Reaction products of diazotised 5-aminonaphthalene-1-sulfonic acid, coupled with diazotised 1-naphthylamine and 8-anilinonaphthalene-1-sulphonic acid, potassium sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read across from analogous substance

Adequacy of study:

key study

Study period:

From August 15 to August 29, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black BD:1-Similar Substance 01 (A)

Molecular formula:

N/A

IUPAC Name:

Acid Black BD:1-Similar Substance 01 (A)

Test material form:

not specified

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borochen
- Age at study initiation: ♂ 7 weeks; ♀ 11 weeks
- Weight at study initiation: ♂ 171 g (mean); ♀ 174 g (mean)
- Fasting period before study: from 16 hours before, to 4 hours after the administration
- Housing: 5 animals per cages (Makrolon cages type III)
- Diet (e.g. ad libitum): Fixed - formula with Altromin®1324 (Altromin GmbH)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/ 10 hours darkness (light from 6:00 to 18:00)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 ml/kg bw

Doses:

Single dose tested: 2000 mg/kg bw

No. of animals per sex per dose:

5 animal per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Twice a day during the weekdays; once a day during the Weekend and public holidays
- Frequency of weighing: Before the administration, after 1 week from the administration and atthe end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred

Clinical signs:

other: No clinical signs observed

Gross pathology:

No evidences observed during the pathological analysis

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 (oral) > 2000 mg/kg bw

Executive summary:

Method

The test has been conducted according to the OECD Guidelines 401 and in compliance with the CLP Regulation. During the test has been administrated to the rats a single dose (2000 mg/kg bw) as the limit test described in the OECD 401.

Observations

No death occurs and non clinical or pathological signs have been observed, the substance is considered as not toxic via oral route in the test conditions.

Conclusion

The acute oral median lethal dose (LD50) of the test material in the test conditions, was estimated as being greater than 2000 mg/kg bodyweight.