4-chloro-o-cresol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Taken from EU Risk Assessment Report - Reviewed by the Danish Environmental Protection Agency. Guideline Study.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-o-cresol

EC Number:

216-381-3

EC Name:

4-chloro-o-cresol

Cas Number:

1570-64-5

Molecular formula:

C7H7ClO

IUPAC Name:

4-chloro-2-methylphenol

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: Individual
- Diet (e.g. ad libitum): Conventional laboratory diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period:24 hours


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other:

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
0.5g of 4-Chloro-o-cresol in 0.1ml of oleum arachidis

Duration of treatment / exposure:

4 hours

Observation period:

Not specified

Number of animals:

Six female rabbits

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk.
- Type of wrap if used: Gauze patch.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 4 hours after start of exposure the residudal test substance was removed using water or an appropriate solvent.

SCORING SYSTEM: Primary Irritation Index

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 4 hours

Score:

ca. 8

Max. score:

8

Reversibility:

not reversible

Applicant's summary and conclusion

Interpretation of results:

other: highly corrosive

Remarks:

Criteria used for interpretation of results: other: Approved clasification and Labelling Guide (Sixth Edition), Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP 4)

Conclusions:

Based on the results from the Scantox study 4-Chloro-o-cresol is classified as highly corrosive.

Executive summary:

In a guideline study 6 female rabbits were dermally exposed to 0.5g PCOC in 0.1ml of oleum arachidis. The test site was covered for a period of 4 hours following which the residual test substance was removed by washing.

A primary irritation index of 8.0 was calculated. Immediately after removal of the test substance the skin was white, a sign of initial necrosis.