Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
test performed prior to the GLP guidance
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
TEST MATERIAL
Name (stated on the report) : TETRAHYDRO CITRAL
Appearance: Colourless liquid

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 of 165 - 200 g supplied by Charles River UK

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Doses:
5.0, 2.0, 1.0 and 0.5 ml/Kg bodyweight
No. of animals per sex per dose:
1 dose per animal
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 female rat died after 48 hours after administration at the 5.0 ml/Kg bodyweight
Clinical signs:
no clinical sign

Any other information on results incl. tables

No deaths occured and no overt signs of toxicity were observed in the range finding study during the fourteen day observation period.

In the main study, one female rat died 48 hours after administration. The remaining animals survived the fourteen day observation period showing no overt signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of TETRAHYDRO CITRAL in rat is likely to be in excess of 5.0 ml/Kg bw. Hence the GHS criteria are not met for classification.
Executive summary:

For the range finding study, the animals were divided into groups of two (1 male and 1 female) per dose group.

In the main study the animals were divided into groups of ten (5 males and 5 females) per dose group.

The animals were fasted overnight prior to dosing. Immediately before dosing animals were individually weight , and the required dose administered as a single peroral injection using a metal cannula.

The animals were examined for overt sign of toxicity immediately after dosing, four hours after dosing and then daily for fourteen days.

No deaths occured and no overt signs of toxicity were observed in the range finding study during the fourteen day observation period.

In the main study, one female rat died 48 hours after administration. The remaining animals survived the fourteen day observation period showing no overt signs of toxicity.

The LD50 of TETRAHYDRO CITRAL in rat is likely to be in excess of 5.0 ml/Kg bw. Hence the GHS criteria are not met for classification.