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Toxicological information

Skin sensitisation

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Administrative data

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:
other: Data migrated from NONS with permission to refer granted by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC (Maximisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data provided by ECHA and permission to refer granted. No justifications available for why the LLNA was not used.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
No information on test material available. Endpoint study information provided by ECHA from migrated NONS data and specific information not included.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: 5% in water
Concentration / amount:
Induction: Intradermal 5% in water and topical 100% (unchanged).

Day(s)/duration:
Not specified
Adequacy of induction:
not specified
Challenge
Route:
other: Epicutaneous (no futher details)
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Day(s)/duration:
Not specified
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 in the test group and 10 in the negative control.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Not specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None specified
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Maximum concentration not causing irritating effects in the preliminary test: 100%

Signs of irritation during induction: irritation was observed following application of sodium lauryl sulfate and prevented scoring of irritation due to the test substance alone. In the preliminary study no irritation was observed following intradermal injection (5%) or topical application (100%).

No evidence of sensitisation at each challenge was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met