Registration Dossier

Administrative data

Description of key information

FAT 40061 is considered to be non- irritant to skin and minimal irritant to the eye 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:
1974
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) of 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:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Separately in V2A wire cages.
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water : ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: shaved and sacrificed skin
Vehicle:
other: 50 %.polyethylene glycol trituration (PEG 400)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
FAT 40061/A was applied to each side in quantities of 0.5 g. Before application a 50 %.polyethylene glycol trituration (PEG 400) was made.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males and 3 females
Details on study design:
A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic
film 5 x 5 cm, which was fixed to the body with adhesive tape.

SCORING SYSTEM:
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
Total possible edema score: 4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: 24-72 hours
Score:
0
Remarks on result:
other: Intact skin and scarified skin.
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants.
The primary irritation index of FAT 40061/A was 0
Executive summary:

The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits.

The primary irritation index as the measure of the acute irritation to the skin of rabbits was -found to be 0.

Therefore FAT 40061/A is to be considered as non-irritant to the skin of 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:
1974
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) of the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: separately in V2A wire cages and fed on NAFAG, Gossau SG.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
One application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30 seconds after treatment
- Time after start of exposure: after 24 hours

SCORING SYSTEM:
Evaluation of the Eye Reactions

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
A x B x 5 Total maximum = 80

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, hemorrhage, gross destruction (any or all of these) 2
A x 5

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 adj acent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A + B + C) x 2 Total maximum = 20

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: slit-lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: day 1 to 7 after application
Score:
0
Remarks on result:
other: Eye not rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: day 1 to 7 after application
Score:
0
Remarks on result:
other: Eye not rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
other: day 1 to 7 after application
Score:
0.5
Remarks on result:
other: Eye not rinsed
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
other: minimal irritant
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.
Executive summary:

The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.

Therefore FAT 40061/A is to be considered as a minimal irritant to the eye of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A study was conducted to assess the potential of FAT 40061 to cause acute irritation on the rabbit skin. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

Six rabbits (3 males/3 females) of the Russian breed were used in the occlusive patch test. FAT 40061 was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it.

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore FAT 40061 is to be considered as non-irritant to the skin of rabbits.

To assess the acute eye irritation potential of FAT 40061 when exposed to rabbit eye, a study was performed in accordance to the procedure mentioned in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59) of the AFDO.

The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, their eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59) of the AFDO.

The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.

Therefore FAT 40061 is considered to be as a minimal irritant to the eye of rabbits.


Effects on eye irritation: slightly irritating

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.