Registration Dossier

Administrative data

Description of key information

Acid Blue 185 is neither a skin nor an eye irritant.

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:
February 2, 1981 to February 9, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to
Guideline:
other: United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
Deviations:
not specified
Principles of method if other than guideline:
Guideline followed
GLP compliance:
no
Specific details on test material used for the study:
- Physical appearance: blue powder
- Batch No.: WS 42065.02
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. They were housed individually in metal cages numbered by ear tags, were kept at a constant room temperature of 22 ± 2°C, at a relative humidity of 55 ± 10 % and on a 10 hours light cycle day. The animals received, ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted to our laboratories for a minimum of 4 days.
Type of coverage:
occlusive
Preparation of test site:
other: Shaved intact and abraded skin
Vehicle:
other: polyethylene glycol (PAG 400) + saline (70 : 30 parts)
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.35
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72 h
Score:
0.35
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).

Calculation of the primary skin irritation index:

Time after exposure (h)

Erythema

Edema

Intact skin

Abraded skin

Intact skin

Abraded skin

24

0.7

1.3

0.7

1.3

72

0

0

0

0

Total

0.7

1.3

0.7

1.3

primary irritation index = 4.0 : 4 = 1.0

Interpretation of results:
GHS criteria not met
Conclusions:
The substance can be considered as not skin irritating.
Executive summary:

The skin irritation potential of the test substance was evaluated in a study conducted according to the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5x2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. The scores after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index eryhema was assumed to be equal to edema based on the correlation existing. The erythema and edema observed at 24 hours observation was found to have reversed at 72 hour observation. The primary irritation index was calculated to be 1.0. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP [Regulation (EC) No. 1272/2008]. Hence, the substance can be considered as not skin irritating.

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:
February 2, 1981 to February 9, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to
Guideline:
other: Proposed guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritatioirritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
Deviations:
no
Principles of method if other than guideline:
Guideline followed
GLP compliance:
no
Specific details on test material used for the study:
Physical appearance: blue powder
Batch No.: WS 42065.02
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The test was performed on 3 male and 3 female New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. The animals were housed individually in metal cages, numbered by ear tags, were kept at a constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and on a 10 hour light cycle day. The animals had ad libitum access to standard rabbit food - NAFAG, No. 814, Gossau SG - and water. Prior to treatment they were adapted for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye was not treated and served as an untreated control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline, while for remaining 3 rabbits the treated eyes were not washed .
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 96 hours
Remarks on result:
other: Total score for conjuctival redness/total number of observations= 12/18= 0.67
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Total score for conjuctival redness/total number of observations= 4/18= 0.22
Irritant / corrosive response data:
- A slight persistant blue coloration of the sclera was observed throughout the test.
- FAT 20'063/B was found to cause a minimal irritation when applied to the rabbit eye mucosa.
- Rinsing the eyes following instillation was of no effect.

None

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance can be considered as not an eye irritant.
Executive summary:

The eye irritation potential of the test substance was evaluated in a study conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female New Zealand White rabbits weighing 2 to 3 kgs. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. A slight persistant blue coloration of the sclera was observed throughout the test. Primary irritation index in unrinsed as well as rinsed eyes was 1.1. Hence the test substance was found to cause a minimal irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of no effect. However, the scores do not meet the CLP [Regulation (EC) No. 1272/2008] criteria for classification, hence the test substance can be considered as not irritating to eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Two studies for assessment of the skin irritation potential of Acid Blue 185 are available.

In a key study, the skin irritation potential of the test substance was evaluated according to the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. The test was performed on 3 male and 3 female adult New Zealand White rabbits bred and raised on the premises weighing 2 to 3 kgs. Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "SchröpfSchnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. The scores after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing. The erythema and edema observed at 24 hours observation was found to have reversed at 72 hour observation. The primary irritation index was calculated to be 1.0. However, the scores for erythema and edema do not meet the classification criteria proposed by CLP [Regulation (EC) No. 1272/2008]. Hence, the substance can be considered as not a skin irritant.

In a supporting study, the skin irritation of the FAT 20063/A was evaluated according to 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, 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 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. FAT 20063/A 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 24 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 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. No erythema or edema were seen during the observation period. The primary irritation index of FAT 20063/A was 0. Based on the findings of the study, it can be concluded that FAT 20063/A is not a skin irritant.

Since no skin irritation observed in the above studies, target substance Acid Blue 185 can be considered as not a skin irritant.

Eye irritation:

Two studies are available to evaluate the eye irritation potential of the target substance.

In a key study conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978, 3 male and 3 female New Zealand White rabbits weighing 2 to 3 kgs were used for testing. The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively. A slight persistant blue coloration of the sclera was observed throughout the test. Primary irritation index in unrinsed as well as rinsed eyes was 1.1. Hence the test substance was found to cause a minimal irritation when applied to the rabbit eye mucosa. Rinsing the eyes following instillation was of no effect. However, the scores do not meet the CLP [Regulation (EC) No. 1272/2008] criteria for classification, hence the test substance can be considered as not an eye irritant.

In a supporting study, the eye irritation potential of the test substance was evaluated according to the 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). 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, they 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" (1959) of the AFDO. The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Hence, the test substance can be considered as not an eye irritant.

Since the available studies did not indicate the substance to be an eye irritant. Hence, target substance Acid Blue 185 can be considered as not an eye irritant.

Justification for classification or non-classification

Based on the findings of the above studies, the substance does not warrant classification for skin and/or eye irritation as per the CLP [Regulation (EC) No. 1272/2008] criteria.