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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Richtlinie 84/449/EWG, test protocol corresponds to OECD 401, Limit Test
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate
EC Number:
613-645-3
Cas Number:
646505-36-4
Molecular formula:
see structural formula
IUPAC Name:
Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann, Borchen, Germany
- Acclimation period: at least 5 days
- Age at study initiation: males appr. 7-8 weeks, females appr. 9-10 weeks
- Fasting period before treatment: 16 hours
- Fasting period after treatment: 4 hours
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Volume of application: 10 ml/kg bw

The test substance was
Doses:
2000 mg/kg bw
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: twice daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
limit test, no statistics required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: clinical signs: temporarily increased salivation and breathing sounds which disappeared up to day 3 after treatment
Mortality:
none; one male died immediately after dosing as a consequence of misapplication of the test substance
Clinical signs:
other: temporarily increased salivation and breathing sounds which disappeared up to day 3 after treatment
Gross pathology:
no unusual lesions were noted; yellowish liquid was observed in the male which was died by misapplication

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test item was evaluated in a GLP-compliant study on male and female Wistar rats. The acute oral LD50 was determined with > 2000 mg/kg bw. As clinical signs temporarily increased salivation and breathing sounds were observed which disappeared up to day 3 after treatment.