Registration Dossier

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: GLP 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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-Nitrotoluene-2-sulphonic acid
- Physical state:solid, beige
- Analytical purity: 80 % pNTSA, < 3 % H2SO4, < 1 % "Disulfon", Water
- Lot/batch No.:090330
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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 (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): 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:
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. Additionally reduced feces were observed in this animal on study day 1 after administration.
Body weight:
The mean body weight of the 300 mg/kg bw test groups increased throughout the study period within the normal range.
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