4-aminobenzonitrile

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003-08-5 to 2004-09-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: SPL Standard Test Method 595.122

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

no

Remarks:

Study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme. No formal claim of GLP compliance was made for this study.

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

4-aminobenzonitrile

EC Number:

212-850-1

EC Name:

4-aminobenzonitrile

Cas Number:

873-74-5

Molecular formula:

C7H6N2

IUPAC Name:

4-aminobenzonitrile

Details on test material:

- Name of test material (as cited in study report): 4-aminobenzonitrile
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data

- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data

Specific details on test material used for the study:

No further data available

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

not specified

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

1, 2.5, and 5% w/w.

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no data
- Lymph node proliferation response: no data
- Other: In preliminary sighting tests, signs of systemic toxicity were noted at concentrations of 50%, 25%, and 10% w/w, but no signs of systemic toxicity were noted at a concentration of 5%.


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: no data
- Criteria used to consider a positive response: Test to control ratio greater than 3.0 indicates a "Positive" result.


TREATMENT PREPARATION AND ADMINISTRATION:
Animals were treated with 50 µL of the test substance (25 µL per ear) as a solution in dimethyl formamide.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

other: 2,4-dinitrobenzenesulfonic acid, sodium salt 1%, 10%, 20% v/v in 1% pluronic F-68 in distilled water

Statistics:

The Stimulation Index (SI) was calculated as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group.

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

0.7

Test group / Remarks:

4 animals in 1% w/w group

Results 2

Parameter:

SI

Value:

0.82

Test group / Remarks:

4 animals in 2.5% w/w group

Results 3

Parameter:

SI

Value:

0.69

Test group / Remarks:

4 animals in 5% w/w group

Cellular proliferation data / Observations:

No further details on results available.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered to be a non-sensitiser under the conditions of this study. Based on CLP regulation, the test item is considered not to be classified for skin sensitisation.