Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate

Endpoint summary

Description of key information

Skin Irritation:

Primary skin irritation study in rabbits with FAT 20075/B was conducted according to OECD guideline 404 and EU method B.4 in accordance with GLP. The purpose of this primary skin irritation study was to assess the possible irritation potential when single doses of test article were placed on dorsal skin of each of three young adult New Zealand rabbits (1 male and 2 female). On test Day 1, total 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The duration of treatment was 4 h. There were no clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. FAT 20075/B showed a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.11 edema. Reversible red staining by the test article of the treated skin was observed. The body weight gain of all rabbits was within the normal range of variability. Based on these observations and on the referred classification criteria, FAT 20075/B is classified as "non irritating" to rabbit skin.

Eye Irritation:

Primary eye irritation study in rabbits with FAT 20075/B was conducted according to OECD 405 guideline and in accordance with GLP in 1995. The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult (1 male and 2 female) New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of the animals was within the normal range of variability. Swelling of the conjunctivae was reversible after seven days. Watery discharge was evident in all animals but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days. Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. No corrosion was observed at any of the measuring intervals. Based on the study results FAT 20075/B is classified as "not irritating" to the rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 October 1995 to 26 October 1995

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

Qualifier:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
1.56
- Expiration date of the lot/batch:
June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In refrigerator (ca. 4 °C)protected from sunlight.
- Stability under storage conditions:
stable at storage conditions
- Stability of the test substance in the water:
not specified; excluded from the Statement of Compliance

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
- Age at study initiation: 15 weeks
- Weight at study initiation: male: 2.6 kg; females: 2.8 - 3.0 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: Pelleted standard Kliba 341, Batch 91/95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 4 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70 % (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux) /12 hours dark

IN LIFE PHASE: 23 October 1995 to 26 October 1995

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with bi-distilled water.

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48 and 72 h after removal of dressing, gauze patch and test article.

Number of animals:

1 male
2 females

Details on study design:

TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm)
- % coverage: 3.0 cm x 3.0 cm patch of surgical gauze
- Type of wrap if used: Elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lukewarm tap water
- Time after start of exposure: after 4 h

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

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

Other effects:

None.

VIABILITY / MORTALITY AND CLINICAL SIGNS

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred

 

IRRITATION

FAT 20075/B showed a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.11 edema.

 

COLORATION

Reversible red staining by the test article of the treated skin was observed.

 

CORROSION

No irreversible alteration of the treated skin were observed nor were corrosive effects evident on the skin.

 

BODY WEIGHTS

The body weight gain of all rabbits was within the normal range of variability.

 

Skin Irritation Score:

Time period	Animal No.	Sex	Erythema	Edema
24 h	31	Male	0	0
	32	Female	0	1
	33	Female	0	0
48 h	31	Male	0	0
	32	Female	0	0
	33	Female	0	0
72 h	31	Male	0	0
	32	Female	0	0
	33	Female	0	0

 

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20075/B is classified as "non irritating" to rabbit skin.

Executive summary:

Primary skin irritation study in rabbits with FAT 20075/B was conducted according to OECD guideline 404 and EU method B.4 in accordance with GLP. The purpose of this primary skin irritation study was to assess the possible irritation potential when single doses of test article were placed on dorsal skin of each of three young adult New Zealand rabbits (1 male and 2 female). The test article was moistened with bi-distilled water before application. Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was examined once, 1 day prior to test article administration. Only those animals with no signs of skin injury or irritation were used in the test.

On test Day 1, total 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test article was applied in such a position as to preclude oral ingestion after removal of the dressing.

The duration of treatment was 4 h. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time. The skin reaction was assessed at approximately 1, 24, 48 and 72 h after the removal of the dressing, gauze patch and test article.

There were no clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. FAT 20'075/B showed a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 h) consisted of grade 0.00 erythema and grade 0.11 edema. Reversible red staining by the test article of the treated skin was observed. The body weight gain of all rabbits was within the normal range of variability.

Based on these observations and on the referred classification criteria, FAT 20075/B is classified as "non irritating" 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:

30 October 1995 to 06 November 1995

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:

according to guideline

Guideline:

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

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
1.56
- Expiration date of the lot/batch:
June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
In refrigerator (ca. 4 °C) protected from sunlight
- Stability under storage conditions:
stable at storage conditions

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Stolzenseeweg 32-36 D-88353 Kisslegg
- Age at study initiation: 13 weeks
- Weight at study initiation: male : 2.2 kg; females: 2.2 - 2.3 kg
- Housing: Individually in stainless steel cages with an automatic cleaning system, equipped with feed hoppers, drinking water bowls and wood for gnawing.
- Diet: Pelleted standard Kliba 341, Batch no. 91/95 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 Lux)/12 hours dark

IN-LIFE DATES: From: October 25, 1995 To: December 12, 1995

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

1 male and 2 females

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

24 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

48 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

3 animal

Time point:

72 h

Score:

1

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:

0.77

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

No corrosion of the cornea was observed at any of the reading times.

Other effects:

- Swelling of the conjunctivae was reversible after seven days.
- Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.
- Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.

VIABILITY / MORTALITY AND CLINICAL SIGNS

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

 

IRRITATION

FAT 20'075/B showed a primary irritation score of: 1.11, when applied to the conjunctival sac of the rabbit eye. Slight-to-moderate swelling of the conjunctivae was noted in all animals but was reversible after seven days. Slight-to-moderate watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days.

 

COLORATION

Light red or red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days.

 

CORROSION

No corrosion of the cornea was observed at any of the reading times.

 

BODY WEIGHTS

The body weight of the animals was within the normal range of variability.

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20075/B is classified as "not irritating" to the rabbit eye.

Executive summary:

Primary eye irritation study in rabbits with FAT 20075/B was conducted according to OECD 405 guideline and in accordance with GLP in 1995. The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult (1 male and 2 female) New Zealand rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of figures. No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred. The body weight of the animals was within the normal range of variability. It was found to be 1.11, when applied to the conjunctival sac of the rabbit eye. Swelling of the conjunctivae was reversible after seven days. Watery discharge was evident in all animals, but was reversible in one animal after 72 hours and in two animals after seven days. Hyperemia of the scleral blood vessels was reversible in all animals after seven days. Red staining of the cornea, sclera and conjunctivae by the test article was observed. These findings were reversible after seven days. No corrosion was observed at any of the measuring intervals. Based on the study results FAT 20075/B is classified as "not irritating" to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings in the skin and eye irritation study, Acid Red 252 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 as eyes.