Heptanal, 2-(phenylmethylene)-, (2E)-

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: see 'Remark'

Remarks:

The investigations were completed prior to adoption of formal test guidelines but in principle the requirements of the test guidelines were initially derived from existing study designs and this series of investigations is considered to be consistent with the aims and objectives of the guidelines published subsequently.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Groups of rats, guinea pigs or mice were administered test material by oral intubation. Rats and guinea pigs were fasted prior to dosing. After administration the animals were observed for a period of two weeks and signs of toxicity or morbidity recorded together with any mortalities that occurred.
A median lethal dose was calculated using the method of Litchfield and Wilcoxon.
The purpose of the study was to determine oral toxicity of the materials in relation to food additive uses and so no effort to obtain chemically pure test materials was made but commercially available samples were used.

GLP compliance:

no

Remarks:

conducted prior to adoption of GLP principles

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Heptanal, 2-(phenylmethylene)-, (2E)-

EC Number:

800-696-3

Cas Number:

78605-96-6

Molecular formula:

C14 H18 O

IUPAC Name:

Heptanal, 2-(phenylmethylene)-, (2E)-

Details on test material:

The test material typically contains >94% of the trans (E) isomer and 4-5% of the cis (Z) isomer.

Test animals

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Details on test animals or test system and environmental conditions:

No study specific details provided. Groups of 10 young adult Osborne-Mendel rats were fasted for 18 hours prior to dosing (food was returned and available ad libitum from immediately after dosing). The rats were group housed and dosed by intubation.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No details provided for dose levels administered or how many groups were dosed in the study.

Doses:

No information

No. of animals per sex per dose:

Five

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: No information
- Other examinations performed: clinical signs, body weight gains and mortality

Statistics:

Litchfield and Wilcoxon method used to calculate median lethal dose and response slope with 95% confidence intervals

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 730 mg/kg bw

Based on:

test mat.

95% CL:

1.2

Remarks on result:

other: 95% CL values of 1.2-1.6 quoted for slope of the dose response curve, Slope = 1.4

Mortality:

No information provided for group mortality except time of death was between 4 hours and day 5 after dosing .

Clinical signs:

other: Depression and porphyrin-like deposit around the eyes

Gross pathology:

No information

Other findings:

No information

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose of amyl cinnamic aldehyde was calculated to be 3730 mg/kg bw which exceeds the limit dose level of 2000 mg/kg bw and so no classification is required for acute oral toxicity.

Executive summary:

Amyl cinnamic aldehyde was orally administered by intubation to groups of ten rats (five per sex) and mortality data analysed to calculate a median lethal oral dose. According to Litchfield and Wilcoxon method the LD50 was 3730 mg/kg bw. This result indicates amyl cinnamic aldehyde (2 -benzylideneheptanal) does not require classification for acute oral toxicity according to CLP.