4-nitrotoluene-2-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:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-nitrotoluene-2-sulphonic acid

EC Number:

204-445-3

EC Name:

4-nitrotoluene-2-sulphonic acid

Cas Number:

121-03-9

Molecular formula:

C7H7NO5S

IUPAC Name:

2-methyl-5-nitrobenzenesulfonic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River Wiga GmbH , Sulzfeld (Germany)
- Age at study initiation: Yong adult animals (approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20%)
- Fasting period before study: al least 16 hours before administration
- Housing:single housing
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Doubly distilled water

Doses:

2000, 300 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, histopathology, pathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Mortality:

All animals of the 2000 mg/kg test group were found dead within 2 days after the administration.
No mortality occured in the six females administered 300 mg/kg bw.

Clinical signs:

other: other: other: Clinical observation in the 2000 mg/kg bw test group revealed impaired and poor general state, dyspnoea, staggering, salivation, non feces, hemorrhagic urine, piloerection, ataxia and exsiccosis at hour 0 until study day 1 after administrati

Gross pathology:

At necropsy the animals that died in the 2000 mg/kg bw test group showed congestions in the kidneys, bloody content in the stomach, dark gray discoloration of the glandular stomach and loss of epithelial layer, red discoloration of content in the small intestine. There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Any other information on results incl. tables

Mortality
Dose (mg/kg bw):	2000	300	300
Sex:	Female	Female	Female
Administration:	1	1	2
No. of animals:	3	3	3
Mortality (animals):	3	No mortality	No mortality

Applicant's summary and conclusion

Interpretation of results:

other: classified in Category 4 according to the CLP Regulation EC No.1272/2008

Conclusions:

LD50 was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of the test item was evaluated in an experimental study following the OECD Guideline 423 and performed according to the Acute Toxic Class method. Doses of 2000 and 300 mg/kg bw of the test-item (preparation in doubly distilled water) were administered to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner. All animals of the 2000 mg/kg test group were found dead within 2 days after the administration. No mortality occurred in the six females administered 300 mg/kg bw.

Clinical observation in the 2000 mg/kg bw test group revealed impaired and poor general state, dyspnoea, staggering, salivation, non feces, hemorrhagic urine, piloerection, ataxia and exsiccosis at hour 0 until study day 1 after administration. No clinical signs were observed in the first 300 mg/kg administration group. Clinical observation in the second 300 mg/kg test group revealed impaired general state, piloerection and dyspnoea in one animal from hour 1 until hour 2 after administration.
LD50 was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.