Benzenamine, N-phenyl-, styrenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed similar to OECD 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Remarks:

study performed prior to GLP implementation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzenamine, N-phenyl-, styrenated

EC Number:

270-485-3

EC Name:

Benzenamine, N-phenyl-, styrenated

Cas Number:

68442-68-2

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

4-(1-phenylethyl)-N-[4-(1-phenylethyl)phenyl]aniline

Test material form:

liquid: viscous

Details on test material:

- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: Wistar-II, SPF

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder Winkelmann
- Weight at study initiation: 160-180g
- Housing: 5 animals / cage

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Lutrol

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2ml/kg

Doses:

5 g/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 1, 2, 3, 4, 5, 6, 7, 14
- Other examinations performed: clinical signs, bodyweight

Statistics:

Calculation of LD50 according to Fink and Hund, Arzneim.-Forsch. 15, 1965, 624

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities observed

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities observed

Mortality:

none

Clinical signs:

other: no symptoms observed on any observation day

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was conducted with a scientifically reasonable study design similar to OECD 401 on the registered substance itself with acceptable deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the toxicity of the test item towards rats. No rats died or showed symptoms at a dose of 5 g/kg bw, so the substance can be considered as relatively harmless and no classification as acute toxic according to Regulation 1272/2008 is triggered.

Executive summary:

In an acute oral toxicity study similar to OECD 401, groups of young male Wistar-II-rats (10/dose) were given a single oral dose of the test item in Lutrol at a limit dose of 5000 mg/kg bw and observed for 14 days.

 

Oral LD₅₀Males > 5000 mg/kg bw

Oral LD₀Males ≥ 5000 mg/kg bw

 

No mortalities occurred and no symptoms were observed at this dose. The test item is of low Toxicity based on the LD₅₀ in males. No classification as acute toxic according to Regulation 1272/2008 is triggered.