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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study, GLP status not known, published in peer reviewed literature, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
The identification of contact allergens by human assay III. The maximisation test: A procedure for screening and rating contact sensitizers
Author:
Kligman AM
Year:
1966
Bibliographic source:
J. Invest. Derm. Vol 47, 393-409

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin sensitisation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
25 healthy adult males were used. Two main procedures were involved; (a) the potential induction of an immune response; (b) a challenge of that response.
Induction: 1.0 mL of undiluted xylene was applied on "Webril" patches (1.5" x 1.5") under an occlusive dressing to the forearm or calf of the subject. There was a total of five 48 hour exposures to exactly the same skin site. For 24 hours before each application 1.0 mL of 5% aqueous sodium lauryl sulphate (irritant) was administered.
Challenge: 0.4 mL of 5% aqueous sodium lauryl sulphate was applied on "Webril" patches (1" x 1") under an occlusive dressing to the back for 1 hour followed by undiluted xylene for 48 hours. The challenge reaction is assessed immediately after removal of the dressing and again 2 days later and the degree of sensitisation classified on a 1-5 scale.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
mixed xylenes
EC Number:
924-522-1
IUPAC Name:
mixed xylenes
Constituent 2
Chemical structure
Reference substance name:
Xylene
EC Number:
215-535-7
EC Name:
Xylene
Cas Number:
1330-20-7
Molecular formula:
C8H10
IUPAC Name:
xylene
Details on test material:
No further details

Method

Type of population:
other: volunteer
Subjects:
25 males (90% were black) aged 18 - 50 years.

Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
A total of five applications of undiluted test material to inflamed skin on the forearm or calf (same site on each occasion, pre-treated with SLS) followed by challenge (100%, 25% mixed xylenes) on the back. An occlusive dressing was applied.

Results and discussion

Clinical signs:
None
Results of examinations:
The sensitisation rate was 0/24 indicating that mixed xylenes was not a skin sensitiser under the conditions of the study.

Any other information on results incl. tables

Mixed xylenes was not a sensitiser under the conditions of the study.

Applicant's summary and conclusion

Conclusions:
The human maximization test devised by Albert Kligman is a highly sensitive detector of skin sensitizing potential. In this assay, xylene was tested at 100% and subjects challenged at 25%. No skin sensitization resulted.
Executive summary:

The skin sensitisation potential of mixed xylenes was investigated in an early human maximisation test employing a total of five applications to inflamed skin on the forearm or calf (same site on each occasion, pre-treated with SLS) followed by challenge (100%, 25% mixed xylenes) on the back. The sensitisation rate was 0/24 indicating that mixed xylenes was not a skin sensitiser under the conditions of the study. The results for more than 80 chemicals are presented in this paper which demonstrates the very considerable predictive sensitivity of ths assay.