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Toxicological information

Acute Toxicity: oral

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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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
other: LD50
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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.
Body weight:
Animals gained weight during the observation period.
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.