Benzenesulfonic acid, 2-amino-4,5-dichloro-

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: Comparable to guideline study without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Rats are treated by gavage with aqueous preparations of the test substance. Group-wise documentation of clinical signs was performed over the 14-day study period. Body weight was determined before the start of the study for determination of dose.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4-Dichloroaniline-6-sulfonic acid

EC Number:

700-413-2

Cas Number:

6331-96-0

Molecular formula:

C6 H5 Cl2 N O3 S

IUPAC Name:

3,4-Dichloroaniline-6-sulfonic acid

Details on test material:

.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Dr. Thomae GmbH, Biberach, Frg.- Age at study initiation: no data- Weight at study initiation: animal weights were ± 20 g of the average weight- Fasting period before study: 16 hours before administration, no feed was provided. Water was available ad libitum.- Housing: 5 animals/cage in stainless steel wire mesh cages, Type DK-III (Becker & Co., Castop-Rauxel, Frg).- Diet: Kliba Labordiaet 343, Klingenthalmuehle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum- Water: tap water; ad libitum- Acclimation period: at least 1 wk.ENVIRONMENTAL CONDITIONS- Temperature (°C): 20-24- Humidity (%): 30-70- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

[aqueous (0.5%)]

Details on oral exposure:

VEHICLE- Concentration in vehicle: 50%- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.- Lot/batch no. (if required): no data- Purity: no dataMAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.

Doses:

5000 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: several time of day of administration, at least once each workday. Check of moribund and dead animals twice each workday and once on holidays.- Frequency of weighing: beginning of test, 7 and 13 days after administration.- 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:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1% significance level.

Mortality:

None of the animals died.

Clinical signs:

other: No clinical signs of toxicity were noticed within the 14 day observation window before sacrifice.

Gross pathology:

No abnormality was detected.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU