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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
2020

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
An acute oral toxicity test carried out in groups of 2 young adults rats (range-finding study, one male and one female) at dose levels of 5.0, 2.0, 1.0 and 0.5ml/Kg bw;
A further group of 10 rats (main study, 5 male and 5 female) was treated at the highest dose level causing no deaths in the range-finding study.

The dose levels required for the range finding study were 5.0, 2.0, 1.0, and 0.5 ml/kg bw.

The animals were fasted overnigth prior to dosing. Immediately before dosing, the animals were individually weighted and the required dose administered as a single peroral injection using a metal cannyla. The animals were examined for the oover signs of toxicity immediately after dosing, 4 hours after dosing and then daily for 14 days.
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cyclamen aldehyde (p-isopropyl-α-methylhydrocinnamaldehyde)
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Specific details on test material used for the study:
Information not available.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Young adult Sprague-Dawley derived rats in the weight range 160 to 295g supplied ny Charles River U.K limeted, Margate, Kent.

The animals were housed in single sex group in cages (4 per cage range-finding study and 5 per cage main study). The cages were placed in a thermostatically controlled room under controlled lighting conditions.

Oxoid maintenance diet supplied by Herbert C. Styles and water were available ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
Sample preparation: for all dose levels the sample was dilluted with vegetebla oil to contain the required dos per kilogram in 10mL.
Doses:
The dose level required for the range-finding study were 5.0, 2.0, 1.0, and 0.5 mL/Kg bw.

The dose level required for the main study was the higest dose level causing no deaths in the range-finding study.
No. of animals per sex per dose:
range-finding:1 male/ 1 female per dose group.
main study: 5 males/ 5 females treated with 2.0 mL/kg/d.
Control animals:
not specified
Details on study design:
Animals were examined for over signs of toxicity immediately after dosing, 4 hours after dosing and then daily for 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.
Mortality:
In the dose range-finding study both rats dosed at 5.0mL/kg bodyweight died within 24 hours of administration. The remaining animals survived the 14 day observation period.
In the main study (doses at 2.0 mL/kg bw) all the animals survived the 14 day observation period showing no overt signs of toxicity.
Clinical signs:
No signs of toxicity at 2.0 mL/kg/d.
Body weight:
Not measured.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The results suggest that LD50 of Cyclamen Aldehyde is likely to be in excess of 2.0 mL/Kg bw.
Executive summary:

An acute oral toxicity test carried out in groups of 2 young adults rats (range-finding study, one male and one female) at dose levels of 5.0, 2.0, 1.0 and 0.5 ml/Kg bw.

A further group of 10 rats (main study, 5 male and 5 female) was treated at the highest dose level (2.0 ml/Kg/d) causing no deaths in the range-finding study.

In the range-finding study both rats dosed at 5.0 mL/Kg bw died withing 24 hours of administration. The remaining animals survived the 14 day observation period. In the main study (dosed at 2.0 mL/kg bw) all the animals survived the 14 day observation period showing no overt signs of toxicity.

The results suggest that the LD50 of Cyclamen Aldehyde is likely to be in excess of 2.0 mL/Kg bw.