Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Data on a single study reported in different reports or publications

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Unnamed
Year:
1992
Reference Type:
secondary source
Title:
Unnamed
Year:
1985
Report date:
1985
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Guideline:
other:
Principles of method if other than guideline:
Method not detailed. Five male and five female Fischer 344 rats, five female CS7BL/6 mice and five male Golden syrian hamsters were treated with undiluted test substance at a maximum dose level of 20 mL/kg body weight and observed for 14 days.
GLP compliance:
no
Remarks:
Pre-GLP but the experiments were conducted according to the "Guide for the Care and Use of Laboratory Animals," Institute of Laboratory Animal Resources, National Research Council.
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
EC Number:
220-585-8
EC Name:
(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene
Cas Number:
2825-82-3
Molecular formula:
C10H16
IUPAC Name:
(1R,2S,6R,7S)-tricyclo[5.2.1.0^{2,6}]decane
Test material form:
liquid

Test animals

Species:
other: rats, mice and hamsters
Strain:
other: rats: Fischer 344; mice: C57BL/6; hamsters: Golden Syrian
Sex:
male/female
Details on test animals or test system and environmental conditions:
Not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Doses:
20 mL/kg bw
No. of animals per sex per dose:
rats: 5/sex/dose; mice: 5 females/dose; hamsters: 5 males/dose
Control animals:
no
Details on study design:
Five male and five female Fischer 344 rats, five female CS7BL/6 mice, five male Golden syrian hamsters; maximum dose of 20 mL/kg body weight; observation for 14 days.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Rats
Remarks:
ca. LD50 > 18.8 g/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Hamsters
Remarks:
ca. LD50 > 18.8 g/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 3.9 mL/kg bw
Based on:
test mat.
95% CL:
>= 2.2 - <= 6.9
Remarks on result:
other: Mice
Remarks:
LD50 calculated using the moving average method of Weil. ca. LD50 = 2.8 g/kg bw
Mortality:
Partial mortality in rats and hamsters.
In mice, all deaths occurred within 48 hours of dosing.
Clinical signs:
Convulsions were observed immediately preceding death.
Gross pathology:
Necropsy of dead revealed congested lungs and GI tract.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Under the test conditions, the substance is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and classified in Category 5 according to the GHS as the worst-case estimated oral LD50 is between 2000 than 5000 mg/kg bw.
Executive summary:

In an acute oral toxicity study performed in 1979, five male and five female Fischer 344 rats, five female C57BL/6 mice and five male Golden syrian hamsters were treated with undiluted test material at a dose level of 20 mL/kg bw. Animals were then observed for 14 days.

Deaths observed in rats and hamsters but not enough to determine a LD50 value.

In mice, deaths occurred within 48 hours of dosing with convulsions were observed immediately preceding death.

Necropsy of dead revealed congested lungs and GI tract.

In rats and hamsters, oral LD50 > 20 mL/kg bw, which is equivalent to 18.8 g/kg bw.

In female mice, oral LD50 = 3.9 mL/kg bw, which is equivalent to 2.8 g/kg bw.

Under the test conditions, the substance is not classified according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and classified in Category 5 according to the GHS as the worst-case estimated oral LD50 is between 2000 and 5000 mg/kg bw.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.