Butanal, reaction products with aniline

Endpoint summary

Description of key information

A valid oral toxicity study and a sufficient documented acute dermal toxicity study from a reliable source are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

Species:

rat

Strain:

Wistar

Sex:

male

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

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

3 830 mg/kg bw

Based on:

test mat.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 830 mg/kg bw

Quality of whole database:

The materials/methods and results are described in detail und are sufficient for evaluation.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and sufficient documented

Principles of method if other than guideline:

Two male and 2 one female rabbit were applied the undiluted test substance for 24 hours. The animals were examined for mortality, clinical signs and a gross pathology was performed on survivors on day 14.

GLP compliance:

not specified

Test type:

standard acute method

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

5010 or 7940 mg/kg bw.

No. of animals per sex per dose:

5010 mg/kg bw: 1 animal (male)
7940 mg/kg bw: 2 animals (male and female)

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

7 940 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died.

Signs of intoxication: reduced appetite and activity four to seven days. The survivors showed areas of slight liver dicoloration.

Interpretation of results:

GHS criteria not met

Executive summary:

Two male and 2 one female rabbit were applied the undiluted test substance in doses of 5010 or 7940 mg/kg bw for 24 hours. The animals were exmained for mortality, clinical signs and a gross pathology was performed on surviviers on day 14. None of the animals died.

Therefore the LD50 is > 7940 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

7 940 mg/kg bw

Quality of whole database:

The materials/methods and results are described sufficient for evaluation

Additional information

In the acute oral toxicity study 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, diarrhea, weight loss, reduction of general condition. The LD50 = 3830 mg/kg bw.

In the acute dermal toxicity study 2 male and 2 one female rabbit were applied the undiluted test substance for 24 hours. The animals were examined for mortality, clinical signs and a gross pathology was performed on survivors on day 14. None of the animals died.

Therefore the LD50 is > 7940 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Key study is used

Justification for selection of acute toxicity – dermal endpoint
key study is used

Justification for classification or non-classification

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.