Reaction mass of undec-8-enal and undec-9-enal and undec-10-enal

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

non-GLP, pre-OECD

Justification for type of information:

The information is used for read across to Intreleven aldehyde.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The result derived from read across is sufficiently reliable because all Annex XI criteria are met.

Justification for type of information:

The read across justification is presented in the Endpoint summary and the accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

other: Not acute toxic

Remarks:

according to EU CLP criteria (1272/2008/EC and its updates)

Conclusions:

Based on the results of the study for read-across substance Undec-10-enal, an acute oral LD50 of >5000 mg/kg bw was determined for Intreleven aldehyde.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Undec-10-enal

EC Number:

203-973-1

EC Name:

Undec-10-enal

Cas Number:

112-45-8

Molecular formula:

C11H20O

IUPAC Name:

undec-10-enal

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 grams
- Fasting period before study: yes, overnight
- Housing: Individually
- Diet (e.g. ad libitum): commercial diet
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% (v/v)
- Justification for choice of vehicle: not specified

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: after one and four hours, and thereafter daily.
- Necropsy of survivors performed: yes.
- Other examinations performed: toxic signs and mortality were recorded.

Statistics:

The LD50 was calculated according to Horn's method (Horn, H.J., Biometrics, 12, 311-322, 1956).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Toxic signs found were diarrhea, depression and salivation.

Body weight:

No information.

Gross pathology:

Abnormalities were noted.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute toxic

Remarks:

according to EU CLP criteria (1272/2008/EC and its updates)

Conclusions:

Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Undec-10-enal.

Executive summary:

An acute oral toxicity study was performed according to a method similar to OECD TG 401, as the study was performed non-GLP and pre-OECD (it was rated Klimisch 2). In this study, 10 rats were orally administered Undec-10-enal at a dose level of 5000 mg/kg bw. The mortality rate of the rats was 0/10. Clinical signs observed were diarrhea, depression and salivation. Gross necropsy was performed at end of term, but no abnormalities were found. Under the conditions of this test, an acute oral LD50 of >5000 mg/kg bw was determined for Undec-10-enal.