Registration Dossier

Administrative data

Description of key information

FAT 65004 is to be considered as a non-irritant to the skin and eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals:
Healthy New Zealand White rabbits (Porton strain) aged 3 -• 4 months with average body weights of 3.73 Kgs. (male) and 3.30 Kgs. (female), bred on. the premises and maintained under a semi-barrier system. Six rabbits (3 male and 3 female) were acclimatized in the test area for one week prior to the start of the trial.
Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (±1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 15 hours daily from 08.00 - 23.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml. of the compound was applied on a 2.5 cm. square sterile gauze pad to each test site
Duration of treatment / exposure:
24 hrs
Observation period:
72 hrs
Number of animals:
6 aminals (3 male and 3 female)
Details on study design:
The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Twenty-four hours prior to the dermal application, the backs of the rabbits 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 rabbit. 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.

0.5 ml. of the compound was applied on a 2.5 cm. square sterile gauze pad to each test site. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" 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.

After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.
The assessment of the macroscopic skin reaction was made according to Draie grading system.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin reaction occurred
Other effects:
none

none

Interpretation of results:
GHS criteria not met
Conclusions:
Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.
Executive summary:

The test was carried out according to the method given in the"Hazardous Substances Regulations" under the U.S. Federal HazardousSubstances Labelling Act Sect. 191.11 (February 1965).

Healthy NewZealand White rabbits (Porton strain) aged 3 -4months with average body weights of 3.73 Kgs. (male) and 3.30 Kgs.(female),bred on. the premises and maintained under a semi-barriersystem. Six rabbits(3 maleand 3female) were acclimatized in the testarea for oneweek prior to the start of the trial.

 

Twenty-four hours prior to the dermal application, the backs ofthe rabbits were shaved over an area consisting of at least10%ofthe total body surface. Two test sites lateral to the mid line ofthe back were used on each rabbit. Immediately before theapplication of the test compound, the right hand site was abradedwiththe point of a sterile hypodermic needle. The abrasions weresufficiently deep to penetrate the stratum corneum but not to damagethe dermis. The left hand site remained intact.

 

0.5 ml. of the compound was applied on a 2.5 cm. squaresterile gauze pad to each test site.These were covered with aluminium foil secured with "Sleek" adhesivetape. The test sites were then enclosed by a 6" wide "Coban" selfadhesive bandage the edges of which were fixed to the skin by stripsof "Sleek" in order to retain the test substance in close contactwith the skin.

 

After 24 hours the dressing was removed and the intact andabraded application sites were assessed for oedema and erythema.A further assessment was made at 72 hours.

The assessment of the macroscopic skin reaction was madeaccording toDraiegrading system.

Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
Animals:
Six rabbits (3 male and 3 female) with average body weights of 1.4 to 1.7 kg were acclimatized to at least 8 days before the experiment.
Husbandry:
The rabbits were caged singly inmetal cages (47X32X34 cms) maintained at a temperature of 18°C. (±1°) and a relative humidity of 55±5 %. Animals were exposed to artificial light for 14 hours daily. A standard diet of Nafag and drinking water were given ad libitum.

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of the compound was applied on a 2.5 cm. square sterile gauze pad to each test site
Duration of treatment / exposure:
24 hrs
Observation period:
72 hrs
Number of animals:
6 aminals (3 male and 3 female)
Details on study design:
This test was aimed at finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits. 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) was followed.
Before starting, the animals were acclimatized for at least 8 days to a constant room temperature of 18±1°C, a relative humidity of 55±5% and 14 hours light/day. They were housed singly in metal cages (overall dimensions 47x32x34 cm), A standard diet of Nafag and drinking water were given ad libitum .

6 rabbits (3 male; 3 female) of the Russian breed, weighing 1.4 to 1.7 kg, were shaved one day before treatment with an electric clipper on the flanks. 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 the 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.

