Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 Apr - 13 May 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethane- 1,2-diol, propoxylated
EC Number:
500-078-0
EC Name:
Ethane- 1,2-diol, propoxylated
Cas Number:
31923-84-9
Molecular formula:
HO(C3H6O)nC2H4(C3H6)nOH sum of n: >1 - <4.5 mol PO
IUPAC Name:
Ethane-1,2-diol, propoxylated
Details on test material:
- Physical state: liquid
- Content: 100%
- molecular weight: approx. 235
- Stability under test conditions: analytically approved

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HsdCpb:Wu
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: demineralized water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
other: LD50 cut-off
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
piloerection, decreased motility, closed eyelids, hunched posture, narrowed palpebral fissure, poor reflexes, poor general condition, uncoordinated gait and abdominal and lateral position
Body weight:
no effects on weight gain
Gross pathology:
no findings
Other findings:
none

Any other information on results incl. tables

Dose (mg/kg bw) Toxicological results  Onset and duration of clinical signs  Onset of mortality
(1st) 2000 0 / 3/ 3 15´- 6h --- 
(2nd) 2000 0 / 3/ 3 15´- 6h --- 

Toxicological results:

number of dead animals / number of animals with clinical signs after treatment / number of animals treated

Additional detailed tables are attached below under 'Attached background material'.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
According to OECD guideline 423 the LD50 cut-off of 5000 mg/kg bw.