Registration Dossier

Administrative data

Description of key information

Acute toxicity, oral: Weight of evidence: Based on the read-across approach, the oral LD50 of dextro alpha fenchyl acetate was >10000 mg/kg bw/day in rats and 9000 mg/kg bw/day in mice.
Acute toxicity, dermal: Key study: Based on the read-across approach, the dermal LD50 of dextro alpha fenchyl acetate was > 20000 mg/kg bw/day 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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. A scientific review (peer reviewed). No data on GLP.
Principles of method if other than guideline:
No data on the method.
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Read-across from an analogue

The data matrix is included in the reporting format attached.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the read-across approach from experimental data on the analogue isobornyl acetate, the oral LD50 (rats) is greater than 10000 mg/kg/bw.
Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the oral LD50 of dextro alpha fenchyl acetate in rats is greater than 10000 mg/kg/bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
Two studies are available, both 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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The analogue isobornyl acetate which shares the same functional groups with dextro alpha fenchyl acetate also has comparable values for the relevant molecular properties. A scientific review (peer reviewed). No data on GLP.
Principles of method if other than guideline:
No data provided on the method.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Sex:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
20 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Read-across from an analogue

The data matrix is included in the reporting format attached.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the read-across approach from experimental data on the analogue isobornyl acetate, the dermal LD50 in rabbit is greater than 20000 mg/kg bw
Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the dermal LD50 of dextro alpha fenchyl acetate in rabbits is greater than 20000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
20 000 mg/kg bw
Quality of whole database:
Study with Klimisch score = 2.

Additional information

Acute toxicity, oral:

Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the oral LD50 of dextro alpha fenchyl acetate in rats is greater than 10000 mg/kg/bw.

Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the LD50 of dextro alpha fenchyl acetate in mice (gavage) is 9000 mg/kg bw.

Acute toxicity, inhalation:

Data waiving (other justification): According to REACH Annex VIII, column 2, in addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.

Acute toxicity, dermal:

Key study: Based on the read-across approach from the analogue isobornyl acetate, the dermal LD50 of dextro alpha fenchyl acetate in rabbits is greater than 20000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
The study performed in rats has been selected.

Justification for selection of acute toxicity – inhalation endpoint
According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Based on available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no 1272/2008.