Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Depression and porphyrin-like deposit around the eyes
Body weight:
No information
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.