Registration Dossier

Administrative data

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
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
Principles of method if other than guideline:
None
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals 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:
not specified
Controls:
not specified
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.



Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal: Six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
erythema score
Remarks:
(Abraded skin)
Basis:
animal: Six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal: six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
edema score
Remarks:
(Abraded skin)
Basis:
animal: Six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Irritant / corrosive response data:
No data
Other effects:
None

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 h mean reaction score of 6 rabbits  
erythema edema
intact skin  abraded skin intact skin abraded skin
24 0 0 0 0
72 0 0 0 0
subtotal 0 0 0 0
total 0        +       0      +        0      +          0    =     0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
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 o.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.

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Principles of method if other than guideline:
None
GLP compliance:
no
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:
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):
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.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
5.3
Remarks on result:
other: Unrinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Unrinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
3.3
Remarks on result:
other: Unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Remarks on result:
other: Rinsed
Irritant / corrosive response data:
no data
Other effects:
Not available

  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:
other: Minimla irritant
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
Under the study conditions, the test substance was considered to be an minimal overall eye irritant to rabbits.
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 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.

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 o.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 calculated primary irritation index was 0.Under the conditions of the present experiment, FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit 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.


Justification for selection of skin irritation / corrosion endpoint:
Basic data given, acceptable for assessment

Justification for selection of eye irritation endpoint:
Basic data given, acceptable for assessment

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.