Registration Dossier

Administrative data

Description of key information

Acute toxicity oral: LD50 for rats is greater than 10000 mg/kg bw.
Acute toxicity: dermal: LD50 is 20000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientific publication peer reviewed.
Principles of method if other than guideline:
LC50 oral (gavage) determined in mouse.
GLP compliance:
not specified
Test type:
acute toxic class method
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
9 000 mg/kg bw
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 = 9000 mg/kg bw (mice)
Executive summary:

The LD50 of isobornyl acetate in mice (gavage) is 9000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
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
Test type:
other: no data
Species:
rat
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.
Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 (rats) is greater than 10g/kg/bw.
Executive summary:

The oral LD50 of isobornyl acetate determined in rats is greater than 10g/kg/bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw
Quality of whole database:
Reliable

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:
no
Test type:
other: no data
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.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 in rabbit is greater than 20000 mg/kg bw
Executive summary:

The dermal LD50 of Isobornyl acetate for 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

Additional information

Acute toxicity, oral:

Weight of evidence: The oral LD50 determined in rats is greater than 10000 mg/kg/bw.

Weight of evidence: The LD50 in mice (gavage) is 9000 mg/kg bw.

Acute toxicity, dermal:

Key Study: The dermal LD50 of Isobornyl acetate for rabbits is greater than 20000 mg/kg bw.

Justification for classification or non-classification

Acute toxicity:

Oral: LD50>2000mg/kg bw: non classified

Dermal: LD50>2000mg/kg bw: non classified