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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid skin sensitisation study was available from 2002 (before REACh came into force) and therefore no additional LLNA test was performed.

Test material

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

In vivo test system

Test animals

Species:
guinea pig
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
water
Concentration / amount:
test substance in 25% doubly distilled water
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
test substance in 25% doubly distilled water
No. of animals per dose:
10
Positive control substance(s):
yes
Remarks:
Alpha-Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25% test substance preparation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25% test substance preparation
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Freund's adjuvant / 90% aqueous NaCl-solution (1 : 1)
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Freund's adjuvant / 90% aqueous NaCl-solution (1 : 1)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
not reported
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
Alpha-Hexylcinnamaldehyde 85%
No. with + reactions:
14
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Remarks:
a separate study is performed twice a year in the laboratory
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Alpha-Hexylcinnamaldehyde 85%
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
not reported
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the evaluation criteria cited under 3.6. the results of this study show that 2.3-Butandiol does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.
Executive summary:

After the intradermal induction intense erythema and swelling were observed at the injection sites of all control group animals and all test group animals at which only Freund's adjuvant/0.9% aqueous NaCI-solution was applied. At the injection sites of a 5% test substance preparation in Freund's adjuvant/0.9% aqueous NaCI-solution intense erythema and swelling were seen in all test group animals. Injections of a 5% test substance preparation in 0.9% aqueous NaCI-solution caused moderate and confluent erythema and swelling in all test group animals. The control group animals, injected with 0.9% aqueous NaCI-solution did not show any skin reaction. A 50% formulation of 0.9% aqueous NaCI-solution with Freund's adjuvant/0.9% aqueous NaCI-solution caused intense erythema and swelling in all control group animals. The epicutaneous induction with a 50% test substance preparation in doubly distilled water led to incrustation, partially open (caused by the intradermal induction) and moderate and confluent erythema with swelling in all test group animals.

The challenge with a 25% test substance preparation in doubly distilled water did not cause any skin reactions neither in control group 1 nor in the test group 24 and 48 hours after removal of the patches. Since no borderline results were observed, a 2nd challenge was not performed. Control group 2, that had been intended for a potential 2nd challenge was not applied and therefore not reported.