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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, near guideline study, available as published report, adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
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): pseudocumene
- Physical state: Clear liquid
- Analytical purity: 98%+
- Specific gravity: 0.85
- no further details

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: approximately 9 weeks
- Weight on arrival: 200-261 g
- Fasting period before study: 16-20 hours prior to dosing
- Housing: 5 per cage in suspended wire mesh cages
- Diet: Purina rat chow ad libitum except for pre-dose fast
- Water: ad libitum
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: "temperature controlled", values not reported
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 12 September 1980 To: 21 October 1980

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
3510, 5000, 7120 or 10,140 mg/kg
No. of animals per sex per dose:
10 males (no females tested)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations made 3-4 hours after dosing and once daily for 14 days, for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: no
Statistics:
The LD50 was calculated according to the method of Litchfield JT Jr., and Wilcoxon F, JPET 96:99, 1949.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
6 000 mg/kg bw
95% CL:
4 920 - 7 320
Mortality:
Three rats died at 5.0 g/kg; seven rats died at 7.12 g/kg and all ten rats died following a dose of 10.14 g/kg. There were no deaths at 3.51 g/kg.
Clinical signs:
Lethargy and ptosis were seen at all four dose levels while ataxia and piloerection were only seen at the three highest levels. Other toxic signs, prostration, flaccid muscle tone, emaciation, tachypnea, diarrhoea, chromorhinorrhea and chromodacryorrhea were also noted at the highest levels at various times during the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of pseudocumene was 6000 mg/kg of body weight.
Executive summary:

Four groups of ten male rats were dosed orally with 98%+ Pseudocumene at levels of 3.51, 5.0, 7.12 and 10.14 g/kg of body weight. The LD50 calculated from these data was 6.0 g/kg. Lethargy and ptosis were seen at all four dose levels while ataxia and piloerection were only seen at the three highest levels. Other toxic signs, prostration, flaccid muscle tone, emaciation, tachypnea, diarrhoea,chromorhinorrhea and chromodacryorrhea were also noted at the highest levels at various times during the study.