Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: supporting study: The acute oral LD50 value of the test substance is greater than 5000 mg/kg bw in rats.

Acute dermal toxicity: supporting study: The acute dermal LD50 value of the test substance was greater than 5000 mg/kg bw in rabbits.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
A scientific review (peer reviewed). No data on GLP.
Principles of method if other than guideline:
-principle of test: Ten rats received single oral doses of 5.0 g/kg test material each. Animals were observed for 14 days. No details on the method.
Test type:
acute toxic class method
Species:
rat
Sex:
not specified
Route of administration:
oral: unspecified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
not specified
Details on study design:
Animals were observed for 14 days
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Two animals died (2/10).
Clinical signs:
No adverse clinical signs were observed
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Oral LD50 (rats) is greater than 5000 mg/kg bw.
Executive summary:

The acute oral LD50 of fenchyl acetate was reported to exceed 5000 mg/kg bw. Ten rats received single oral doses of 5.0 g/kg test material each. Animals were observed for 14 days. Two animals died (2/10). No adverse clinical signs were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
supporting study with Klimisch score = 2

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A scientific review (peer reviewed). No data on GLP. Evaluated during a skin absorption study.
Principles of method if other than guideline:
-Principle of test: Acute dermal toxicity was evaluated during a skin absorption study. Two mice were each administered a single 4-hour dermal application of neat fenchyl acetate on the shaved abdominal skin. Observations were made after 4 hours.
GLP compliance:
no
Test type:
other: no data
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No (0/10) deaths were observed.
Clinical signs:
No clinical signs were observed
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The dermal LD50 in rabbit is greater than 5000 mg/kg bw
Executive summary:

The acute dermal LD50 for fenchyl acetate in rabbits exceeded 5000 mg/kg based on no (0/10) deaths at that dose. Ten rabbits each received a single dermal application of neat test material. Animals were observed for 14 days. No clinical signs were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
supporting study with Klimisch score = 3

Additional information

Acute oral toxicity: supporting study: The acute oral LD50 of fenchyl acetate was reported to exceed 5000 mg/kg bw. Ten rats received single oral doses of 5.0 g/kg test material each. Animals were observed for 14 days. Two animals died (2/10). No adverse clinical signs were observed.

Acute dermal toxicity: supporting study: The acute dermal LD50 for fenchyl acetate in rabbits exceeded 5000 mg/kg based on no (0/10) deaths at that dose. Ten rabbits each received a single dermal application of neat test material. Animals were observed for 14 days. No clinical signs were observed.

Justification for classification or non-classification

The substance is classified as Aspiration Toxicity Category 1, H304 in accordance with CLP Regulation (EC) no. 1272/2008 since it is a hydrocarbon and has a kinematic viscosity less than 20,5 mm2/s at 40 ºC.