2,7-NAPHTHALENEDISULFONIC ACID 5-[[4-CHLORO-6-(ETHYLPHENYLAMINO)-1,3,5-TRIAZIN-2-YL]AMINO]-3-[[5-[(2,3-DIBROMO-1-OXOPROPYL)AMINO]-2-SULFOPHENYL]AZO]-4-HYDROXY-,SODIUM SALT

Endpoint summary

Description of key information

A LD50 of >2000mg/kg bw was observed in both the acute oral as acute dermal toxicity study. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd., Animal production, 4332 Stein / Switzerland
- Weight at study initiation: 184-243g
- Fasting period before study: overnight
- Housing: 5 animals per cage, segregated by sex in Macrolon cages type 4, with standard soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Volume applied: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days. Signs and symptoms: daily for 14 days. Body weight: immediately before administration and on days 7 and 14.
- Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. Additionally, respiratory sounds were recorded in one male. The animals recovered within 3 days.

Gross pathology:

No deviations from normal morphology were found in all animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

In a GLP compliant oral toxicity study, performed according to OECD guideline 401, Tif: RAI f (SPF) rats (5/sex) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period. Mortality did not occur. Piloerection, hunched posture and dyspnea were seen. In one animal respiratory sound were recorded. However, all animals recovered in 3 days. Furthermore, necropsy did not reveal any significant abnormality. Based on these observations, the acute oral toxicity of the test substance in rats of both sexes observed for a period of 14 days was greater than 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP compliant guideline study, klimisch 1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd., Animal production, 4332 Stein / Switzerland
- Weight at study initiation: 213-260g
- Housing: individually in Macrolon cages type 3, with standard soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

- Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- The test substance (4mL/kg bw) was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic band. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days, Signs and symptoms: daily for 14 days, Body weight: immediately before administration and on days 7 and 14.
- Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No symptoms were observed.

Gross pathology:

No deviations from normal morphology were found.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Tif: RAI f (SPF) rats (5/sex) were administered the test substance (2000 mg/kg bw). The test substance was dissolved in water, applied on the skin and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14 -day observation period followed. No mortality, no clinical signs, and no abnormalities were found on necropsy. Therefore, the toxicity of the test substance was estimated to be >2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP compliant guideline study, klimisch 1

Additional information

Acute oral toxicity:

In a GLP compliant oral toxicity study, performed according to OECD guideline 401, Tif: RAI f (SPF) rats (5/sex) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period (Ciba-Geigy 1994). Mortality did not occur. Piloerection, hunched posture and dyspnea were seen. In one animal respiratory sound were recorded. However, all animals recovered in 3 days. Furthermore, necropsy did not reveal any significant abnormality. Based on these observations, the acute oral toxicity of the test substance in rats of both sexes observed for a period of 14 days was greater than 2000 mg/kg bw.

Acute dermal toxicity:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Tif: RAI f (SPF) rats(5/sex) were administered the test substance (2000 mg/kg bw) (Ciba-Geigy 1994). The test substance was dissolved in water, applied on the skin and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14 -day observation period followed. No mortality, no clinical signs, and no abnormalities were found on necropsy. Therefore, the toxicity of the test substance was estimated to be >2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Only study available

Justification for selection of acute toxicity – dermal endpoint
Only study available

Justification for classification or non-classification

Based on the observed LD50 of >2000 mg/kg bw in the acute oral and dermal toxicity study, the test substance does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.