4-nitrotoluene-2-sulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld (Germany)
- Age at study initiation: Young adult animals (male approx. 8 weeks, female approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: doubly distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10 %

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: other: other: No systemic clinical signs were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Any other information on results incl. tables

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	male	female
Administration:	1	1
No. of animals:	5	5
Mortality (animals):	No mortality	No mortality

Applicant's summary and conclusion

Interpretation of results:

other: not classified as harnful/toxic according to the CLP Regulation EC No.1272/2008

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of test item (as suspension in doubly distilled water) to the clipped skin and covered by semi occlusive dressing for 24 hours. No mortality occurred.
Under the conditions of this study the median lethal dose (LD50) of test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.