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Administrative data

Description of key information

It has been shown that the test substance was not a skin sensitizer in a guinea pig maximization test. In this study, intradermal injection of this chemical at 0.1 % and topical application at 500 mg were performed as an induction, and topical application of this chemical undiluted at 500 mg as challenge did not induce any response.

Allergic patch test in human also showed that this chemical was not a skin sensitizer. The test was performed with 2 days occlusion and 3 readings (usually on day 2, 3 and 4 - 6). The chemical was applied at 1.0 % to 173 patients, that were suspected occupational dermatoses. No allergic reaction was observed.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1996
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study was conducted before implementation of LLNA-method
Species:
guinea pig
Strain:
Dunkin-Hartley
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.1 %
Day(s)/duration:
day 1 / 7 days
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
500 mg
Day(s)/duration:
day 8 / 48 h
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
500 mg
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 12 days
- Control group: treatment with vehicle only
- Site: intradermal injection in the dorsal region between the shoulders, topical application to the same site
- Frequency of applications: day 1 and day 8
- Duration: 12 days
- Concentrations: 0.1 % in vehicle for intradermal injection and 500 mg undiluted test substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24 h
- Exposure period: 24 h
- Control group: treatment with vehicle only
- Concentrations: 500 mg undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after challenge application
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1997
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
Patients are patch tested. Patch testing was performed with 2 days occlusion and 3 readings (usually on day 2, 3 and 4 - 6). Allergic reactions were scored according to ICDRG recommendations, +, ++ and +++ reactions being considered allergic. Irritant reactions were also recorded. Reactions scored as doubtful (?+) or irritant (IR) were classified as irritant.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
study was conducted before implementation of LLNA-method
Species:
other: human
Details on study design:
Patch testing was performed with 2 days occlusion and 3 readings (usually on day 2, 3 and 4 - 6).
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitizing potential was examined in a guinea pig maximization test. On day 1, 0.1 % in paraffin oil or the vehicle was injected intradermally in the dorsal region between the shoulders. On day 7, the same region received a topical application of sodium lauryl sulfate in vaseline in order to induce local irritation. On day 8, topical application of undiluted substance (500 mg) or the vehicle to this same site was performed with an occlusive dressing for 48 hours. After rest period of 12 days, all animals were challenged by a topical application of undiluted substance (500 mg) and the vehicle to the right and the left flank, respectively. This application was held for 24 hours with an occlusive, hypoallergenic dressing. Skin reaction was evaluated approximately 24 and 48 hours after challenge application. The challenge did not induce any response and therefore, the substance is not considered to cause skin sensitization in this test. (Elf Atochem, 1996)

Another test was performed with 2 days occlusion and 3 readings (usually on day 2, 3 and 4 - 6). 1.0 % in petroleum ether was applied to 173 patients, who were suspected occupational dermatoses. No allergic reaction was observed. (Kanerva, 1997)

The Toxic Substances Control Act provides additional literature data. No skin sensitization was observed when the test substance was applied as a 25 % ointment in "Carbowax 1500" to the abraded skin of 10 albino guinea pigs (series of 9 induction-applications followed by challenge-application after a 2 -week rest period). (TSCAT, 1984)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No local reactions were observed in a guinea pig maximization test and the substance showed no allergic reaction in humans. Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.