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 d-alpha fenchol 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 d-alpha fenchol 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 d-alpha fenchol is 7072 mg/kg bw in mice.

Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is 2050 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 the test item 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 the test item was determined to be greater than 15717 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue fenchol, The acute dermal LD50 value of the test item was >2000 mg/kg bw in guinea pigs.

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:
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
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
2050, 2560, 3200, 4000 and 5000 mg/kg bw.
No. of animals per sex per dose:
2 animals for doses of 2050, 2560 and 4000 mg/kg bw
3 animals for dose of 3200 mg/kg bw
5 animals for dose of 5000 mg/kg bw
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 050 mg/kg bw
Based on:
test mat.
Mortality:
All deaths occurred between days 1 and 3.
At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw.
Clinical signs:
Clinical signs included lethargy, ataxia, tearing, comatose and flaccid (no further details were reported).
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute oral LD50 value of the test substance was found to be 2050 mg/kg bw in rats.
Executive summary:

The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 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:
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:
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:
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 fenchol which shares the same functional groups with the substance d-alpha fenchol 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:
2 050 mg/kg bw
Based on:
other: Read across from an analogue
Remarks on result:
other: read-across from an analogue for which LD50 = 2050 mg/kg bw
Mortality:
All deaths occurred between days 1 and 3.
At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw.
Clinical signs:
Clinical signs included lethargy, ataxia, tearing, comatose and flaccid (no further details were reported).
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is expected to be 2050 mg/kg bw in rats.
Executive summary:

The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 value of d-alpha fenchol was calculated to be 2050 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 shares the same functional groups with the substance D-alpha fenchol and 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:
> 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 d-alpha fenchol 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 d-alpha fenchol was determined to be >7859 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 d-alpha fenchol 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 d-alpha fenchol 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 d-alpha fenchol 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 isobornyl acetate undergoes rapid hydrolysis to acetic acid and isoborneol which shares the same functional groups with the substance D-alpha fenchol and 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:
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 d-alpha fenchol 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 d-alpha fenchol was determined to be 7072 mg/kg bw in mice.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 050 mg/kg bw
Quality of whole database:
Weight of evidence from several peer reviewed articles and secondary literature.

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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
No data on test method
GLP compliance:
no
Limit test:
yes
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths ocurred.
Clinical signs:
Not specified
Body weight:
Not specified
Gross pathology:
Not specified
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 guinea pigs.
Executive summary:

The acute dermal toxicity of Fenchol was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw.

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 fenchol which shares the same functional groups with the substance d-alpha fenchol 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
Mortality:
No deaths ocurred.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
Based on the read-across approach from the analogue fenchol, the acute dermal LD50 value of the d-alpha fenchol is expected to be >2000 mg/kg bw in guinea pigs.
Executive summary:

The acute dermal toxicity of Fenchol was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw. Based on these results, the read across approach was applied and the acute dermal LD50 value of the d-alpha fenchol was calculated to be >2000 mg/kg bw in guinea pigs.

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 shares the same functional groups with the substance D-alpha fenchol and 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:
> 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 the test item 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 the test item 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 D-alpha fenchol 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 the test item 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 the test item was determined to be greater than 2000 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:
Weight of evidence from several peer reviewed articles and secondary literature.

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 d-alpha fenchol 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 d-alpha fenchol 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 d-alpha fenchol is 7072 mg/kg bw in mice.

Acute oral toxicity: Weight of evidence: The acute oral toxicity of the test item was evaluated in rats. The test substance was administered at dose levels of 2050, 2560, 3200, 4000, and 5000 mg/kg body weight. Mortality and clinical observations were analyzed for 14 days after exposure. All deaths occurred between days 1 and 3. At 2050 and 2560 mg/kg bw, 1/2 animals died; 3/3 animals died at 3200 mg/kg bw; 2/2 animals died at 4000 mg/kg bw and 5/5 animals died at 5000 mg/kg bw. Clinical signs included lethargy, ataxia, tearing, comatose and flaccid. The acute oral LD50 value of the test substance was determined to be 2050 mg/kg bw. Based on these results, the read-across approach was applied and the acute oral LD50 value of d-alpha fenchol was calculated to be 2050 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 the test item 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 the test item was determined to be greater than 15717 mg/kg bw in rabbits.

Acute dermal toxicity: Weight of evidence. The acute dermal toxicity of the test item was evaluated in 2 guinea pigs. Test substance was administered via dermal application at 2000 mg/kg/body weight. The animals were observed for 14 days. No deaths occurred. Thus, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw. Based on these results, the read across approach was applied and the acute dermal LD50 value of the d-alpha fenchol was calculated to be >2000 mg/kg bw in guinea pigs.

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