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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December, 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study meets the EC Standards (conducted equivalent to OECD 401). Non GLP and only a very short description of method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
limited study design details in the report, limited details on test material and test animals and no environmental conditions: not expected to affect the outcome of the study
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene
EC Number:
247-851-6
EC Name:
[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene
Cas Number:
26619-69-2
Molecular formula:
C15H24O
IUPAC Name:
[1aR-(1aα,4aα,7α,8aS*)]-octahydro-4,4,8,8-tetramethyl-4a,7-methano-4aH-naphth[1,8a-b]oxirene
impurity 1
Chemical structure
Reference substance name:
7,7,8,8-tetramethyloctahydro-2,3b-methanocyclopenta[1,3]cyclopropa[1,2]benzen-4-ol
Cas Number:
29461-20-9
Molecular formula:
C15H24O
IUPAC Name:
7,7,8,8-tetramethyloctahydro-2,3b-methanocyclopenta[1,3]cyclopropa[1,2]benzen-4-ol
Test material form:
liquid
Details on test material:
- Name of test material (as cited in the expert statement): Folenox
- Chemical name: 4,4,8,8-Tetramethyloctahydro-4a,7-methanonaphtho[1,8a-b]oxirene (IUPAC)
- Empirical formula: C15H24O
- Structural formula: See IUCLID section 1

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 148 to 200 g
- Fasting period before study: 12 hours
- Housing: no data

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data.
Doses:
100, 316, 1000, 4000 and 6000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Observations for mortality and signs of effect were made for 7 days and survivors were sacrificed.
- Necropsy of survivors performed: no data

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: No toxic effects were observed.
Gross pathology:
No data.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study with male rats, performed equivalent to OECD 401 guideline, an LD50 >6000 mg/kg bw was determined.
Executive summary:

The test substance GIV 2-3907 - ISOLONGIFOLENE EPOXIDE was tested in an acute oral toxicity study with male rats, performed equivalent to OECD 401 guideline. No deaths occurred and no toxic effects were observed.

Based on the results, an LD50 >6000 mg/kg bodyweight was determined.

Note: Folenox is also named GIV 2 -3907 - Isolongifolene epoxide.