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Description of key information

Fat 20004 is considered to be non irritant to eyes and skin 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:
Study completion date - 14 August 1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
GLP compliance:
no
Specific details on test material used for the study:
Name: FAT 20004/D
Purity: 61 %
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG Gossau SG
- Water: water ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1°C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hours light cycle day
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
Up to 7 d
Number of animals:
six animals (Three males and three females)
Details on study design:
TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.

Score for skin irritation in rabbits
Erythema and eschar formation
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 formation
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
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
animal:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
animal:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
animal:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Abraded skin
Basis:
animal:
Remarks:
mean of six animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Calculation of the primary skin irritation index:


The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.


 













































Time after exposure hmean reaction score of 6 rabbits 
erythemaedema
intact skin abraded skinintact skinabraded skin
240000
720000
subtotal0000
total0        +       0      +        0      +          0    =     0
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.
Executive summary:

A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24-hours exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.

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:
Study completion date - 14 August 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Specific details on test material used for the study:
Name: FAT 20004/D
Purity: 61 %
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: Water, ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hour light cycle
Vehicle:
not specified
Controls:
yes, concurrent no treatment
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):
The rabbits were examined for day 1, 2, 3, 4 and 7 d after application of the test.
Number of animals or in vitro replicates:
Six animals (Three males and three females)
Details on study design:
PROCEDURE:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control.

REMOVAL OF TEST SUBSTANCE: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water.

SCORING SYSTEM: The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes, respectively.

SCORING SYSTEM: Scale for scoring Ocular Lesions.
1.Cornea
(A) Opacity-degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4

(B) Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4

AxBx5 Total maximum=80

2.Iris
(A) Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Ax5 Total maximum=10

3.Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3

(B) Chemosis
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4

(C) Discharge'
- No discharge: 0
- Any amount different from normal (does not include small amounts observed" in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Score (a+b+c)x 2 Total maximum=20

TOOL USED TO ASSESS SCORE: slit lamp
Irritation parameter:
cornea opacity score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.11
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.5
Max. score:
3
Reversibility:
fully reversible within: 96 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Remarks:
Not rinsed eyes
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 96 h
Remarks on result:
no indication of irritation

  Unrinsed Eyes Rinsed Eyes
Days after Appl. Rabbit 1 (Male) Rabbit 2 (Male) Rabbit 3 (Male) Rabbit 4 (Female) Rabbit 5 (Female) Rabbit 6 (Female)
Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva Cornea Iris Conjuctiva
1 0 0 12 10 0 12 10 0 12 0 0 0 0 0 0 0 0 0
2 0 0 6 10 0 10 10 0 8 0 0 0 0 0 0 0 0 0
3 0 0 6 5 0 8 5 0 6 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Cornea: 3.3 Iris: 0 Conjuctivae: 5.3 Cornea: 0 Iris: 0 Conjuctivae: 0

effect of rinsing R = unrinsed eyes 2.9

rinsed eyes 0

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was considered to be an non-irritant to rabbit eyes.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. In the present experiments the cornea, iris and conjunctivae scores were zero for rinsed eyes. Therefore, the test material was considered to be a non-irritant to rabbit eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:


A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0. In other supporting studies, FAT 20004 was found to be not irritating to the skin.


 


Eye Irritation:


A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. In the present experiments the irritation index was established as 1.7 for the cornea, 0 for the iris and 2.6 for the conjunctivae. The test material caused therefore a minimal overall eye irritation to rabbits. In other supporting studies, FAT 20004 was found to be not irritating to eyes.

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation potential, the substance does not have to be classified for skin irritation according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.

Base on the above assessment of the eye irritation potential, the substance does not have to be classified as for risk of serious damage to eyes according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.