Registration Dossier

Administrative data

Description of key information

Reactive Red 065 is non-irritant to rabbit skin and eye.

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:
October 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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:
Irritation potency of FAT 40062/A on the rabbit skin of both sexes observed over a period of 72 hours by treating with 0.5 g of the test substance.
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Huntsman/ CIBA-GEIGY Limited
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Kept separately in V2A wire cages,
- Diet: (NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
with electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of test substance FAT 40062/A was applied to each side.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 rabbits (3 males/ 3 females)
Details on study design:
Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs,were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance (0.5 g) and immediately applied to the prepared skin. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it.
Irritation parameter:
erythema score
Remarks:
Intact and scarified skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified skin
Basis:
mean
Remarks:
6 rabbit
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
6 rabbit
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No adverse effects were observed after treatment.
Other effects:
None
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40062/A is to be considered as non-irritant to the rabbit skin.
Executive summary:

Test was performed to evaluate irritant effects after single application of FAT 40062/A on rabbit Skin by following 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). Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the Russian breed rabbits, clipped free of hair. Six rabbits (3 males/3 females) weighing 1.5 to 2 kgs,were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages. The shaven skin on the left side was slightly scarified immediately before treatment by application of 50 % Polyethylene glycol trituration (PEG 400). A gauze patch 2.5 x 2.5 cm was soaked with the test substance (0.5g) 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. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index along with erythema and edema to the skin of rabbits was found to be '0'. Therefore, FAT 40062/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:
October 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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:
Irritation potency of FAT 40062/A in the rabbit eyes of both sexes observed over a period of 7 days by treating with 0.1 g of the test substance.
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Huntsman/ Ciba-Geigy
- Housing: Kept separately in V2A wire mesh cages
- Diet: NAFAG, Gossau SG (Rabbit food) ad libitum
- Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males / 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 10 ml lukewarm water
- Time after start of exposure: 30 seconds

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Remarks:
Eyes rinsed and eyes not rinsed
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Eyes rinsed and eyes not rinsed
Basis:
mean
Remarks:
6 rabbitts
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Eyes rinsed and eyes not rinsed
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
Other effects:
None
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40062/A is to be considered as non-irritant to the eye of rabbits.
Executive summary:

FAT 40062/A, was evaluated for primary eye irritation after instillation of 0.1 g of the test substance into the conjunctival sac of the left eye of 6 rabbits (3 males/ 3 females) of the Russian breed, which were kept separately in V2A wire mesh cages. After application, the eyelids were held open for a few seconds. The right eye served as a control. Only rabbits showing normal ophthalmic findings were included in the test. The eyes of 3 of these 6 rabbits were rinsed with 10 ml of lukewarm water about 30 seconds after treatment. The treated eyes of all animals (washed and unwashed) were evaluated after 24 h and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) 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 for the conjunctivae.

Therefore, FAT 40062/A is to be considered as non-irritant to the eye of rabbits.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

Test was performed to evaluate irritant effects after single application of FAT 40062/A on rabbit Skin according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the Russian breed rabbits. Six rabbits (3 males/3 females) were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages. The shaven skin on the left side was slightly scarified immediately before treatment by application of 50 % Polyethylene glycol trituration (PEG 400). A gauze patch 2.5 x 2.5 cm was soaked with the test substance (0.5g) 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.The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index along with erythema and edema to the skin of rabbits was found to be '0'. Therefore, FAT 40062/A is to be considered as non-irritant to the skin of rabbits.

Eye Irritation:

FAT 40062/A, was evaluated for primary eye irritation after instillation of 0.1 g of the test substance into the conjunctival sac of the left eye of 6 rabbits (3 males/ 3 females) of the Russian breed, which were kept separately in V2A wire mesh cages. After application, the eyelids were held open for a few seconds. The right eye served as a control. The eyes of 3 of these 6 rabbits were rinsed with 10 ml of lukewarm water about 30 seconds after treatment. The treated eyes of all animals (washed and unwashed) were evaluated after 24 h and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) 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' for the conjunctivae. Therefore, FAT 40062/A is to be considered as non-irritant to the eye of rabbits.

Justification for classification or non-classification

Based on the findings in the skin irritation as well as eye irritation studies, Reactive Red 065 does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 to be irritating to the skin and eye.