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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Skin sensitisation study for CAS no: 20780-49-8
Author:
Edited by D.L.J Opydke
Year:
1980
Bibliographic source:
Food and Cosmetics Toxicology FCTOD7. 18,673,1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
A maximization test of the given test chemical was carried out on 28 volunteers.
GLP compliance:
no
Type of study:
other: maximization test
Justification for non-LLNA method:
No data available

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyl-1-octyl acetate
EC Number:
244-034-6
EC Name:
3,7-dimethyl-1-octyl acetate
Cas Number:
20780-49-8
Molecular formula:
C12H24O2
IUPAC Name:
3,7-dimethyl-1-octyl acetate
Details on test material:
- Name of test material (as cited in study report): 3,7-dimethyloctanyl acetate
- Molecular formula : C12H24O2
- Molecular weight : 200.32 g/mol
- Substance type: Organic
- Physical state:Liquid
Specific details on test material used for the study:
Name of test material (as cited in study report): Dihydrocitronellyl acetate
IUPAC name: 3,7-dimethyl-1-octyl acetate
Molecular formula: C12H24O2
Molecular weight: 200.32 g/mol
Smiles notation: C([C@@H](CCOC(C)=O)C)CCC(C)C
InChl: 1S/C12H24O2/c110(2)65711(3)891412(v4)13/h1011H,59H2,14H3
Substance Type: Organic
Physical State: Liquid

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
8%
Challenge
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
8%
No. of animals per dose:
28 volunteers
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
28
Clinical observations:
No skin sensitization reaction was observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
The given test chemical was considered to be non sensitizing to human skin.
Executive summary:

A maximization test was carried out on 28 volunteers to assess the skin sensitization potential of the test chemical. The given test material was tested at a concentration of 8% in petrolatum and produced no sensitization reactions. Hence, the given test chemical was considered to be not sensitizing to human skin.