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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 conducted in accordance with GLP principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MEOE
- Analytical purity: 96% (analytical report No.: 06L00055)
- Test-substance No.: 04/0450-2

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: HanRcc:WIST(SPF)
- Source: RCC Ltd Laboratory Animal Services
- Age at study initiation: female animals approx. 8-12 weeks
- Fasting period before study: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Weight at study initiation: females 183 g (mean)
- Housing: Single in stainless steel wire mesh cages, type DK-III
- Diet (ad libitum): Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water (ad libitum): Tap water
- Acclimation period: at least 5 days for administration


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% CMC-solution (cleaned sodlum carboxymethylcellulose) in doubly distilled water
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study; Recording of signs and symptoms several times on the day of application, at least once each workday for the individual animals; A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays; Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
Clinical observation revealed impaired general state, dyspnoea and piloerection and were observed from hour 3 through to hour 5 after administration.
Body weight:
The mean body weights of the administration groups increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (3 females) examined at termination of the study.

Any other information on results incl. tables

Under the conditions of this study the median lethal dose of MEOE after oral administration was found to be greater than 5000 mg/kg body weight in rats.

Applicant's summary and conclusion