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Description of key information

Not skin irritating

Not eye irritating

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
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 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Water: e.g. ad libitum.
- Health check: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours.
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: DMSO
Remarks:
the test item was prepared immediately before dosing
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1.0 ml of the solution.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
Three males and three females
Details on study design:
TEST SITE
- Area of exposure: test item was introduced under a square patch of surgical gauze, measuring 6.5 cm^2.
- Type of wrap if used: the animals vrere immobilzed with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.

SCORING SYSTEM
After 24 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulation, title 16, Section 1500.41.
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritant / corrosive response data:
The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity.
Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Not irritating
Executive summary:

Six rabbits (three males and three females) were used to test the skin irritation potential of the substance. The abraded and intact skin of rabbits was treated with 1.0 ml of test solution. The irritation was measured by patch test technique on the intact skin. After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

None of the animals showed any observable response to treatment throughout the 72 hours observation period.

The irritation score was 0.0 and the substance has been judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.

Conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC) No 1272/2008.

None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.

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
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:
Powdered formulation.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: a standard laboratory diet was provide ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Water: e.g. ad libitum.
- Health check: prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Nine rabbits: six rabbits for unwashed eyes and three addtional rabbits whose eyes were washed after instillation.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: in three animals, the treated eye was rinsed with 20 ml lukewarm water.
- Time after start of exposure: after half a minute.

OBSERVATION TIME
The eyes were inspected after 24, 48 and 72 hours.

SCORING SYSTEM:
Reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).
Irritation parameter:
cornea opacity score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
iris score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 1
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
conjunctivae score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 2
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
chemosis score
Basis:
animal: 9/9
Time point:
24/48/72 h
Score:
< 2
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritant / corrosive response data:
The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity.

Reactions - unwashed eyes

Animal Reaction 24 hrs 48 hrs 72 hrs
Male 701 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 702 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 703 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 704 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 705 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 706 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0

Reactions - washed eyes

Animal Reaction 24 hrs 48 hrs 72 hrs
Male 707 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 708 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Male 709 Cornea (A) density 0 0 0
(B) area 0 0 0
AxBx5 0 0 0
Iris (C) 0 0 0
Cx5 0 0 0
Conjunctiva (D) secretion 0 0 0
(E) swelling 0 0 0
(F) redness 0 0 0
(D+E+F)x2 0 0 0
Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
Not irritating
Executive summary:

Nine rabbits (New Zealand White Rabbits) were used in the test: six animals for unwashed eyes and three animals whose eyes were washed after instillation. Prior to the test, the eyes of each rabbit were examined for pre-existing casual injury.

100 mg of the test material was placed into the conjunctival sac of the right eyes of the animals. In three animals, the treated eye was rinsed after half a minute. The eyes were inspected after 24, 48 and 72 hours. Reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

The irritation score resulted to be 0, thus, the test item was judged to be non irritant, according to the systen of classification recommended by the ETAD Subcommittee for toxicity.

Conclusion

The scoring system criteria used to record the hardness of the skin reactions followed in the current test are strictly comparable to those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC) No 1272/2008.

None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION

The potential for skin irritation of Disperse Red 054 was assessed in rabbits. The irritation was measured by patch test technique on the intact and abraded skin. The reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41. None of the animals showed any observable response to treatment throughout the 72 hours observation period. The irritation score was 0.0 and the substance has been judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.

Additional experiments, conducted on Direct Red 054 , are available; however, they were performed using a sample with a limited content of test item, thus, they are here reported just as a supporting studies.

In both the supporting studies cases, the procedures employed were those prescribed by the consurner product safety commission of the U.S.A, according to the ETAD method No 002.

In one case, the primary irritation index was found to be 0.8 and the substance was judged to be slightly irritating, according to the ETAD-Subcommittee for Toxicology.

In the other case, very slight oedema only was observed in the intact and abraded sites of two animals at the 24 hours reading; similar reactions were observed in one of these animals at the72 hours reading. However, four animals did not show ony observable response to treatment throughout the 72 hours observation period. The primary irritation index was estimated to be 0.3 and the substance was judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.

EYE IRRITATION

The potential for eye irritation of Disperse Red 054 was assessed in rabbits. Nine animals were used in the test: six animals for unwashed eyes and three animals whose eyes were washed after instillation. The eyes were inspected after 24, 48 and 72 hours and the reading score for ocular lesions were made according to the recommendations of the USA Food and Drug officials, published in 1959 (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics).

The irritation score resulted to be 0, thus, the test item was judged to be non irritant, according to the systen of classification recommended by the ETAD Subcommittee for toxicity.

In addition a second experiment, conducted on Direct Red 054 , is available; however, it was performed using a sample with a limited content of test item, thus, it is here reported just as a supporting studies. The substance was tested in six rabbits, which were treated with 66 mg of test item. The ocular reactions were scored by the method described by J.H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs ond Cosmetics" p 51, 1959 and categorized from the mean values as recornmended by the ETAD Sub-committee for Toxicology. Mild coniunctival inflammation was observed in three animals 24 hours after instillation only. Three animals did not show any observable response to treatment throughout the 7 day observation period. The mean Draize score at days 1, 2 and 3 resulted to be 0.2 and the test item was judged to be "non irritant".

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In the key experiment, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.

According to the CLP Regulation (EC) No 1272/2008, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application.

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all of the tested animals.

In conclusion, the substance does not meet the criteria to be classified for the eye/skin irritation, according to the CLP Regulation (EC) No 1272/2008.