Registration Dossier

Administrative data

Description of key information

Acute oral toxicity :

The LD50 value was considered to be >2000 mg/kg bw,when 5 male and female rats (HanIbm:WIST (SPF)) were treated with (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) orally.  

Acute dermal toxicity:

The LD50 value was considered to be > 2000 mg/kg bw,when 5 male and female rats (HanIbm:WIST (SPF)) were treated with the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) by semiocclusive application.  

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:
guideline study without detailed documentation
Justification for type of information:
Experimental study made available by ECHA
Qualifier:
according to
Guideline:
other: Annex V (B1)
Principles of method if other than guideline:
Acute oral toxicity study of test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was performed in rats.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (IUPAC name): (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)
- Common name: Lokanol
- Molecular formula: C15H26O
- Molecular weight: 222.3694 g/mol
- InChl: 1S/C15H26O/c1-13(2)10(6-12-8-15(12,13)4)5-11-7-14(11,3)9-16/h10-12,16H,5-9H2,1-4H3
- Substance type: Organic
Species:
rat
Strain:
other: HanIbm:WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
No data available
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Total :10
male: 5
female :5
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No deaths occurred and no signs of toxicity were observed.
Body weight:
No data available
Gross pathology:
Effects on organs:
No treatment-related macroscopic findings were observed.
Other findings:
No data available
Interpretation of results:
other: not classified
Conclusions:
The LD50 value was considered to be >2000 mg/kg bw,when 5 male and female rats (HanIbm:WIST (SPF)) were treated with (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) orally.
Executive summary:

In Acute oral toxicity study, 5 male and 5 female rats were treated with (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) orally in the concentration of 2000 mg/kg bw . No mortality was observed. Non specific signs of toxicity were observed. No abnormal effect on organ was observed at necropsy.Therefore,LD50 value was considered to be >2000 mg/kg bw,when rat (HanIbm:WIST (SPF)) were treated with

(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) orally. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Data is Klimicsh 2 and from experimental study made available by ECHA

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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Experimental study made available by ECHA
Qualifier:
according to
Guideline:
other: Directive 92/69/CE, B.3
Principles of method if other than guideline:
Acute dermal toxicity syudy of test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) was performed on rats.
GLP compliance:
yes
Test type:
other: not specified
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (IUPAC name): (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)
- Common name: Lokanol
- Molecular formula: C15H26O
- Molecular weight: 222.3694 g/mol
- InChl: 1S/C15H26O/c1-13(2)10(6-12-8-15(12,13)4)5-11-7-14(11,3)9-16/h10-12,16H,5-9H2,1-4H3
- Substance type: Organic
Species:
rat
Strain:
other: HanIbm:WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
No data available
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No data available
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Total:10
male : 5
female: 5
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs were observed during the test.
Body weight:
No effects on body weights were noted.
Gross pathology:
No effect on the organs.
Other findings:
Signs of toxicity (local):
COLOR / IRRITATION:
No staining / irritation noted
Interpretation of results:
other: not classified
Conclusions:
The LD50 value was considered to be > 2000 mg/kg bw,when 5 male and female rats (HanIbm:WIST (SPF)) were treated with the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) by semiocclusive application.
Executive summary:

In Acute dermal toxicity study, 5 male and 5 female rats were treated with the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)  (198404-98-7) in the concentration of 2000 mg/kg bw by semiocclusive application. No mortality was observed. Signs of toxicity related to dose levels not observed in treated rats. No abnormal effect was observed at necropsy. No local signs of toxicity with coloration/irritation were noted.Therefore,LD50 value was considered to be >2000 mg/kg bw,when rats were treated with (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)  (198404-98-7) by semiocclusive application. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Data is Klimicsh 2 and from experimental study made available by ECHA

Additional information

Acute oral toxicity :

In Acute oral toxicity study, 5 male and 5 female rats were treated with (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) orally in the concentration of 2000 mg/kg bw . No mortality was observed. Non specific signs of toxicity were observed. No abnormal effect on organ was observed at necropsy.Therefore,LD50 value was considered to be >2000 mg/kg bw,when rat (HanIbm:WIST (SPF)) were treated with

(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) (198404-98-7) orally. 

Acute dermal toxicity:

In Acute dermal toxicity study, 5 male and 5 female rats were treated with the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)  (198404-98-7) in the concentration of 2000 mg/kg bw by semiocclusive application. No mortality was observed. Signs of toxicity related to dose levels not observed in treated rats. No abnormal effect was observed at necropsy. No local signs of toxicity with coloration/irritation were noted.Therefore,LD50 value was considered to be >2000 mg/kg bw,when rats were treated with (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS)  (198404-98-7) by semiocclusive application. 

Justification for classification or non-classification

Thus, comparing this value with the criteria, the test chemical (1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL( MIXTURE OF DIASTEREOISOMERS) ( 198404-98-7) cannot be classified for acute oral and dermal toxicity.