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: 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
The animals were not weighted

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.