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Toxicological information

Skin sensitisation

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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 peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Monographs on Fragrance Raw Materials – Benzonitrile
Author:
D. L. J. Opdyke
Year:
1979
Bibliographic source:
Food and Cosmetics Toxicology ; Volume 17, Supplement, December 1979, Pages 723-725

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A Human maximisation test was carried out in 35 volunteers to determine skin sensitization potential caused by the chemical Benzonitrile (CAS No: 100-47-0)
GLP compliance:
not specified
Type of study:
other: Human maximisation test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzonitrile
EC Number:
202-855-7
EC Name:
Benzonitrile
Cas Number:
100-47-0
Molecular formula:
C7H5N
IUPAC Name:
benzonitrile
Details on test material:
Name - Benzonitrile
InChI - 1S/C7H5N/c8-6-7-4-2-1-3-5-7/h1-5H
Smiles - c1(ccccc1)C#N
- Molecular formula (if other than submission substance):C7H5N
- Molecular weight (if other than submission substance):103.123 g/mole
- Substance type:Organic
Specific details on test material used for the study:
- Name of test material (IUPAC name): - Benzonitrile
- Molecular formula: C7H5N
- Molecular weight: 103.123 g/mol
- Smiles notation: c1(ccccc1)C#N
- InChl: 1S/C7H5N/c8-6-7-4-2-1-3-5-7/h1-5H
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
other: Human
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
2%
Day(s)/duration:
No data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
35
Details on study design:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
2%
No. with + reactions:
0
Total no. in group:
35
Clinical observations:
No signs of skin sensitization were observed.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No signs of skin sensitization were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test material Benzonitrile (CAS No: 100-47-0) was considered to be not sensitizing to the skin of human volunteers.
Executive summary:

A Human maximisation test was carried out in 35 volunteers to determine skin sensitization potential caused by the chemicalBenzonitrile(CAS No: 100-47-0).

 

Each subject was treated with 2% of Benzonitrilei n petrolatum dermally and later observed for any signs of contact allergy.

 

None of the volunteer showed any signs of contact sensitization. Hence the chemicalBenzonitrile(CAS No: 100-47-0) wasconsidered to be not sensitizing to theskin of human volunteers.