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Administrative data

Description of key information

Skin sensitization: Key study: Test method similar to OECD 406. Test item was determined not to be a skin sensitizant in a guinea-pig maximization test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
topical application only
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed prior to the REACH Regulation. Published data.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source: Shiono Koryo Kaisha, Ltd.
- Purity: 97.9%
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 350-400 g
Route:
epicutaneous, semiocclusive
Vehicle:
petrolatum
Concentration / amount:
10%
Day(s)/duration:
48h (three times a week per two weeks)
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.1%
Day(s)/duration:
48h
Adequacy of challenge:
not specified
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
10%
Day(s)/duration:
48h
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: No data.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6
- Exposure period: 48 hours
- Test groups: 1
- Control group: Not specified
- Site: Nape
- Frequency of applications: 3 times a week
- Duration: 2 weeks
- Concentrations: 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks after the end of the induction procedure.
- Exposure period: 48 hours
- Test groups: 1
- Control group: Not specified
- Site: Flank
- Concentrations: 0.1 and 10%
- Evaluation (hr after challenge): 1, 24, 48 hours and one week after the removal of the test materials.
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
0.1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
72
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Group:
negative control
Remarks on result:
other: Not specified
Reading:
1st reading
Group:
positive control
Remarks on result:
other: Not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Test item was determined not to be a skin sensitizant in a guinea-pig maximization test.
Executive summary:

A guinea-pig maximization test was perform for the evalution of skin sensitization potential of the test item. Ten female Hartley albino guinea pigs (350 to 400 grams) were used. For induction, nape hair was shaved and about 50 mg of the test item at a concentration of 10% in white petrolatum was applied to a round cloth 1.5 cm in diameter on Torii's patch plaster and applied to the napes of the guinea pigs. Dermicel cloth tape, Reston foam pads, and then Dermicel cloth tape were placed over the plaster. The test materials were removed 48 hours after application. This procedure was repeated three times a week for two weeks. Two weeks after the end of the induction procedure, the flanks of the guinea pigs were shaved, and 1% and 0.1 % in white petrolatum were occluded with Finn chambers on Scanpor on the shaved flank areas. Dermicel cloth tape, Reston foam pads and Dermicel cloth tape were applied in the same manner as for induction. The test materials were removed 48 hours after the application. The degree of reaction ,was read at 1, 24, 48 hours and one week after the removal of the test materials. No skin sensitization reaction was observed. Test item was determined not to be a skin sensitizant.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on available data, the substance is not classified for skin sensitization according to the CLP Regulation (EC) no. 1272/2008 .