritation:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to U.S.A. Federal Hazardous substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

A dose of100 mg of the test compound was instilled into the conjunctival sac of the left eye. The test was carried out in both washed and unwashed eyes with test substance instillation. Ocular reactions were scored at 1, 6, 24, 48 and 72 h post-instillation.

A mild to moderate conjunctival reaction was noted in all treated eyes 1 hour after application. A slight reaction was present at 24 hours which slowly regressed until all eyes were normal by day 6. A transient corneal reaction consisting of slight opacity and damage to the surface epithelium was noted in one rabbit at one hour only.There was no significant difference between washed and unwashed eyes.Hence, based on the findings of the study,FAT 20077/A is considered to be not an eye irritant in the albino 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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Deviations:
yes
Remarks:
Testing was conducted on abraded and intact skin areas. Abration represents an elevated testing condition when compared to OECD guideline 404, therefore, data obtained uder abrasive conditions should not be taken into account for hazard assessment.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises of the testing laboratory
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: Males: 2.27 kg; Females: 2.07 kg
- Housing: Caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: Sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1°C
- Humidity: 50-70 %
- Photoperiod: Animals were exposed to artificial light for 10 h daily from 08.00 - 18.00 h
Type of coverage:
occlusive
Preparation of test site:
other: both abraded and intact skin areas lateral to the midline of the back
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
10 g of the test compound was mixed with 10ml. of water to make a solution of 15ml, 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24 h
Observation period:
Up to 72 h (the skin reactions were assessed at 24 and 72 h)
Number of animals:
six animals (five males and one female)
Details on study design:
TEST SITE
- 24 h prior to the dermal application, the backs of the animals were shaved over an area consisting of at least 10 % of the total body surface. Two test sites lateral to the mid line of the back were used on each animal. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
- The test substance was applied to each test site on a 2.5 cm² gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6 inch wide "Coban" self-adhesive bandage, the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

SCORING SYSTEM: Draize scoring system

Erythema and Eschar Formation
Description
No erythema 0
Slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet red) to slight eschar formation 4

Oedema Formation
Description
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area tuell defined
by definite raising) 2
Moderate oedema (raised approximately 1 mm.) 3
Severe-oedema (raised more than 1 mm. and extending beyond the area of exposure) 4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #6
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #4
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #5
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritation parameter:
edema score
Basis:
animal #6
Time point:
48 h
Remarks on result:
other: 48 h observation not reported
Irritant / corrosive response data:
A slight erythema and a very slight to moderate oedema was seen in 4/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present at 2/6 abraded sites at 72 hours. The reactions at intact sites were slightly less severe than at abraded sites. The primary irritation score was 1.1.
Other effects:
None
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20077/A was considered to be not an irritant to skin
Executive summary:

The skin irritation potential of FAT 20077/A was evaluated in a study conducted according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). Six New Zealand White rabbits were exposed to the test substance on intact as well as abraded skin for 24 hours. Observations of erythema and edema were made at 24 and 72 hours. A slight erythema and a very slight to moderate oedema was seen in 4/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present at 2/6 abraded sites at 72 hours. The reactions at intact sites were slightly less severe than at abraded sites. The scores recorded are below the threshold scores required for classification for skin irritation as given in Regulation (EC) no. 1272/2008. Hence, FAT 20077/A was considered to be not an irritant to skin as per the provisions of Regulation (EC) No. 1272/2008.

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Hazardous substances regulations- USA Federal Hazardous Substances Labelling Act Sect 191.12 (February 1965)
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises of the testing laboratory
- Age: 10-11 weeks
- Average body weight: Males: 2.27 kg; Females: 2.07 kg
- Diet: A commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: Sterile filtered water, ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 50-70 %
- Photoperiod: Animals were exposed to artificial light for 10 h daily from 08.00 - 18.00 h
Vehicle:
not specified
Controls:
other: untreated right eye
Amount / concentration applied:
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec
Observation period (in vivo):
24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary.
Number of animals or in vitro replicates:
Six animals (five males and one females)
Details on study design:
PROCEDURE:
-The test was carried out in accordance with the procedure set out in the Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
-The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test substance were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 sec. The right eye served as a control.

REMOVAL OF TEST SUBSTANCE
After 30 seconds the test substance was, as far as possible, flushed out of the eyes of three rabbits with warm water for 1 min.

SCORING SYSTEM: The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 30 seconds the compound was administered, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.
- Time after start of exposure: 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary

SCORING SYSTEM:

The eye reactions were assessed as follows:-
Score Assessment

0 Non-irritant
> 0 - 10 Minimally irritant
11-25 Slightly irritant
26-56 Moderately irritant
57 -84 Markedly irritant
> 84 Extremely irritant
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Transient changes at 1 hour
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 6d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6d
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6d
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
A mild to moderate conjunctival reaction was noted in all treated eyes 1 hour after application. A slight reaction was present at 24 hours which slowly regressed until all eyes were normal by day 6. A transient corneal reaction consisting of slight opacity and damage to the surface epithelium was noted in one rabbit at one hour only. There was no significant difference between washed and unwashed eyes.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20077/A was considered to be not an eye irritant.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to U.S.A. Federal Hazardous substances Labelling Act Sect. 191.12 (February 1965), with slight modification. A dose of 100 mg of the test compound was instilled into the conjunctival sac of the left eye. The test was carried out in both washed and unwashed eyes with test substance instillation. Ocular reactions were scored at 1, 6, 24, 48 and 72 h post-instillation. A mild to moderate conjunctival reaction was noted in all treated eyes 1 hour after application. A slight reaction was present at 24 hours which slowly regressed until all eyes were normal by day 6. A transient corneal reaction consisting of slight opacity and damage to the surface epithelium was noted in one rabbit at one hour only. There was no significant difference between washed and unwashed eyes. Hence, based on the findings of the study, FAT 20077/A is considered to be not an eye irritant in the albino rabbit.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

FAT 20077 was found to be non-irritant to skin and eyes of rabbits, hence, FAT 20077 is not classified for skin and eye irritation potential according to Regulation (EC) No. 1272/2008.