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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
This study was conducted before the OECD guideline for the LLNA study was adopted.

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS

- Diet (e.g. ad libitum): conventional laboratory diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period:minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°c +/- 3°C
- Humidity (%): 30- 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
A provocation test of 30% PCOC in solution caused erythema therefore a further provocation test at 10% and 20% was carried out a week later.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
A provocation test of 30% PCOC in solution caused erythema therefore a further provocation test at 10% and 20% was carried out a week later.
No. of animals per dose:
40
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test chemical
Dose level:
30% PCOC
Clinical observations:
erythema
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 30% PCOC . Clinical observations: erythema .
Reading:
rechallenge
Group:
test chemical
Dose level:
10% PCOC
Clinical observations:
Some animals with erythema
Remarks on result:
other: Reading: rechallenge. Group: test group. Dose level: 10% PCOC. Clinical observations: Some animals with erythema.
Reading:
rechallenge
Group:
negative control
Dose level:
10% PCOC
Clinical observations:
Some animals with erythema
Remarks on result:
other: Reading: rechallenge. Group: negative control. Dose level: 10% PCOC. Clinical observations: Some animals with erythema .
Reading:
rechallenge
Group:
test chemical
Dose level:
20% PCOC
Clinical observations:
Some animals with erythema
Remarks on result:
other: Reading: rechallenge. Group: test group. Dose level: 20% PCOC . Clinical observations: Some animals with erythema.
Reading:
rechallenge
Group:
negative control
Dose level:
20% PCOC
Clinical observations:
Some animals with erythema
Remarks on result:
other: Reading: rechallenge. Group: negative control. Dose level: 20% PCOC. Clinical observations: Some animals with erythema.

Any other information on results incl. tables

The intial challenge of 30% PCOC resulted in erythema in an unacceptable number of animals therefore a further provocation test was carried out of 10% and 20% PCOC on the left and right flank respectively.

After the second provocation test no clear differences between the test group and control group were observed .

Some animals of both groups reacted with erythema (score 1 -2).

Macroscopically none of the reactions were considered to be of an allergic nature.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Based on the results of the Scantox study , 4-chloro-o-cresol is not required to be classified as a sensitiser.
Executive summary:

A guinea pig maximisation test was performed to OECD guidelines using 40 female albino guinea pigs.

The initial provocation test at 30% PCOC caused unacceptable levels of erythema in the animals therefore a further provocation test was performed at 10% and 20% PCOC a week later.

No clear differences were observed between the test group and the control group. No allergic reactions were observed macroscopically.

4-chloro-o-cresol is not classified as a sensitiser.

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