FAT65004/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. The reaction
of the skin was appraised upon removal during an observation period of 8 days.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1.2
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: slight irritation
Remarks:
abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.2
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: minimal irritation
Remarks:
intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Remarks on result:
other: No irritation
Remarks:
abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
other: No irritation
Remarks:
intact skin
Irritant / corrosive response data:
No skin reaction persisted after 72 hrs
Other effects:
none

none

Interpretation of results:
GHS criteria not met
Conclusions:
Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.
Executive summary:

This test was aimed at finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits.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) was followed.

Before starting, the animals were acclimatized for at least 8 days to a constant room temperature of 18±1°C, a relative humidity of 55±5% and 14 hours light/day. They were housed singly in metal cages (overall dimensions 47x32x34 cm), A standard diet of Nafag and drinking water were given ad libitum .

 

6 rabbits (3 male; 3 female) of the Russian breed, weighing 1.4 to1.7 kg, were shaved one day before treatment with an electric clipper on the flanks.The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5x2.5 cm laden with the 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.

 

FAT65004/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. The reaction

of the skin was appraised upon removal during an observation period of 8 days.

 

Results

Preparation FAT 65 004/A was found to cause minimal irritation (mean reaction score after 24 hours: 0.2) when applied to intact and slight irritation (mean reaction score after 24 hours: 1.2) when applied to abraded rabbit skin.

It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment.

 

Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
Animals:
Six rabbits (3 male and 3 female) with average body weights of 1.6 to 2.4 kg were acclimatized to at least 8 days before the experiment.
Husbandry:
The rabbits were caged singly inmetal cages (47X32X34 cms) maintained at a temperature of 18°C. (±1°) and a relative humidity of 55±5 %. Animals were exposed to artificial light for 14 hours daily. A standard diet of Nafag and drinking water were given ad libitum.

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of the compound was applied on a 2.5 cm. square sterile gauze pad to each test site
Duration of treatment / exposure:
24 hrs
Observation period:
7 days
Number of animals:
6 aminals (3 male and 3 female)
Details on study design:
This test was aimed at finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits. 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) was followed.
Before starting, the animals were acclimatized for at least 8 days to a constant room temperature of 18±1°C, a relative humidity of 55±5% and 14 hours light/day. They were housed singly in metal cages (overall dimensions 47x32x34 cm), A standard diet of Nafag and drinking water were given ad libitum .

6 rabbits (3 male; 3 female) of the Russian breed, weighing 1.6 to 2.4 kg, were shaved one day before treatment with an electric clipper on the flanks. 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 the 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.

FAT65004/B was applied to each side in quantities of 0.5 ml . The gauze patches were removed 24 hours after application. The reaction
of the skin was appraised upon removal during an observation period of 7 days.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.5
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: Minimial irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1.5
Reversibility:
fully reversible within: 96 hrs
Remarks on result:
other: minimal irritation
Remarks:
abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
other: no irritation
Remarks:
intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.3
Reversibility:
fully reversible within: 96 hrs
Remarks on result:
other: minimal irritation
Remarks:
abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.3
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: minimal irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.8
Reversibility:
fully reversible within: 96 hrs
Remarks on result:
other:
Remarks:
abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Remarks on result:
other: no irritation
Remarks:
intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0.3
Reversibility:
fully reversible within: 96 hrs
Remarks on result:
other:
Remarks:
abraded skin
Irritant / corrosive response data:
No skin reaction persisted after 96 hrs (4 days) on the abraded skin
Other effects:
none

none

Interpretation of results:
GHS criteria not met
Conclusions:
Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.
Executive summary:

This test was aimed at finding out the primary irritation index as a measure of the acute irritation on the skin of rabbits.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) was followed.

Before starting, the animals were acclimatized for at least 8 days to a constant room temperature of 18±1°C, a relative humidity of 55±5% and 14 hours light/day. They were housed singly in metal cages (overall dimensions 47x32x34 cm), A standard diet of Nafag and drinking water were given ad libitum .

