Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation

The skin sensitization potential of the given test chemical was assessed in various studies conducted on guinea pigs and humans. Based on the available studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus it cannot be classified as per CLP regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
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
Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
8%
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
Positive control results:
No data available
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In different studies, the given test chemical has been investigated for the dermal sensitization potential to a greater or lesser extent. The studies are based on in-vivo experiments conducted in humans and guinea pigs that have been summarized as below -

 

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.

 

Skin sensitization effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for the test chemical. Based on estimation, the skin sensitization was estimated to be negative on guinea pig and human for the given test chemical. Therefore, the test chemical was considered to be not sensitizing.

 

The estimated result is further supported by a maximization test carried out to assess the dermal sensitization potential of the test chemical in human subjects. In skin sensitization study, 24 volunteers were studied at a test chemical concentration of 10 % in petrolatum. No reaction was observed. Therefore, the given test chemical was considered to be not sensitizing to humans.

The results of the maximization test were supported by a skin sensitization study, 26 volunteers were tested by maximization test at a given test chemical concentration of 2% in petrolatum. No reaction was observed. Therefore, the given test chemical was considered to be not sensitizing to humans.

 

The results from these experimental and estimated studies lead to a possibility of the test chemical being not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for “Skin sensitization”.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The results from these experimental and estimated studies lead to a possibility of the test chemical being not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical cannot be classified for “Skin sensitization”.