Reaction products of 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid, coupled twice with diazotized 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 to 20 March 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Internal Guideline Hoechst AG

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: -
- Weight at study initiation: 208 to 222 g
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: groups caging
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: -


IN-LIFE DATES: From: 06. Mar To: 20. Mar 1980

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 %
- Amount of vehicle (if gavage): 20 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/clinical signs: al least daily; body weight: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

-

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths

Clinical signs:

other: drowsiness, piloerection, diarrhea within 1 to 3 hours after dosing. Dark bluish discoloration of skin, feces and urine within 3 to 24 hours after dosing. Discolored skin and urine were observed during the entire observation period with decreasing intensi

Gross pathology:

slight bluish discoloration of cutis and subcutis, purple discolored kidneys;

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Criteria used for interpretation of results: Spector, Handbook of Toxicology

Conclusions:

LD50 above 5000 mg/kg bw. No classification required.

Executive summary:

10 female rats were exposed to the test substance via oral gavage at a single concentrations of 5000 mg/kg body weight and observed for 14 days.

No mortality and adverse clinical signs were observed. No effects on body weight and in gross pathology slight bluish discoloration of cutis and subcutis, purple discolored kidneys observed. Drowsiness, piloerection, diarrhea within 1 to 3 hours after dosing. Dark bluish discoloration of skin, feces and urine within 3 to 24 hours after dosing, and discolored skin and urine were observed during the entire observation period with decreasing intensity.

Based on the observation the acute oral medial lethal dose of test substance is determined to be above 5000 mg/kg bw in female rats.