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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
22 September - 18 October 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Doses of DCPD 75%: 500, 794, 1260 & 2000 mg/kg/bw
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DCPD 75%
- Physical state: clear, yellow-coloured liquid
- Composition of test material, percentage of components: 71.1% endo dicyclopentadiene, 0.8% exo dicyclopentadiene, 1.4% m-bicyclozonadiene, 15.2% CPD-MCPD codimers, 0.3% tricyclopentadiene, 1.3% CPD-butadiene codimer, 0.3% CPD-piperylene codimer, 0.3% CPD-isoprene codimer, <0.1% benzene , remainder misc. hydrocarbons.
- Specific gravity: 0.971
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Ltd., Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 120-146 g; females 120-150 g
- Fasting period before study: overnight
- Housing: In groups of up to 5, sexes separately in solid floor polypropylene cages with sawdust bedding.
- Diet: Rat and Mouse Expanded Diet No. 1 (Special Diet Services Ltd., Witham, Essex, UK) ad libitum (except for overnight fast immediately prior to dosing and approximately 2 hours after dosing)
- Water: Mains drinking water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-68
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 22 September 1988 To: 18 October 1988

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Maximum dose volume applied: 2.06 mL/kg
Minimum dose volume applied: 0.51 mL/kg
Doses:
500, 794, 1260 and 2000 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 and weighing: Observed 1 and 4 hours after dosing and once daily thereafter. Body weights recorded on day of dosing (day 0), days 7, 14 or at death.
- Necropsy of survivors performed: yes
Statistics:
The acute oral LD50 and 95% confidence limits calculated using the probit method.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
590 mg/kg bw
95% CL:
393 - 886
Sex:
male
Dose descriptor:
LD50
Effect level:
512 mg/kg bw
95% CL:
227 - 1 155
Sex:
female
Dose descriptor:
LD50
Effect level:
676 mg/kg bw
95% CL:
444 - 1 030
Mortality:
All deaths occurred one or two days following dosing. There were 2, 4, 5 and 5 male deaths and 1, 2, 5 and 5 females deaths in the 500, 794, 1260 and 2000 mg/kg bw groups respectively.
Clinical signs:
Hunched posture, piloerection, lethargy and decreased respiratory rate were present in all animals during the day of dosing. Ptosis was occasionally noted in animals dosed with 794 and 1260 mg/kg during this period. All rats dosed with 2000 mg/kg had ptosis 1 and 4 hours after dosing with occasional signs of ataxia at the 4 hour observation. Vocalisation was noted in one rat dosed with 1260 mg/kg at the 4 hour observation. Red/brown staining around the snout was present in surviving animals treated with 500 and 794 mg/kg one day after dosing. All survivors appeared normal 2 days after dosing.
Body weight:
All surviving animals showed expected body weight gain.
Gross pathology:
Haemorrhagic lungs, dark liver and sloughing of the non-glandular gastric epithelium was seen in decedents. No abnormalities were seen in animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information harmful if swallowed Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 and 95% confidence limits of DCPD 75% were calculated to be 590 (393 - 886) mg/kg bw for males and females combined; 512 (227 - 1155) mg/kg bw for males and 676 (444 - 1030) mg/kg bw for females.
Executive summary:

Groups of 5 male and 5 female Sprague Dawley rats (fasted overnight) were dosed by gavage at levels of 500, 794, 1260 or 2000 mg/kg DCPD and were observed daily for 14 days after dosing. At the 4 hour observation period rats dosed with high levels of DCPD (1260 or 2000 mg/kg bw) had hunched posture, piloerection, lethargy and decreased respiratory rate, with ptosis and occasional signs of ataxia seen in those dosed at 2000 mg/kg bw . All rats dosed at 1260 or 2000 mg/kg bw died one or two days after dosing. Haemorrhagic lungs, dark liver and sloughing of the non-glandular gastric epithelium was seen in decedents. The LD50 was calculated to be 590 mg/kg bw (male/female), 512 mg/kg for males and 676 mg/kg/bw for females.