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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Maximization test was performed to evaluate the skin sensitization potency of Geranyl nitrile on human.
GLP compliance:
not specified
Type of study:
other: maximization test
Species:
human
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data
Route:
other: No data
Vehicle:
petrolatum
Concentration / amount:
12% in petrolatum
Route:
other: No data
Vehicle:
petrolatum
Concentration / amount:
12% 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:
12%
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: 12%. No with. + reactions: 0.0. Total no. in groups: 25.0. Clinical observations: not sensitizing.
Interpretation of results:
not sensitising
Conclusions:
According to maximization test,the chemical Geranyl nitrile was found to be non-sensitizing to human volunteers.
Executive summary:

A maximization test was carried out on 25 volunteers to evaluate the skin sensitizing effects of geranyl nitrile. The test chemical tested at a concentration of 12% in petrolatum.

The volunteers failed to elict any sensitization reaction at the given concentration.

Hence,the chemical Geranyl nitrile (CAS No: 5146 -66 -7) considered to be non-sensitizing .

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

Skin sensitization

Skin sensitization behaviour of test compoundGeranyl nitrile (CAS No: 5146 -66 -7) have been summarized by using data available for test chemical, its read across substances and prediction model based estimation.

The skin sensitisation study was conducted byJosé L. Domingo in 1976 on 25 volunteers to evaluate the skin sensitizing effects of geranyl nitrile by a maximization test at a concentration of 12% in petrolatum. The volunteers failed to elicit any sensitization reaction at the given concentration. Hence, the chemical Geranyl nitrile (CAS No: 5146 -66 -7) was considered to be non-sensitizing.

In the study reported by-Germany 2007 skin sensitizing effects were observed for test chemical Geranyl nitrile (CAS No: 5146 -66 -7)in guinea pigs via an open epicutaneous test. In this test guinea pigs were exposed to the test chemical at concentration of 12%. Since the test chemical did not produce any known skin reactions, Geranyl Nitrile is considered as non-sensitizing to guinea pigs.

The prediction model (The Danish (Q) SAR Database 2016) estimated the skin sensitization effects of Geranylnitrile (CAS No: 5146 -66 -7)on guinea pig and human. According to this prediction model, the test chemical failed to induce any cutaneous reaction in guinea pigs and humans.Thus it can be concluded that the substance GERANYL NITRILE has negative skin sensitization effects.

Thus on basis of the available data for target substance as well as available data estimated by prediction model, the test chemical compound Geranyl nitrile (CAS No: 5146 -66 -7)can be classified as non-skin sensitizer.

Migrated from Short description of key information:

The skin sensitisation study was conducted by José L. Domingo in 1976 on 25 volunteers to evaluate the skin sensitizing effects of geranyl nitrile by a maximization test at a concentration of 12% in petrolatum. The volunteers failed to elicit any sensitization reaction at the given concentration. Hence, the chemical Geranyl nitrile (CAS No: 5146 -66 -7) was considered to be non-sensitizing.

Justification for selection of skin sensitisation endpoint:

The skin sensitisation study was conducted by José L. Domingo in 1976 on 25 volunteers to evaluate the skin sensitizing effects of geranyl nitrile by a maximization test at a concentration of 12% in petrolatum. The volunteers failed to elicit any sensitization reaction at the given concentration. Hence, the chemical Geranyl nitrile (CAS No: 5146 -66 -7) was considered to be non-sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The skin sensitization potential of test chemicalGeranyl nitrile (CAS No: 5146 -66 -7)was observed in various studies. From the results obtained from these studies it is concluded that the chemicalGeranyl nitrile (CAS No: 5146 -66 -7)was unable to cause skin sensitization and can be classified as non-skin sensitizer.

Justification for classification or non-classification