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

Acute Toxicity: oral

Administrative data

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40508/A
- Batch No.: Roe TV 1P
- Storage conditions: below 5°C
- Expiration date: December 1997

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.