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EC number: 216-381-3 | CAS number: 1570-64-5
Skin sensitisation
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:
- 1 982
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
- 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
Constituent 1
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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