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

Endpoint summary

Description of key information

Skin irritation/corrosion

A single dermal administration of the test substance for 4 hours to rabbits according to OECD TG 404 caused significant irritant effects. In addition to the marked erytherna and oedema formation, on the exposed skin area a white squamous coat was observed, the skin was hardened and the epidermis was destroyed in all three animals. Signs did not prove to be reversible up to day 14.

Eye irritation

Materials which have demonstrated definite corrosive or severer skin irritancy in a dermal study need not be further tested for eye irritancy, it being presurned that such substances will produce similarly severe effects on the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - May 1993

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Housing: indivudually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C +- 1.5 °C
- Humidity (%): 40% - 70%
- Photoperiod (hrs dark / hrs light): 12
- Air changes (per hr): 12 - 15 times

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The cotralateral skin area not treated with the test substance served as control

Amount / concentration applied:

500 µg

Duration of treatment / exposure:

4 h

Observation period:

Until the changes observed have completely subsided, however for not more than 14 days after application

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
60 minutes, 24, 48, 72 hours, 7 and 14 days after patch removal

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 14d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14d

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Executive summary:

A single dermal administration of the test substance for 4 hours to rabbits according to OECD TG 404 caused significant irritant effects. In addition to the marked erytherna and oedema formation, on the exposed skin area a white squarnous coat was observed, the skin was hardened and the epiderrnis was destroyed in all three anirnals. Signs did not prove to be reversible up to day 14.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the study results for skin irritation/corrosion a classification in Category 1 (H 314: Causes severe skin burns and eye damage) according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.

Although a skin corrosive substance is also classified for serious eye damage which is indicated in the hazard statement for skin corrosion (see above), also a classification Category 1 Eye Dam. is required and has to be addressed in the safety data sheet, the hazard statement H318 ‘Causes serious eye damage’ is not indicated on the label because of redundancy.