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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: Guideline study performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Purity: >99.8%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, UK
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: males 160-180g, females 148-163g
- Fasting period before study: overnight before study
- Housing: Housed in solid-floor polypropylene cages with sawdust bedding in groups of 5.
- Diet: Rat and Mouse expanded Diet No.1 ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 42 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All test animals were dosed once by gavage (metal cannula attached to a graduated syringe). The amount administered to each test animal was calculated according to its bodyweight at the time of dosing.
Doses:
Range-finding study: 5000 mg/kg
Definitive study: 5000 mg/kg
No. of animals per sex per dose:
Range-finding study: 1 male; 1 female
Definitive study: 5 male; 5 female
Control animals:
no
Details on study design:
Range-finding study: a range-finding study was conducted to determine a dosing regime for the definitive study. Animals were observed for signs of toxicity and mortality at 0.5, 1, 2 and 4 hours after dosing and then once daily for 5 days.

Definitive study: After dosing, animals are observed for signs of toxicity or mortality at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Body weights are recorded on day 0 (before dosing) and on days 7 and 14. At the end of the study, all test animals are killed and subjected to a gross pathological examination - this consists of an external examination and opening of the abdominal and thoracic cavities. Any macroscopic abnormalities were noted. No tissues were retained.

Results and discussion

Preliminary study:
No deaths were observed. Signs of toxicity observed include ataxia and/or hunched posture. Based on the result of this range-finding study a dose of 5000 mg/kg was selected for the definitive study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths observed.
Clinical signs:
Ataxia, hunched posture, lethargy, decreased respiratory rate and laboured respiration. All animals recovered 1 day after dosing.
Body weight:
All test animals showed gains in bodyweight within the expected range.
Gross pathology:
No abnormalities observed.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the acute oral toxicity of ethyl methyl carbonate to rats was evaluated and gave an LD50 of >5000 mg/kg.