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Diss Factsheets

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:
29 April 1996 to 27 June 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
In-vivo data sufficient therefore no additional testing required.

Test material

Constituent 1
Chemical structure
Reference substance name:
4,7-dimethyloct-6-en-3-one
EC Number:
219-845-3
EC Name:
4,7-dimethyloct-6-en-3-one
Cas Number:
2550-11-0
Molecular formula:
C10H18O
IUPAC Name:
4,7-dimethyloct-6-en-3-one
Test material form:
liquid
Specific details on test material used for the study:
Identification: Dimethyl octenone
Description: Colorless liquid
Batch Number: 255476
Purity: 96.3%

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalyan spotted
Sex:
female
Details on test animals and environmental conditions:
Animals were housed individually in cages with standard softwood bedding. Standard pelleted food and water were available ad libitum.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
other: ethanol; 1:1 mixture of Freund's Complete Adjuvant and physiological saline; unchanged (no vehicle)
Concentration / amount:
5% for intradermal injections and 100% for epidermal applications
Day(s)/duration:
Day one for intradermal injections; Day 8 for epidermal applications for 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
15%
Day(s)/duration:
1 day
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 treated animals; 10 control animals
Details on study design:
A Magnusson-Kligman guinea pig maximization test was conducted on 20 female guinea pigs. The animals were induced intradermally at 5%, then epidermally at 100% one week later. After two weeks, the animals were challenged with 15% Dimethyl Octenone. The vehicle was ethanol.
Dimethyl Octenone did not induce skin sensitization in any of the guinea pigs.
Challenge controls:
For validation of sensitivity of the Maximization - Test of B. Magnusson and A.M. Kligman (1969) as well as the sensitivity of the test system used, a known moderate sensitizer was selected as a positive control. This was performed in accordance with the recommendation of the OECD for testing of chemicals number 406 "Skin Sensitization Test", adopted by the council on July 17, 1992.
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole and alpha-hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No toxic symptoms, no deaths
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No toxic symptoms, no deaths
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 15% in ethanol. No skin reactions were observed in the control group.
Executive summary:

The purpose of this skin sensitizing study was to assess the possible allergenic potential of DIMETHYL OCTENONE to albino guinea pigs. The maximization-test of B. Magnusson and A.M. Kligman (1969) was used. Twenty female animals of the test group were induced intradermally once in the first week and epidermally once in the second week with DIMETHYL OCTENONE at 5% in ethanol and 100% (undiluted), respectively.

Two weeks after the epidermal induction application the animals were challenged with the vehicle ethanol and the same test substance used for induction at the highest non-irritating concentration of 15% in ethanol.

The animals of the control group were induced with ethanol only and treated once at challenge with ethanol and DIMETHYL OCTENONE at 15% in ethanol.

No toxic symptoms were evident in the guinea pigs of the control group or test group.

No deaths occurred.

Therefore, the test article DIMETHYL OCTENONE applied at a concentration of 15% in ethanol is considered to be a non-sensitizer when used under the described test conditions.