Butanal, reaction products with aniline

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 acceptable and suficient documented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Six groups of 10 male Wister rats (average weight 160-180 g) received per gavage a single dose of 2000 to 6300 ml/kg bw Vulkacit 576. The animals were observed for mortality, weight and clinical signs through day 14.

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Butanal, reaction products with aniline

EC Number:

270-109-8

EC Name:

Butanal, reaction products with aniline

Cas Number:

68411-20-1

IUPAC Name:

aniline; butanal

Test material form:

not specified

Details on test material:

Vulkacit 576 = Butanal, reaction products with aniline

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000, 3100, 4000, 4500, 5000, 6300 µl/kg = 1990, 3084.5, 3980, 4477.5, 4975, 6268.5 mg/kg bw
According to EU Method A. 3, the relative density of the test item determined by use of an oscillating densitimeter (U-tube method) is 0.995 at 20° C (Bayer Technology Services, 2011).

No. of animals per sex per dose:

10 male animals/dose

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

3 830 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

The corresponding mortality for male rats was 0% (2000 µl/kg bw), 30% (3100 µl/kg bw), 40% (4000 µl/kg bw), 70% (4500 µl/kg bw), 90% (5000 µl/kg bw), 100% (6300 µl/kg bw), respectively.

A single dose of Vulkacit 596 caused on male rats the following signs of intoxication: sedation, diarrhoe, weight loss, reduction of general condition.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Six groups of 10 male Wister rats (average weight 160-180 g) received per gavage a single dose of 2000 to 6300 µl/kg bw Vulkacit 576. The animals were observed for mortality, weight and clinical signs through day 14.

The corresponding mortality for male rats was 0% (2000 µl/kg bw), 30% (3100 µl/kg bw), 40% (4000 µl/kg bw), 70% (4500 µl/kg bw), 90% (5000 µl/kg bw), 100% (6300 µl/kg bw), respectively.

A single dose of Vulkacit 596 caused on male rats the following signs of intoxication: sedation, diarrhoe, weight loss, reduction of general condition. The LD50 = 3830 mg/kg bw.