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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
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
- Test-substance No.: 04/0450-2
- Analytical purity: 96% (analytical report No.: 06L00055)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/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: male animals approx. 8-10 weeks, female animals approx. 12-14 weeks
- Weight at study initiation: males 247 g, females 229 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

Type of coverage:
semiocclusive
Vehicle:
other: 0.5% CMC-solution (cleaned sodlum carboxymethylcellulose) in doubly distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm2
- Type of wrap if used: The bandage consisted of four Iayers absorbent gauze, and Fixomull stretch (adhesive fleece)


REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water.
- Time after start of exposure: 24 h

Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
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:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No systemnic clinical observations were observed during clinical examination. No local effects were observed.
Body weight:
The mean body weights of the animals increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined at termination of the study.

Any other information on results incl. tables

Under the conditions of this study the acute dermal median lethal dose (LD50) of MEOE after dermal application was found to be greater than 2000 mg/kg body weight in male and female rats.

Applicant's summary and conclusion