Registration Dossier
Registration Dossier
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EC number: 203-381-3 | CAS number: 106-29-6
Endpoint summary
Administrative data
Description of key information
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.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- no data
- Route:
- other: No data available.
- Vehicle:
- petrolatum
- Concentration / amount:
- 4% in petrolatum
- 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
- 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.
- 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.
Reference
Sensitizing effects were not observed on volunteers.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
Skin sensitization behaviour of test compoundGeranyl butyrate (CAS No.106-29-6) have been summarized below by using data available for target substance, data from prediction model based estimation and its read across substances.
D.L.J. Opdyke in 1974 performed skin sensitization for test substance Geranyl butyrate (CAS No.106-29-6) on humans via human maximization test. In this test, the Geranyl butyrate 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 chemical Geranyl butyrate (CAS No.106-29-6) was considered to be not sensitizing on skin of humans.
The OECD QSAR toolbox version 3.4 estimated the skin sensitization potential of test chemicalGeranyl butyrate (CAS No.106-29-6)by Buehler test on guinea pigs. According to this prediction model, the test chemical failed to induce skin sensitization in guinea pigs. Thus the test compoundGeranyl butyrate (CAS No.106-29-6)is estimated to be non-sensitizing to skin of guinea pigs.
According to Danish (Q) SAR Database 2016, the sensitization effects were observed for targetGeranyl butyrate (CAS No.106-29-6)in guinea pig and human. Skin sensitization effects were estimated by four different models i.e, Battery, CASE Ultra, Leadscope and SciQSAR used within Danish QSAR database for chemical Geranyl butyrate. Based on estimation No skin sensitization effect were known when test chemical Geranyl butyrate exposed to Guinea Pig and Human.
The skin sensitization study was reported by for similar read across substance D.L.J. Opdyke (1978) Citronellyl isobutyrate (CAS No: 97-98-2). In this study, a maximization test was conducted on25 volunteers for test chemical Citronellyl isobutyrate (CAS No: 97-98-2) to assess its sensitization potential. During the test, 25 volunteers were exposed to test chemical at concentration of 4% in petrolatum and then observations were made for any skin reactions. None of the subject elicited any skin sensitizing reaction. Hence the test chemical Citronellyl isobutyrate (CAS No: 97-98-2) was considered to be not sensitizing on skin of 25 volunteers.
The available data for target substanceGeranyl butyrate (CAS No.106-29-6)and read across substance Citronellyl isobutyrate (CAS No: 97-98-2) suggests that the test chemical substanceGeranyl butyrate (CAS No.106-29-6) is not likely to cause skin sensitization and thus can be classified as non-skin sensitizer.
Migrated from Short description of key information:
D.L.J. Opdyke in 1974 performed skin sensitization for test substance Geranyl butyrate (CAS No.106-29-6) on humans via human maximization test. In this test, the Geranyl butyrate 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 chemical Geranyl butyrate (CAS No.106-29-6) was considered to be not sensitizing on skin of humans.
Justification for selection of skin sensitisation endpoint:
According to maximization test, the chemical Geranyl butyrate (CAS No.106-29-6) was considered to be non-sensitizing to human volunteers.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitization potential of test chemical substanceGeranyl butyrate (CAS No.106-29-6) and its read across substances Citronellyl isobutyrate (CAS No: 97-98-2) were observed in various studies. From the results obtained from these studies it is concluded that the test chemicalGeranyl butyrate (CAS No.106-29-6)was unable to cause skin sensitization and hence can be classified as non-skin sensitizing.
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