4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)thio]phenoxy}benzene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

July - August 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)sulfanyl]phenoxy}benzene

EC Number:

690-654-9

Cas Number:

106310-19-4

Molecular formula:

C15H10F3NSO2

IUPAC Name:

4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)sulfanyl]phenoxy}benzene

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 252-261 g (males), 236 -250 g (females)
- Housing: conventionally in polycarbonate cages and during the test period individually.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21° +- 1.5° C
- Humidity (%): 40-70%
- air exchange rate: at least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: the sample is combined with cellulose and mixed to a paste

Details on dermal exposure:

TEST SITE
- Area of exposure: 30.3 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with soap and water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10.9 - 11.28 mg/cm² (males); 10.2 - 10.81 mg/cm² (females)

Duration of exposure:

24 h

Doses:

1310 mg/kg bw (2000 mg/kg bw mixed with cellulose) is the MTD due to local irritation.

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: at least once a day (clinical observation); before administration, on day 4 and 8 after administration and then weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 310 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1310 mg/kg bw is the limit dose level due to local irritation

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: no systemic effect

Gross pathology:

The pathological examination at the end of the study showed no change, which refer to a test-substance-specific effect.

Other findings:

Local findings:
distinct effects of irritation

Applicant's summary and conclusion

Executive summary:

A single dermal administration of the test substance to male and female rats at the limit-dose 1310 mg/kg (due to local irritation) was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 1310 mg/kg body weight.