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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
Study period:
From March 9, 1983 to April 2, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study (GPMT) was conducted prior to the implementation of the LLNA method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Remarks:
Mouse, CBA/J strain, inbred, SPF-Quality.
Sex:
male
Details on test animals and environmental conditions:
Main test is conducted with 15 young male SPF bred albino guinea pigs (body weight 200-400g).

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
10%
Day(s)/duration:
24 and 48h
Route:
intradermal
Vehicle:
other: Mixture of FCA and Propylene Glycol (1:1)
Concentration / amount:
10%
Day(s)/duration:
24 and 48 h
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10%
Challenge controls:
Upon the challenge treatment - with 10% dilution- one out of ten test animals showed very slight erythema immediately after removal of the dressing.
At the same time, one of the five control animals reacted positively.
After 24 and 48 h, none of the test-or control animals showed erythema reactions.
Positive control substance(s):
yes

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
5
Clinical observations:
very slight erythema
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Very slight erythema
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Since none of the test animals showed erythema reactions in the challenge test at the 24 hours reading, it is concluded that the test substance did not induce delayed contact hypersensitivity in any of the guinea pigs under the conditions of the test.
Executive summary:

The test substance SINODOR was examined for possible senitization potential by a maximisation test in guinea pigs.

From the reaction to the challenge treatment with a 10% dilution of the test substance in vaseline, it was concluded that the test substance did not induce dealyed contact hypersensitivity in guinea pigs under the conditions of the test.