3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

other: LD50

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene

EC Number:

224-778-8

EC Name:

3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene

Cas Number:

4488-57-7

Molecular formula:

C10H14

IUPAC Name:

tricyclo[5.2.1.0²,⁶]dec-3-ene

Constituent 2

Reference substance name:

Dihydrodicyclopentadiene

IUPAC Name:

Dihydrodicyclopentadiene

Details on test material:

- Name of test material (as cited in study report): DHDCPD
- Physical state: Liquid
- Density: 1.04 g/ml
- Analytical purity: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Blue Spruce Farms, Inc. Altamont, New York, USA
- Age at study initiation:
- Weight at study initiation: 225-300g (males), 186-246g (females).
- Fasting period before study: 18 hours
- Housing: Individually in stainless steel or galvanised cages.
- Diet : Charles River RHM 3000 (ad libitum)
- Water : Tap water (ad libitum)
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: 11th January 1980 To: 30th January 1980

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DHDCPD administered as received.
Doses were calculated using pre-fasted body weights. All animals received the same concentration of the test material.

Doses:

0.43, 0.66, 1.02, 1.56 or 2.40 g/kg (430, 660, 1020, 1560 or 2400 mg/kg).

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 3 times per day on day of dosing and twice daily thereafter for 14 days.
- Frequency of weighing: Pre-fast, post-fast, day 7 and day 14.
Animals which did not survive were weighed at the time of death or at the time when they were found dead.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

The LD50 was calculated seperately for each sex by least squares regression analysis of arcsin transformation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

670 mg/kg bw

95% CL:

100 - 1 920

Mortality:

Mortality occured within 1-2 days after dosing and total mortality was: 4/10 at 430 and 660 mg/kg, 6/10 at 1020 mg/kg, 9/10 at 1560 and 2400 mg/kg.

Clinical signs:

other: Significant clinical signs (seen in animals at all doses) included decreased activity, ataxia, tonic convulsions, tremors, paralysed hind-quarters (1 female at 1560 mg/kg), staub tail (1 female at 2400 mg/kg), diarrhoea, urinary incontinence and/or saliva

Gross pathology:

Gross necropsy findings included: dark and/or mottled lungs; dark, blanched and/or mottled liver; pale, blanched kidneys; vascularisation of stomach and/or gastro-intestinal tract; granular, pale and/or dark spleen. Findings were seen in animals at all dose levels.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 and 95% confidence limits of dihydro dicyclopentadiene (DHDCPD) were calculated to be 670 (100 - 1920) mg/kg bw for males and females combined.

Executive summary:

Groups of 5 male and 5 female Sprague Dawley rats (fasted overnight) were dosed by gavage at levels of 430, 660, 1020, 1560 or 2400 mg/kg dihydro dicyclopentadiene (DHDCPD) and were observed daily for 14 days after dosing. Significant clinical signs (seen in animals at all doses) included decreased activity, ataxia, tonic convulsions, tremors, paralysed hind-quarters (1 female at 1560 mg/kg), staub tail (1 female at 2400 mg/kg), diarrhoea, urinary incontinence and/or salivation. All mortalities occurred one or two days after dosing. Gross necropsy findings, seen in animals at all dose levels, included dark and/or mottled lungs; dark, blanched and/or mottled liver; pale, blanched kidneys; vascularisation of stomach and/or gastro-intestinal tract; granular, pale and/or dark spleen. The LD₅₀ was calculated to be 670 (100 - 1920) mg/kg bw for males and females combined.