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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from review article or handbook

Data source

Reference
Reference Type:
review article or handbook
Title:
p-Chloro-m-cresol [MAK Value Documentation, 1991]
Author:
MAK
Year:
1991
Bibliographic source:
p-Chloro-m-cresol [MAK Value Documentation, 1991]-Occupational Toxicants, Vol. 2 (1991)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A skin test was carried out in 671 patients with eczema in 6 Danish out-patient clinics for test chemical p-Chloro-m-cresol (PCMC).
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Skin sensitisation test has been carried out to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): p-Chloro-m-cresol (PCMC)
- Molecular formula: C7H7ClO
- Molecular weight: 142.5843 g/mole
- Substance type: Organic
- Physical state: solid
- InChI: 1S/C7H7ClO/c1-5-4-6(9)2-3-7(5)8/h2-4,9H,1H3
- Smiles: c1(c(ccc(c1)O)Cl)C

In vivo test system

Test animals

Species:
human
Strain:
other: not applicable
Sex:
male
Details on test animals and environmental conditions:
671 patients with eczema in 6 Danish out-patient clinics

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
petrolatum
Concentration / amount:
1%
Challengeopen allclose all
Route:
other: no data
Vehicle:
petrolatum
Concentration / amount:
1%
No. of animals per dose:
671 patients
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
671
Clinical observations:
not sensitizing
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 671.0. Clinical observations: not sensitizing.

Any other information on results incl. tables

No sensitization was observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
The extensive skin tests carried out with p-Chloro-m-cresol (PCMC) (CAS No: 59-50-7) PCMC (1 % in petrolatum) on 671 patients with eczema in 6 Danish out-patient clinics was observed to be negative. Hence p-Chloro-m-cresol (PCMC) (CAS No: 59-50-7) PCMC (1 % in petrolatum) can be considered as non-sensitizing on humans.
Executive summary:

Skin sensitization test was carried out on 671 patients with eczema in 6 Danish out-patient clinics to assess the skin sensitization potential of test chemicalp-Chloro-m-cresol (PCMC) (CAS No: 59-50-7).

 

The patients (men) were treated with 1% of PCMC and observed for skin reactions.

 

In spite of the fact that the selected patient collective included cases with severe irritation and skin lesions, no positive reactions were observed. Hence the test substance p-Chloro-m-cresol (PCMC) (CAS No: 59-50-7)was considered to be non-sensitizing on humans.