6,8-dianilinonaphthalene-1-sulphonic acid

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,8-dianilinonaphthalene-1-sulphonic acid

EC Number:

204-970-8

EC Name:

6,8-dianilinonaphthalene-1-sulphonic acid

Cas Number:

129-93-1

Molecular formula:

C22H18N2O3S

IUPAC Name:

6,8-bis(phenylamino)naphthalene-1-sulfonic acid

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: approximately five to eight weeks
- Weight at study initiation: males 142 - 159g, females 132 - 146g
- Fasting period before study: overnight before dosing and for approximately two hours after dosing
- Housing: in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.
- Water (e.g. ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 47 - 76
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- - Deaths and overt signs of toxicity: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- - Bodyweight: on the day of treatment and on days 7 and 14
- Necropsy of survivors performed: yes, it consists of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

male: 0 of 5
female 0 of 5

Clinical signs:

other: diuresis and hunched posture (during the day of dosing)

Gross pathology:

no abnormal findings

Other findings:

no other findings reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

/ consequently classification according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT not warrantable

Conclusions:

LD50: >2000 mg/kg bw

Executive summary:

The test item was tested for acute oral toxicity according to OECD guideline 401. 5 mals and 5 female Sprague-Dawley strain rats were dosed once by gavage with a dose level of 2000 mg/kg bw. No mortality was observed. Therefore, the LD50 of the test material is greater than 2000 mg/kg bw.