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Diss Factsheets

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:
guideline study without detailed documentation

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
434-600-2
EC Name:
-
Cas Number:
2628-16-2
Molecular formula:
CH3CO2C6H4CH=CH2
IUPAC Name:
4-ethenylphenyl acetate
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
maize oil

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 732 mg/kg bw
95% CL:
1 323 - 2 140
Remarks on result:
other:
Remarks:
Slope of the mortality curve: 67
Mortality:
Male: 700 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Male: 1429 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 2041 mg/kg bw; Number of animals: 5; Number of deaths: 4
Female: 700 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1429 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 2041 mg/kg bw; Number of animals: 5; Number of deaths: 2
Clinical signs:
Signs of toxicity related to dose levels:
Animals died at dosages of 1000 mg/kg or above. The deaths occurred on Days 1,2 or 3. Ante mortem signs comprised lethargy, decreased motor activity, staggering gait, muscle tremor, bradypnoea, tachypnoea, hyperpnoea, hypopnoea, piloerection, ungroomed appearance, closed eyes, cold to the touch, hunched posture and prone position.

Signs of reaction in surviving animals treated at 1000 mg/kg or above comprised lethargy, decreased motor activity, bradypnoea, tachypnoea, hyperpnoea, hypopnoea, râles, pigmented orbital secretion, staggering gait, piloerection, ungroomed appearance, cold to the touch, hunched posture, thin body conformation and prone position. Signs at 700 mg/kg were confined to salivation for 30 minutes after dosing in one male animal.

The surviving animals were overtly normal on Day 6, apart from two male and two female animals treated at 1429 mg/kg which showed thin body conformation or râles from Day 8 to Day 14 and a male treated at 2041 mg/kg which showed bradypnoea and hyperpnoea on Days 5 to 8.

The overall bodyweight gains of surviving animals treated at 1000 mg/kg or above were generally less than that expected for rats of this age and strain. The magnitude of the effect was broadly dosage-related in degree. One female treated at the highest dosage (2041 mg/kg) lost bodyweight (22 g) during the second week of the observation period.
Gross pathology:
Effects on organs:
Necropsy of the decedents revealed altered stomach contents and occasional observations of dark thymus, dark areas on the gastric mucosa and body surface staining.
Necropsy of the surviving animals was unremarkable.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria