A mixture of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate

Endpoint summary

Description of key information

The test substance is considered as non-irritant to rabbit skin as well as 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:

17 July 1992 to 29 September 1992

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:

not specified

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are 3 females.
TEST ANIMALS
- breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- acclimatisation period: at lease 5 days
- Weight at study initiation: 2540-2670 g
- Housing: individually in metal cages
- Feed: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): a 12 hrs light cycle day

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

distilled water

Controls:

other: a control gauze patch was applied to the contralated flank

Amount / concentration applied:

0.5 g of the test article was applied to the right flank of the shaved area. It was covered with a 12-16 cm² gauze patch. The gauze was covered with aluminium foil and held in place for 4 hours by an adhesive tape.

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 females

Details on study design:

An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 3 6 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The application area was red-stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero.

Other effects:

No edema formation was observed during an observation period of 7 days.

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 45155/B was found to cause no irritation when applied to intact rabbit skin.

Executive summary:

A GLP-compliant study was performed to access the primary skin irritation potential when single doses of FAT 45155/B are placed on the skin of New Zealand White rabbits. The study was carried out according to OECD guideline 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 3 6 cm²) and held in place for 4 hours by an adhesive tape. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches. No edema formation was observed during an observation period of 7 days. The application area was red stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore, the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero. Based on the study results, FAT 45155/B can be classified as non-irritant to rabbit skin.

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:

11 August 1992 to 20 November 1992

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Test article: FAT 45155/B
Trade name: ERIONYL ROT HT 3728
Batch No.: HT 3728/TV 1
Purity: 60 - 70 %
Physical properties: powder; dark red
Storage conditions: room temperature; keep dark
Validity: May 15, 1997

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The rabbits were recognized by the international guideline as the recommended test system. Total number of animals are one female and two males.
TEST ANIMALS
- breeder: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- acclimatisation period: at lease 5 days
- Weight at study initiation: 2500-2730 g
- Housing: individually in metal cages
- Feed: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: fresh water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): a 12 hrs light cycle day

Vehicle:

water

Controls:

other: The right eye remained untreated and was used as the control.

Amount / concentration applied:

The application volume was 0.1 ml (91 mg) per animal.

Duration of treatment / exposure:

0.1 ml (91 mg) of FAT 45155/B was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.

Observation period (in vivo):

viability/mortality: Daily;
ocular reaction: ocular reactions were evaluated 1, 24, 48 and 72 hours after the instillation of test substance
body weight: at start and on days 3 and 7

Number of animals or in vitro replicates:

one female and two males

Details on study design:

The ocular reactions were evaluation 1, 24, 48 and 72 hours after the instillation of test substance according to the OECD scoring system. A slit-lamp was used to facilitate the evaluation. The irritation/corrosive potency of test substance was classified.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

1.11

Max. score:

3

Reversibility:

fully reversible within: 7 d

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

No irritation or corrosion was observed.

Other effects:

The eye reactions observed were reversible until the end of the observation period on day 7.

Individual eye score:

Animal No.	Time point	Corneal opacity	Iris	Conjunctiva
				Redness	Chemosis
1	After 24 h	0	0	1	0
2		0	0	1	1
3		0	0	2	1
1	After 48 h	0	0	1	0
2		0	0	1	0
3		0	0	1	0
1	After 72 h	0	0	1	0
2		0	0	1	0
3		0	0	1	0

 

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 45155/B is considered as non-irritant to rabbit eye.

Executive summary:

A GLP-compliant study was performed to access the primary eye irritation potential of FAT 45155/B. Two males and one female were exposed a single dose of test substance (0.1 ml or 91 mg per animal) placed in the eyes of rabbits. The reaction was assessed at 1, 24, 48 and 72 h intervals after administration. Under the experimental conditions employed the test substance induced reactions of the iris and conjunctiva when instilled into the conjunction sac of albino rabbits' eyes. The mean values of the readings 24 to 72 h after instillation for Cornea and Iris was ‘0’ while for redness and chemosis was 1.11 and 0.22, respectively, which are below the threshold of significance. The eye reactions observed were reversible until the end of the observation period on day 7. Based on the study result of this test, FAT 45155/B is considered as non-irritant to rabbit eye.

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 access the primary skin irritation potential when single doses of FAT 45155/B are placed on the skin of New Zealand White rabbits. The study was carried out according to OECD guideline 404. No edema formation was observed during an observation period of 7 days. The application area was red stained up to the reading of 24 hours animals No. 420 and 408 and up to the reading of 48 hours in animal No. 534. Therefore, the evaluation of a possible slight erythema formation was impeded for animal No. 534. The mean values of the recordings 48 to 72 hours after application taken for animals No. 420 and 408 are score zero. Based on the study results, FAT 45155/B can be classified as non-irritant to rabbit skin.

 

Eye Irritation:

A GLP-compliant study was performed to access the primary eye irritation potential of FAT 45155/B. Two males and one female were exposed a single dose of test substance (0.1 ml or 91 mg per animal) placed in the eyes of rabbits. The reaction was assessed at 1, 24, 48 and 72 h intervals after administration. The mean values of the readings 24 to 72 h after instillation for Cornea and Iris was ‘0’ while for redness and chemosis was 1.11 and 0.22 respectively which are below the threshold of significance. The eye reactions observed were reversible until the end of the observation period on day 7. Based on the study result of this test, FAT 45155/B is considered as non-irritant to rabbit eye.

Justification for classification or non-classification

Based on the findings in the skin and eye irritation study, the test substance 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 as well eyes.