Registration Dossier

Administrative data

Description of key information

FAT 20035/A was found to be non-irritant when applied to the intact or abraded rabbit skin as well as to rabbit eye mucosa.

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: We used the patch test technique as 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).
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation:1.9 to 2.2 kg
- Housing:They were housed singly in metal cages (overall dimensions 47x32x34 cm).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18+-1
- Humidity (%):55+-5
- Photoperiod (hrs dark / hrs light):14 hours light/day
Type of coverage:
not specified
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6 rabbits (3 males and 3 females)
Details on study design:
The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g . Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application.

Assessment of irritation
0 = none
>0-1 = minimal
>1 - 2 = slight
>2 - 4 = moderate
>4 - 6 = marked
>6 - 8 = extreme
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Reversibility:
no data
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:
Preparation FAT 20035/A was found to be non-irritant when applied to intact or abraded rabbit skin.
Executive summary:

A in vivo test was carried out for finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits with test compound FAT 20035. The method followed was patch test technique as 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).

6 rabbits (3 male and 3 female) were observed for 7 days after test substance application. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. FAT 20 035/A was applied to each side in quantities of 0.5 g . Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application.

Results showed no adverse reactions at all at any experimental time period. Under the conditions of this experiment FAT 20035/A was found to be non-irritant when applied to the intact or abraded rabbit skin.

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: technique as 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).
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation:1.8 to 2.2 kg
- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18+-1
- Humidity (%):55+-5
- Photoperiod (hrs dark / hrs light):14 hours light/day

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:
1 minute
Observation period (in vivo):
1, 2,3 and 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):The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.

SCORING SYSTEM:
0-10 = minimal
11 - 25 = slight
26 - 55 = moderate
56 - 85 = marked
86 - 110 = extreme

TOOL USED TO ASSESS SCORE: slit lamp
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
4
Reversibility:
not specified
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:
FAT 20035/A was found to be practically non irritant when applied to the rabbit eye mucosa.
Executive summary:

A study was performed to determine the eye irritation potential of FAT 20035/A on rabbits. Test method was followed as 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).

The substance was tested on 6 rabbits of the Russian breed (obtained from the breeder , weighing 1.8 to 2.2 kg) which were kept separately in metal cages (overall dimensions 47x32x34cm) and fed with standard diet of Nafag and drinking water ad libitum. The animals were acclimatized to the environment in our laboratories. They were kept at a constant temperature of 18+_1 degree C and relative humidity of 55+5%, with 14 hours light/day. Only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.l g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with physiologic saline.

The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3 and 7 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. Preparation FAT 20035/A was found to be practically non-irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes.

It can be concluded that FAT 20035/A is practically non irritant when applied to the rabbit eye mucosa.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A in vivo test was carried out for finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits with test compound FAT 20035. The method followed was patch test technique as 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). Results showed no adverse reactions at all at any experimental time period. Under the conditions of this key experiment FAT 20035/A was found to be non-irritant when applied to the intact or abraded rabbit skin.

A study was performed to determine the eye irritation potential of FAT 20035/A on rabbits. Preparation FAT 20035/A was found to be practically non-irritant when applied to the rabbit eye mucosa. Minimal transient conjunctival reaction was noted 1 and 6 hours following instillation. After 24 hours, all findings were negative in 2/3 unrinsed and 1/3 rinsed eyes.

Based on the results on in vivo skin and eye tests, FAT 20035/A can be regarded as practically non-irritant to rabbit skin and eyes.


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 finding in the skin and eye irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.