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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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.

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