Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of isoborneol is 6500 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is >7859 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is 7072 mg/kg bw in mice.

Acute oral toxicity: Supporting study: The acute oral LD50 value of isoborneol is 5200 mg/kg bw in rats.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of isoborneol was determined to be greater than 2000 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of isoborneol was determined to be greater than 15717 mg/kg bw in rabbits.

Acute dermal toxicity: Supporting study: The acute dermal LD50 value of isoborneol is higher than 5000 mg/kg bw in rabbits.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): 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 needs to be provided. The information is provided for dermal route.

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 review (peer reviewed). No data on GLP.
Principles of method if other than guideline:
No data on test method
GLP compliance:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: mean value of 5800-7200 mg/kg bw
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats
Executive summary:

According to the peer reviewed article, the acute oral LD50 value of the test substance is 6500 mg/kg bw in rats

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance L-Borneol which shares the same functional groups with the substance Isoborneol also has comparable values for the relevant molecular properties.
See attached the reporting format.
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6 500 mg/kg bw
Based on:
other: Read-across from an analogue
Remarks on result:
other: read-across from an analogue for which LC50 = 6500 mg/L
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of isoborneol is 6500 mg/kg bw in rats.
Executive summary:

Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of isoborneol is 6500 mg/kg bw in rats.

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:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance was >10000 mg/kg bw in rats.
Executive summary:

According to the peer reviewed article, the acute oral LD50 value of the test substance was >10000 mg/kg bw in rats.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which is the target substance.
See attached the reporting format.
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 7 859 mg/kg bw
Based on:
other: Read-across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 > 10000 mg/kg bw.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is >7859 mg/kg bw in rats.
Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol was determined to be >7859 mg/kg bw in rats.

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. No data on GLP.
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
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
9 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance in mice is 9000 mg/kg/bw.
Executive summary:

According to the peer reviewed publication, the acute oral LD50 value of the test substance is 9000 mg/kg bw in mice.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which is the target substance.
See attached the reporting format.
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
7 072 mg/kg bw
Based on:
other: Read-across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 = 9000 mg/kg bw
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is 7072 mg/kg bw in mice.
Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol was determined to be 7072 mg/kg bw in mice.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
No data on test method
GLP compliance:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
No. of animals per sex per dose:
10
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 200 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 300 - <= 6 200
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance is 5200 mg/kg bw in rats
Executive summary:

The acute oral LD50 value of the test substance is 5200 mg/kg bw in rats with a 95 % confidence interval of 4300 -6200 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
6 500 mg/kg bw
Quality of whole database:
Peer review article with Klimisch score = 2

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), 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 needs to be provided. The information is provided for dermal route.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
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 provided on the method.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute dermal LD50 value of the test substance was >20000 mg/kg bw in rabbits.
Executive summary:

According to the peer reviewed article, the acute dermal LD50 value of the test substance was >20000 mg/kg bw in rabbits.

Endpoint:
acute toxicity: dermal
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 test method
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.
Executive summary:

According to the peer reviewed article, the acute dermal LD50 value of the test substance was >2000 mg/kg bw in rabbits.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which is the target substance.
See attached the reporting format.
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 15 717 mg/kg bw
Based on:
other: Read-across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 > 20000 mg/kg bw.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of isoborneol is >15717 mg/kg bw in rabbits.
Executive summary:

Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of isoborneol was determined to be greater than 15717 mg/kg bw in rabbits.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue substance L-Borneol which shares the same functional groups with the substance isoborneol also has comparable values for the relevant molecular properties.
See attached the reporting format.
Reason / purpose:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: Read-across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 > 2000 mg/kg bw.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of isoborneol was determined to be greater than 2000 mg/kg bw in rabbits.
Executive summary:

Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of isoborneol was determined to be greater than 2000 mg/kg bw in rabbits.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
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
Type of coverage:
not specified
Vehicle:
not specified
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute dermal LD50 value of the test substance was >5000 mg/kg bw in rabbits.
Executive summary:

The acute dermal LD50 value of the test substance was >5000 mg/kg bw in rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Peer review article with Klimisch score = 2

Additional information

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of isoborneol is 6500 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is >7859 mg/kg bw in rats.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is 7072 mg/kg bw in mice.

Acute oral toxicity: Supporting study: The acute oral LD50 value of isoborneol is 5200 mg/kg bw in rats with a 95 % confidence interval of 4300 -6200 mg/kg bw.

Acute dermal toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute dermal LD50 value of isoborneol was determined to be greater than 2000 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of isoborneol was determined to be greater than 15717 mg/kg bw in rabbits.

Acute dermal toxicity: Supporting study: The acute dermal LD50 value of isoborneol is higher than 5000 mg/kg bw in rabbits.

Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route (Annex VII, 8.5.1.), 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 needs to be provided. The information is provided for dermal route.

Justification for classification or non-classification

Based on the available data (LD50 (oral) = 6500 mg/kg bw and LD50 (Dermal) > 2000 mg/kg bw), the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.