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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP/GCP study (no data on test substance purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Induction: Ten repeated applications of test substance to the same site (24 h application, 24 rest period between two applications).
Challenge: A single application on the treated and at naïve site. Reading of skin alterations.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 55 (initially 56, but 1 subject did not complete the study)
- Sex: male/female
- Age: 19 - 65
Controls:
no
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 2.54 x 2.54 cm Webril pads (cotton), held in place with Dermicel tape
- Volume applied: 0.15 mL
- Testing/scoring schedule:
The test substance was applied to backs of volunteers for 24h using patches followed by a 24-h (when applied on Monday and Wednesday) or a 48-h rest period (when applied on Friday). The procedure was repeated for a total of 10 applications. After the last application, a 14-day rest period followed. A single application to the original and at naïve site was used for challenge. Scoring was done 24 and 48 h after patch removal.
- Removal of test substance: no

EXAMINATIONS
- Grading/Scoring system:
0 = no visible reaction
1+ = mild erythema
2+ = well-defined erythema
3+ = erythema and edema
4+ = erythema and edema with vesiculation and ulceration

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: 55
- Number of subjects with equivocal reactions: none
- Number of subjects with irritating reactions: none

Applicant's summary and conclusion

Conclusions:
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.