Registration Dossier

Diss Factsheets

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:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 423
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-Oxydiethanol, propoxylated
EC Number:
500-031-4
EC Name:
2,2'-Oxydiethanol, propoxylated
Cas Number:
9051-51-8
Molecular formula:
C4 H10 O3 (C3 H6 O) n, where n average >1 and n<4.5
IUPAC Name:
2,2'-Oxydiethanol, propoxylated
Details on test material:
- Physical state: liquid
- Purity: 100%

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
animals approx. 10 weeks; animals of comparable weight (172 -182 g).
single housing with free access to drinking water and food throughout the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
two groups of 3 females
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
6/6 female rats showed impaired and poor general state, dyspnoea, gasping, staggering, abdominal position, piloerection and ataxia at hour 1 until hour 5 after administration
Body weight:
no body weight retardation
Gross pathology:
no macroscopic pathological findings

Applicant's summary and conclusion

Executive summary:

Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg bw in rats.