 

6 rabbits (3 male; 3 female) of the Russian breed, weighing 1.6to2.4kg, were shaved one day before treatment with an electric clipper on the flanks.The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5x2.5 cm laden with the 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.

 

FAT65004/Bwas applied to each side in quantities of 0.5ml. Before application the test material was wetted with tap water.The gauze patches were removed 24 hours after application. The reaction

of the skin was appraised upon removal during an observation period of 7days.

 

Preparation FAT 65004/B was found to cause minimal irritation

when applied to intact, and moderate irritation when applied to

abraded rabbit skin.

The reaction consisted of very slight to slight erythema and

edema.

The calculated skin irritation index was 0.9.

 

It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment.

Compound FAT 65 004 is not a primary skin irritant in the albino rabbit.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
A cream coloured liquid labelled FAT 65 004
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The substance was tested on 6 rabbits (3 male and 3 female) of the Russian breed (obtained from the breeder, weighing 1.4 to 1.7 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 enviroment in our laboratories. They were kept at a constant temperature of 18±1 C° and relative humidity of 55±5%, with 14 hours light/day. Only rabbits showing normal ophthalmic findings
were included in the test.

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
Six rabbits (3 male and 3 female)
Details on study design:
The 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) was followed.

Amounts of 0.1ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe. 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 6 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
Other effects / acceptance of results:

None
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 65 004 is not an eye irritant in the albino rabbit.
Executive summary:

The 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) was followed to assess the eye irritation potential of test substance FAT 65004/A when exposed to rabbit eye.

Amounts of 0.1ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe. 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 6 days on the basis of "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

Minimal transient conjunctival reaction (mean reaction score: 2 after 1 and 6 hours) was noted in one single animal.

FAT 65 004/A was found to be practically non irritant when applied to the rabbit eye mucosa.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
A cream coloured liquid labelled FAT 65 004
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy New Zealand White rabbits (Porton strain) aged 3 - 4 months with average body weights of 3.73 kgs. (male) and 2.83 kgs. (female), bred on the premises and maintained under a semi-barrier system.
Six rabbits (3 male and 3 female) were acclimatised in the test area for one week prior to the start of the trial.

The rabbits were caged singly in an experimental room maintained at a temperature of 20±1 C°, and a relative humidity of 50-70%. Animals were exposed to artificial light for 15 hours daily from 08.00 - 23.00 hours. A commercial irradiated diet
(Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
Six rabbits (3 male and 3 female)
Details on study design:
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 Labeling Act Sect.. 191.12 (February 1965), with slight modification.
The eyes of the experimental animals were examined and found normal prior to the test.
0.1 ml. of the test compound was instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with 30 ml. of warm sterile water. The rabbits were examined 1, 6, 24, 43 and 72 hours after application of the test compound and for any further period that was considered necessary. 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 USA.

Other effects / acceptance of results:

None
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Up to 1 hour after application compound was visible in 4/6 animals. No eye reactions occurred.
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Compound FAT 65 004/A is not an eye irritant in the albino rabbit.
Executive summary:

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 Labeling Act Sect.. 191.12 (February 1965), with slight modification.

In the experiment to assess the eye irritation potential od FAT 65004/A healthy New Zealand White rabbits (Porton strain) aged 3 - 4 months with average body weights of 3.73 kgs. (male) and 2.83 kgs.

(female), bred on the premises and maintained under a semi-barrier system were used. Six rabbits (3 male and 3 female) were acclimatised in the test area for one week prior to the start of the trial.

The eyes of the experimental animals were examined and found normal prior to the test.

0.1 ml. of the test compound was instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with 30 ml. of warm sterile water. The rabbits were examined 1, 6, 24, 43 and 72 hours after application of the test compound and for any further period that was considered necessary. 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 USA.

Up to 1 hour after application compound was visible in 4/6 animals. No eye reactions occurred.

