Octanal, 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: Study conducted similarly to the future OECD Guideline No. 401. The test is non-GLP and the gross pathology is unknown, but most other criteria are met.

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)

Deviations:

yes

Remarks:

no data on gross pathology, on animals and environmental conditions

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): CFI-A (alpha-Hexyl Cinnamate Aldehyde)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 200-225 g
- Fasting period before study: 16 h
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Doses:

1780, 2670, 4000 and 6000 mg/kg bw

No. of animals per sex per dose:

10 male/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation was done after 1, 6 and 24 hours and daily thereafter for a period of 14 days
- Necropsy of survivors performed: no
- Other examinations performed: general symptomatology was observed

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 3 100 mg/kg bw

95% CL:

> 2 450 - < 3 750

Mortality:

1780 mg/kg bw; 1 out of 10 animals died
2670 mg/kg bw; 4 out of 10 animals died
4000 mg/kg bw; 7 out of 10 animals died
6000 mg/kg bw; 10 out of 10 animals died

Clinical signs:

other: Deaths in most cases occurred overnight or later and the animals appeared depressed or lethargic throughout the study. Anorexia was seen at all levels and, although the animals were not weighed at termination of study, most appeared to have lost weight. I

Any other information on results incl. tables

Dose	Deaths/day	Total deaths
1780 mg/kg bw	1/1	1/10
2670 mg/kg bw	2/2; 2/3	4/10
4000 mg/kg bw	6/3; 1/4	7/10
6000 mg/kg bw	6/1; 3/2; 1/3	10/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for Hexyl Cinnamic Aldehyde was found to be 3100 mg/kg bw

Executive summary:

In an acute oral toxicity study, groups of fasted Albinos rats (10 males/dose) were given a single oral dose of Hexyl cinnamic aldehyde (HCA) at doses of 1780, 2670, 4000 and 6000 mg/kg bw and observed for 14 days

 

Oral LD₅₀ Males = 3100 mg/kg bw (2450-3750)

 

Deaths in most cases occurred overnight or later and the animals appeared depressed or lethargic throughout the study. Anorexia was seen at all levels and, although the animals were not weighed at termination of study, most appeared to have lost weight. In several cases towards the end of the study, inner ear syndrome appeared but this was not thought to be a drug effect since it is not uncommon in rats. Animals dying the day of dosing went into severe depression and looked anoxic. No stimulation was seen.

 

Under the test conditions, HCA is not classified according to the Directive 67/548/EEC and the Regulation (EC) No. 1272/2008.

This study is considered as acceptable and satisfies the guideline requirement for an acute oral toxicity study.