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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 toxicity, oral: Key study: The LD50 of laevo bornyl acetate in rats is greater than 5000 mg/kg bw. Supporting study: Based on the read-across approach, the oral LD50 was > 10000 mg/kg bw  in rats and 9000 mg/kg bw in mice.
Acute toxicity, dermal: Key study: The dermal LD50 in rabbit is greater than 10 mL/kg bw  (~10000 mg/kg bw). Supporting study: Based on the read-across approach, the dermal LD50 of laevo bornyl 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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 (rats) is greater than 5000 mg/kg/bw.
Executive summary:

The oral LD50 of laevo bornyl acetate in rats is greater than 5000 mg/kg/bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Key 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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: (~10000 mg/kg bw)
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 in rabbit is greater than 10 mL/kg bw (~10000 mg/kg bw).
Executive summary:

The dermal LD50 of laevo bornyl acetate in rabbits is greater than 10 mL/kg bw (~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:
Key study with Klimisch score = 2.

Additional information

Acute toxicity, oral:

Key study: The oral LD50 of laevo bornyl acetate in rats is greater than 5000 mg/kg/bw.

Supporting study: Based on the read-across approach from the analogue isobornyl acetate, the oral LD50 of laevo bornyl acetate in rats is greater than 10000 mg/kg/bw.

Supporting study: Based on the read-across approach from the analogue isobornyl acetate, the LD50 of laevo bornyl 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: The dermal LD50 in rabbit is greater than 10 mL/kg bw (~10000 mg/kg bw).

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


Justification for selection of acute toxicity – oral endpoint
One study available on the substance.

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
One study available on the substance

Justification for classification or non-classification

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