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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study with acceptable restrictions. Non GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethyltriglycol methacrylat
- Substance type: organic
- Physical state: liquid
- Analytical purity: as supplied by Röhm GmbH: purity in the test report not mentioned, commercial grade assumed > 98,5% ; colourless liquid
- pH: 6.8

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF Wistar rats, sustrain TNO, Zucht Winkelmann, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: male. 211.6 - 239.8 g, female: 160.0 - 182.1 g
- Fasting period before study: 16 hours before administration, about 4 hours after application food was made available again
- Housing: Macrolon type III/ max 5 per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±2 °C
- Humidity (%): 50 - 85 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Range finding: 5, 2.5 and 1 mL/kg
Main study: 5 mL/kg
No. of animals per sex per dose:
5 m and 5 f per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of clinical observations: 15 min, 45 min, 1h, 2+3h, 6h,24/48h, 7d, 14d
- Frequency of measuring of the body weights: once at day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, other: avareness, reflexes, emotions, CNS-symptoms, coordination, autonomous functions, tone, respiration rate, body temperature
Statistics:
LD50 and it's confidence limits were calculated by the method of Finney DY: Probit Analysis, third ed., Cambridge, 1971.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Original value: LD50: > 5000 ml/kg, 14 days LD50; equals LD50: > 5100 mg/kg with a density of 1.02 g/cm³
Mortality:
No mortality observed.
Clinical signs:
The sample induced in the tested dosage obvious disturbed awareness with apathy, mainly obvious disturbance of coordination with abnormal body posture, slight reduced reflex excitability, slight piloerection and partly slight decreased respiration rate. The symptomes decribed above were observed first about 15 min. p.a. and last first in increased than in decreased intensity partly up to 6 h p.a.. Afterwards all animals showed a normal disposition.
Body weight:
Changes after the observation period (at day 14) showed a normal body weight gain.
Other findings:
No macroscopic findings in the cranial-, thoracic- and abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
According to the test result: LD50(14days) > 5100 mg/kg bw the test substance Ethyltriglycol methacrylate has to be classified as nontoxic in
respect of its acute oral toxicity.
Executive summary:

In an acute oral toxicity study according to OECD 401, a group of fasted male and female SPF Wistar rats were given a single oral dose of Ethyltriglycol methacrylate at a limit dose of 5000 ml/kg bw and observed for 14days.

 

Oral LD50Combined = > 5000 ml/kg bw equals ca. 5100  mg/kg  bw

OECD GHS Category 5 ranges from 2000 -5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).

    

Based on the results of this study ( LD50 limit test in male and female rats) Ethyltriglycol methacrylate is not classified according to EU-GHS and OECD GHS criteria.

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