Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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 athourative database

Data source

Reference
Reference Type:
other: authorative database
Title:
Skin sensitization potential of Benzonitrile
Author:
IFA (GESTIS)
Year:
2017
Bibliographic source:
GESTIS - Substance Database (Information system on hazardous substances of the Benzonitrile ) 2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate skin sensitization potential of Benzonitrile on 35 human volunteers
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
IUPAC name: Benzonitrile
Molecular formula :C7H5N
Molecular weight :103.123 g/mol
Substance type: organic
Physical state: Colorless liquid
InChI :1S/C7H5N/c8-6-7-4-2-1-3-5-7/h1-5H
Smiles:c1(ccccc1)C#N



Specific details on test material used for the study:
IUPAC name: Benzonitrile
Molecular formula :C7H5N
Molecular weight :103.123 g/mol
Substance type: organic
Physical state: Colorless liquid
InChI :1S/C7H5N/c8-6-7-4-2-1-3-5-7/h1-5H
Smiles:c1(ccccc1)C#N


In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
35 human volunteers were used

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Day(s)/duration:
48 hrs
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2%
Day(s)/duration:
48hrs
Adequacy of challenge:
not specified
No. of animals per dose:
35 human volunteers
Details on study design:
A. INDUCTION EXPOSURE
- No. of exposures: No data
- Exposure period:48 hrs
- Test groups: 35 human volunteers
- Control group: No data
- Site: no data
- Frequency of applications: No data
- Duration: 48 hrs
- Concentrations: 2%

B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Day(s) of challenge: 48 hrs
- Exposure period: 48 hrs
- Test groups: 35 human volunteers
- Control group: No data
- Site: No data
- Concentrations: 2%
- Evaluation (hr after challenge): 48 hrs
Challenge controls:
Not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
2% in petrolatum
No. with + reactions:
0
Total no. in group:
35
Clinical observations:
No noticeable skin reaction were observed
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
No noticeable skin reaction were observed

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
Benzonitrile when applied on 35 human volunteers in concentration 2% in petrolatum for 48 hrs produced no noticeable skin reaction. Hence, Benzonitrile was considered to be not sensitizing to human skin.
Executive summary:

Benzonitrile was used as a test material to evaluate skin sensitization potential on 35 human volunteers.The test material when applied in the concentration 2% in petrolatum for 48 hrs in occlusive patch test produced no noticeable skin reactions. Hence, Benzonitrile was considered to be not sensitizing to human skin.