Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
review article or handbook
Title:
ECHA robust summaries for 198404-98-7
Author:
ECHA
Year:
2019
Bibliographic source:
ECHA robust summaries for 98404-98-7, ECHA,2019

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- 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
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

Test animals

Species:
rat
Strain:
other: HanIbm:WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
No data available

Administration / exposure

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

Results and discussion

Preliminary study:
No data available
Effect levels
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

Applicant's summary and conclusion

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.