4-mesyl-2-nitrotoluene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 September - 10 October 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

430-550-0

EC Name:

-

Cas Number:

1671-49-4

Molecular formula:

C8H9NO4S

IUPAC Name:

4-methanesulfonyl-1-methyl-2-nitrobenzene

Details on test material:

- Physical state: white powdery solid
- Purity test date: 27 June 1995
- Storage condition of test material: ambient temperature in the dark

Test animals

Species:

rat

Strain:

other: Alpk:APfSD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adults
- Weight at study initiation: 237-270 g (males), 191-218 g (females)
- Fasting period before study: none
- Housing: individually in cages suitable for rats of this strain and weight range expected during the course of the study
- Diet: PCD ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21±2°C
- Humidity: 40-70%
- Air changes: approximately 25-30 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 25 September 1995 To: 10 October 1995

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region (approximately 10 cm x 5 cm shaved the day prior to application) and test substance applied to approximately 1/3 shaved area)
- Type of wrap if used: 4-ply gauze (approximately 7 x 7 cm), covered by plastic film (approximately 7 x 7 cm), held in position using adhesive bandage (approximately 25 x 7.5 cm), secured with two pieces of PVC tape (each approximately 2.5 x 20 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed using clean swabs of cotton wool soaked in clean warm water and dried with clean tissue paper
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 28.4-32.3 mg/cm2 for males and 22.9-26.1 mg/cm2 for females
- For solids, paste formed: yes (with 0.5 mL deionised water)

Duration of exposure:

24 hours

Doses:

2000 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 and weighing: observed prior to study start, once between 1-4 hours after application and once daily thereafter. Bodyweights recorded immediately before dosing (day 1) and on days 3, 4, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

none (limit test, no mortalities)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: limit test, no mortalities

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no treatment-related findings

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 of the test substance is in excess of 2000 mg/kg to male and female rats.

Executive summary:

A group of five male and five female Alpk:APfSD (Wistar-derived) rats received a single dermal application of 2000 mg/kg of the test substance. The rats were assessed daily for the following 14 days for any signs of systemic toxicity and their bodyweights were recorded at intervals throughout the study. At the end of the study all the rats were killed and given a macroscopic examination post mortem. None of the animals died and there were no signs of systemic toxicity or skin irritation. All animals showed an overall weight gain during the study. There were no treatment related abnormalities at post mortem. The acute dermal LD₅₀was in excess of 2000 mg/kg to male and female rats.