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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from publication

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs- GERANYL BUTYRATE
Author:
D.L.J. Opdyke
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology Volume 12, Issues 7–8, December 1974, Pages 889

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Human maximization test of Geranyl butyrate was conducted in 25 volunteers to determine its sensitization potential.
GLP compliance:
not specified
Type of study:
other: Human maximization test

Test material

Constituent 1
Chemical structure
Reference substance name:
Geranyl butyrate
EC Number:
203-381-3
EC Name:
Geranyl butyrate
Cas Number:
106-29-6
Molecular formula:
C14H24O2
IUPAC Name:
geranyl butyrate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Geranyl butyrate
- Molecular formula: C14H24O2
- Molecular weight: 224.342 g/mol
- Smiles: C(=C\COC(CCC)=O)(\CC\C=C(\C)C)C
- InChl): - 1S/C14H24O2/c1-5-7-14(15)16-11-10-13(4)9-6-8-12(2)3/h8,10H,5-7,9,11H2,1-4H3/b13-10+
-Substance type: organic
- Physical state: liquid

In vivo test system

Test animals

Species:
human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
no data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: No data available.
Vehicle:
petrolatum
Concentration / amount:
4% in petrolatum
Challengeopen allclose all
Route:
other: No data available.
Vehicle:
petrolatum
Concentration / amount:
4% in petrolatum
No. of animals per dose:
25 volunteers
Details on study design:
no data
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
4%
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
not sensitizing
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: not sensitizing.

Any other information on results incl. tables

Sensitizing effects were not observed on volunteers.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to maximization test, the chemical Geranyl butyrate (CAS No.106-29-6) was considered to be non-sensitizing to human volunteers.
Executive summary:

Skin sensitization test was conducted on 25 volunteers for test chemical Geranyl butyrate (CAS No.106-29-6) via human maximization test.

 

In this test, the material was tested at a concentration of 4% in petrolatum on 25 volunteers and then skin reactions were observed.

 

The test material failed to induce skin sensitizing effects on 25 volunteers. Hence the test chemicalGeranyl butyrate (CAS No.106-29-6) was considered to be not sensitizing on skin of humans.