Registration Dossier

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: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,2`-Oxybisethanol, ethoxylated and propoxylated (>1< 4.5 mol EO and >1< 4.5 mol PO)
- Physical state: liquid, colorless, clear
- Analytical purity: >99%
- Test item number: 11/0042-1
- Lot/batch No.: T35/034/10
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: young adult animals (female animals approx. 10-11 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: 16 hours
- Housing: single housing in Makrolon cages (Type III)
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.85 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Administration 1: 3 females
Administration 2: 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 were recorded shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs was performed several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed:
A check for any dead or moribund animals was made at least once each workday.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality occurred.
Sex:
female
Dose descriptor:
other: LD50 (predicted)
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: According to OECD TG 423 (adopted 2001), Annex 2d
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.
Other findings:
No other findings were observed.

Applicant's summary and conclusion