3'-hydroxyacetophenone

Skin sensitisation

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

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

Test material information

Constituent 1

Reference substance name:

Chlorocresol

IUPAC Name:

Chlorocresol

Constituent 2

Reference substance name:

59-50-7

Cas Number:

59-50-7

IUPAC Name:

59-50-7

Constituent 3

Reference substance name:

Chlorocresol

EC Number:

200-431-6

EC Name:

Chlorocresol

IUPAC Name:

200-431-6

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)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

petrolatum

Induction 2

Concentration / amount:

1%

Challenge

Challenge 1

Route:

other: no data

Vehicle:

petrolatum

Challenge 2

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 chemical

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.