Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

Endpoint summary

Description of key information

FAT 40210 should be considered as not irritating to the skin and eyes.

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:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive testing conditions represent elevated testing conditions compared to OECD guideline 404

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The test was performed on 1 male and 2 female rabbits, weighing between 2.5 to 3.0 kg (approx. 15-16 weeks old). The acclimation was 4 days under laboratory conditions after veterinary examination. Body weights were measured on day 1 and at termination of test.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: moistened with tap water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

on the test day 1, 0.5 g test article was applied to the intact skin of the shaved area. The test article was moistened with tap water.

Duration of treatment / exposure:

four hours

Observation period:

at 1, 24, 48, 72 hrs intervals after the removal of the dressing, gauze patch and test article.

Number of animals:

1 male and 2 females

Details on study design:

Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10×10 cm). On test day 1, 0.5 g of the test article was applied to the intact skin of the shaved area. It was covered with a 3.0×3.0 cm patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. Four hrs after the application, the dressing was removed and the skin was flushed with lake warm tap water.
at 1,24,48,72 hrs after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

other: 1 hr

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

other: 1 hr

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None

Other effects:

In the area of application a black discoloration of the skin was observed.

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40210/A was not found to cause a primary skin irritation when applied to intact rabbit skin.

Executive summary:

A key study was performed to determine the skin irritation of FAT 40210/A according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

There were 1 male and 2 female rabbits used in this test under the standard laboratory conditions. In the area of application a black discolouration of the skin was observed which could be related to effects of the test article. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.

Under the conditions of this experiment, FAT 40210/A was found to cause a primary irritation score of 0 when applied to intact rabbit skin, which shall not be classified according to CLP Regulation (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

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Principles of method if other than guideline:

None

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The test was performed on 1 male and 2 female rabbits, weighing between 2.5 to 2.7 kg (approx. 15-16 weeks old). The acclimation period was 4 days under laboratory conditions after veterinary examination.

Vehicle:

unchanged (no vehicle)

Controls:

other: The opposite eye was right untreated and served as the control

Amount / concentration applied:

0.1 g per animal

Duration of treatment / exposure:

examination at 1, 24, 48, 72 h after administration with a single dose.

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

1 male and 2 females were used in this test under the standard lab conditions. The test substance was applied undiluted. A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal. Body weights were measured on day 1 and at termination of test. The eyes of each animal were examined 1, 24, 48 and 72 h after administration. The corrosive properties of the test article and the colour of the treated eye were described and recorded.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

1 male and 2 females

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

overall irritation score

Basis:

other: mean of 1 male and 2 females

Time point:

other: 1 - 72 hrs

Score:

0.5

Max. score:

13

Reversibility:

fully reversible

Irritant / corrosive response data:

No corrosion of cornea was observed at any of the measuring intervals.

Other effects:

In the area of application a severe bluish-black discolouration of the cornea and conjunctivae was observed. No acute toxicity symptoms were observed and no mortality occurred during the test period.

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40210/A was found to cause a primary irritation scored of 0.5 when applied to the rabbit eye mucosa.

Executive summary:

A key study was performed to determine the eye irritation of FAT 40210/A according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).

1 male and 2 females were used in this test under the standard lab conditions. The test substance was applied undiluted. A single dose was administered to the left eye of each animal. A severe bluish-black discolouration of the cornea and conjunctivae of the treated eyes was observed which could be related to the colour proper to the test article. No corrosion was observed at any of the measuring intervals. The mean value of the scores for cornea, iris, conjunctivae chemosis is 0, otherwise the score for conjunctivae redness is 0.3 after 24 -72 h.

No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. FAT 40210/A showed a primary irritation score of 0.5 when applied to the rabbit eye mucosa, which shall not be classified according to CLP Regulation (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:

A GLP-compliant study was performed to determine the skin irritation of FAT 40210 according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). 1 male and 2 female rabbits used in this test. In the area of application, a black discolouration of the skin was observed which could be related to effects of the test article. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. 

Another study was performed to determine the skin irritation potential of FAT 40210 according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion). The 3 females were used in this test. The skin reactions observed were reversible until the end of the observation period on day 3. The mean value of individual reaction scores of erythema is 0.33, and the score of oedema is 0. Under the experimental conditions employed FAT 40210//B did not induced erythema and oedema reactions when applied to the shaved albino rabbit skin. Based on the results FAT 40210/A shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).

The two other supporting studies conducted in 1979 and 1975 in accordance to the test procedure as described in Code of Federal Regulations also support the outcome that the substance should be considered as not irritating to the skin.

Eye irritation:

A GLP-compliant study was performed to determine the eye irritation of FAT 40210 according to OECD Guideline 405 (Acute Eye Irritation / Corrosion). The test substance was applied undiluted in the left eye of 1 male and 2 females rabbits.  A severe bluish-black discolouration of the cornea and conjunctivae of the treated eyes was observed which could be related to the colour proper to the test article. No corrosion was observed at any of the measuring intervals. The mean value of the scores for cornea, iris, conjunctivae chemosis is 0, otherwise the score for conjunctivae redness is 0.3 after 24 -72 hrs. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. FAT 40210/a showed a primary irritation score of 0.5 when applied to the rabbit eye mucosa, which shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).

Another study was performed to determine the skin irritation potential of FAT 40210 according to OECD Guideline 405(Acute Eye Irritation / Corrosion). The test performed on 3 females showed conjunctiva when applied into the conjunctival sac. No adverse effects were observed with cornea and iris of all animals. The eye reactions observed were reversible until the end of the observation period on day 7.

The test substance was tested for occular irritation potential in this study (1979) in accordance with Code of Federal Requlations, Title 16, Section 1500, 41. 100 mg test substance was instilled in the eye of 6 rabbits and observed for irritation parameters. The mean ocular irritation index obtained was 11. However, the scores obtained were below the thresholds required for classification, hence the test substance can be considered to be not irritating to the eyes as per the Regulation (EC) No. 1272/2008.

In a study conducted in 1975, the substance (Procion Black H-N) was tested for eye irritation in a study conducted according to Code of Federal Regulations, Title 16, Section 1500, 42. The scores obtained were 0, 0, 0.5 and 0.83 for corneal opacity, iris, conjunctival redness and chemosis respectively. Hence, it can be concluded that Procion Black H-N was negative for eye irritation, according to the definition given in the Code of Federal Regulations.

Based on the results FAT 40210/A shall not be classified according to CLP Regulation (Regulation EC No. 1272/2008).

Considering the data from skin and eye irritation/corrosion studies, it can be concluded that FAT 40210/A is non-irritating to skin and eye of rabbits. Hence not classified according to CLP Regulation (Regulation EC No. 1272/2008).

Justification for classification or non-classification

Based on the above stated assessment of the skin irritation potential of Reactive Black 8 the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European Parliament and of the Council.

 

Based on the above assessment of the eye irritation potential of Reactive Black 8 the substance does not have to be classified according to Council Directive 2001/59/EC and according to CLP (Regulation (EC) No 1272/2008 Of the European Parliament and of the Council.