Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6/6/2013-6/12/2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at a GLP accredited laboratory

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
IUPAC Name:
Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
Constituent 2
Chemical structure
Reference substance name:
1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
EC Number:
695-757-2
Cas Number:
897381-19-0
Molecular formula:
UVCB
IUPAC Name:
1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
Test material form:
other: liquid
Details on test material:
Clear light yellow liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
170-217 grams body weight range rats.
Lighting: 12 h light/ 12 h dark
Room temp: 17-23
Relative Humiditiy: 22 to 84 %
Food: Animals were fasted overnight prior to dose administration. Food was returned to the animals 30 mins after dosing.
Water: Water was available ad libitum.
Acclimation: A min of 5 days prior to dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was adminsterednon D1 to each rat as a single dose via oral gavage. Animals were fasted overnight prior to dose adminstration. Each animal received its designated dose based on fasted bw. Dose volume was 2 mL/kg and was based on the relative density of 1.0 g/mL as per the MSDS.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 female rats with 170-217 grams body weight range.
Details on study design:
Initally one rat was dosed at 2000 mg/kg. No mortality was observed, and in accordance with the guideline the study continued with the dosing of another 4 females at 2000 mg/kg. Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 mins, 4 h post dose, and daily thereafter through D15. BW were recorded on the day of dosing, and on D8 and D15.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
For the dose of 2000 mg/kg, no mortality was observed in any of the animals.
Clinical signs:
other: Animal 3381 exhibited clinical signs of abnormal gait and stance piloerection, decreased activity, and decreased body tone at 30 minutes post dose.Clinical signs of prostration and labored respiration were observed in this animal at 4 hours post dose. Ani
Gross pathology:
Terminal necropsy revealed no visible lesions in the any of the animals receiving test article at 2000 mg/kg.

Any other information on results incl. tables

No biologically significant effect was seen on body weights on Days 8 or 15. No mortality was observed in the initial animal (3381) dosed during the limit study at 2000 mg/kg. Animal 3381 exhibited clinical signs of abnormal gait and stance piloerection, decreased activity, and decreased body tone at 30 minutes post dose. Clinical signs of prostration and labored respiration were observed in this animal at 4 hours post dose. Animal 3381 appeared normal from Days 2-15. Terminal necropsy of animal 3381 revealed no visible lesions.

No mortality was observed when the additional four animals (3382-3385) were added to the study at 2000 mg/kg. Animal 3382 exhibited clinical signs of prostration and labored breathing 30 minutes post dose and at 4 hours post dose exhibited abnormal gait and stance decreased body tones piloerection, decreased activity.

Animal 3383 exhibited clinical signs of abnormal gait and stance, decreased body tone, decreased activity and piloerection 30 minutes post dose and at 4 hours post dose.

Animals 3384 and 3385 exhibited clinical signs of abnormal gait and stance, decreased body tone and piloerection 30 minutes post dose and at 4 hours post dose. Animals 3382-3385 appeared normal from Days 2-15. Terminal necropsy of the animals revealed no visible lesions.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the oral LD50 for PD 206 in rats was estimated to be greater than 2000 mg/kg and hence PD 206 is not classified based upon the EU CLP and DSD.

Executive summary:

The purpose of this study was to assess the toxicity of the test article following a single oral dose to the rat. Initially one female Sprague Dawley rat was dosed at 2000 mg/kg. No mortality was observed at 2000 mg/kg and in accordance with the guideline the study continued with the dosing of another four females at 2000 mg/kg. Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 minutes. 4 hours post-dose, and daily thereafter through Day 15. Body weights were recorded on the day of dosing (Day 1), and on Days 8 and 15. All rats were euthanized by C02 asphyxiation and necropsied on Day 15.

For the dose of 2000 mg/kg, no mortality was observed in any of the animals. Based on the results of this study, the oral LD50 for PD 206 in rats was estimated to be greater than 2000 mg / kg.