Registration Dossier
Registration Dossier
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EC number: 248-890-1 | CAS number: 28188-41-2
Skin sensitisation
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:
- 2 017
- Bibliographic source:
- GESTIS - Substance Database (Information system on hazardous substances of the Benzonitrile ) 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Benzonitrile
- EC Number:
- 202-855-7
- EC Name:
- Benzonitrile
- Cas Number:
- 100-47-0
- Molecular formula:
- C7H5N
- IUPAC Name:
- Benzonitrile
- 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
Constituent 1
- 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 chemical
- 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.
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