Compound FAT 65 004/A is not an eye irritant in the albino rabbit.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female rabbits of the Russian breed weighing 1.7 to 2.0 kg. The animals were housed individually in metal cages (overall dimensions 47x32x34 cm), were kept at a constant room temperature of 18±1 C°, at a
relative humidity of 55±5 % and on a 14 hour light cycle day.
The animals had ad libitum access to standard rabbit food - NAFAG,Gossau SG - and water. Prior to treatment they were adapted toour laboratories for a minimum of 8 days. Only rabbits with normal ophthalmic findings were used for these tests.
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Few sec
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
Six rabbits (3 male and 3 female)
Details on study design:
The procedure used was the test for eye irritants described in the "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 ml was inserted into the conjunctival-sac of the left eye of the 6 rabbits and the lids were held open for a few seconds. The right eye was not treated and served as a control. In 3 of the 6 rabbits approximately
1 minute after treatment both eyes were rinsed with physiologic saline.
The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days and scored for each individual rabbit as outlined in the data sheet.

Other effects / acceptance of results:

None
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
None
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
Compound FAT 65 004/B is not an eye irritant in the albino rabbit.
Executive summary:

A study was conducted to assess the eye irritation potential of test substance FAT 65004/B when exposed to the rabbit eye. The procedure used was the test for eye irritants described in the "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 ml was inserted into the conjunctival-sac of the left eye of the 6 rabbits and the lids were held open for a few seconds. The right eye was not treated and served as a control. In 3 of the 6 rabbits approximately

1 minute after treatment both eyes were rinsed with physiologic saline.

The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days and scored for each individual rabbit as outlined in the data sheet.

Preparation FAT 65 004/B was found to cause no conjunctival reaction after 1 hour when applied to the rabbit eye mucosa.

FAT 65 004/B is 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

Skin:

There are 3 key studies available to evaluate the skin irritation potential of FAT 65004.

In all the three key studies6 rabbits (3 males and 3 females), were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g/of the solid was mixed to a paste with 0.5ml of water before application to each treatment siteor 0.5ml unchanged test substances was applied and thepatch was covered with an impermeable foil, which was fixed to the body of the animals with adhesive tape.

After 24 hours exposure, the patches were removed and the resulting reactions were evaluated.The reactionof the skin was appraised upon removal during an observation period of 7daysstarting 24 hrs.

In all the three studiesPreparation FAT 65004 was found to cause minimal irritationwhen applied to intact, and moderate irritation when applied toabraded rabbit skin.The reaction consisted of very slight to slight erythema andedema.All the reactions were completely reversible by the end of 72-96 hrs.

 

It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment.

In another (support study) repeated application study5 ml of the test material were distributed evenly onto a gauze patchof 4 x 5 cm and placed on one side of the animal while another gauzepatch (Carboxymethylcellulose 0.5% ) was placed on the other side of the animalfor a control. These patches were covered with occlusive dressingsand secured with an adhesive tape without contact between adhesivetape and the depilated skin.Dressing and test material were removed very carefully after 24 hoursand the skin reaction evaluated according to Draize ("Appraisal ofthe Safety of Chemicals in Foods, Drugs and Cosmetics", 1959 ofthe AFD0)with the aid of theevaluation scheme.This procedure was repeated for a total of 5 consecutive days. Thefifth dressing was removed 8 hours after the application and the skinreaction recorded.The skin reaction was recorded again on day 8. Preparation FAT 65 004 was found to cause increasing irritation from slight (day 1) to extreme (day 4) when applied repeatedly to the rabbit skin. This data is not been considered for evaluation here since this study deals with repeated application of the test substance over a period of 5 days.

 

Based on the data from three key studies its concluded that test substance FAT 65 004 is not-irritating to rabbit skin

Eye:

Three studies are available adressing the eye irritation potential of the test substance FAT 65004. Test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation and observed over a period of 8 days. Test reults in all the three studies indicate FAT 65004 to be practically non irritant when applied to the rabbit eye mucosa.

Justification for classification or non-classification