Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.',.alpha.'',.alpha.'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[.omega.-hydroxy-

Acute Toxicity: oral

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: Guideline study under GLP without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Poly(oxy-1,2-ethanediyl), a,a',a'',a'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[w-hydroxy-

EC Number:

608-035-9

Cas Number:

27014-42-2

IUPAC Name:

Poly(oxy-1,2-ethanediyl), a,a',a'',a'''-[1,2-ethanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[w-hydroxy-

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Body weight at start of study
male animals mean = 180 g (= 100 %)
s = ±7g
min = 172 g (- 4.4 %)
max = 189 9 (+ 5.0 %)
n = 5
female animals mean = 179 g (= 100 %)
s = ±7g
min = 171 g (- 4.5 %)
max = 188 9 (+ 5.0%)
n = 5

Age at the start of the study male animals approximately 7 weeks, female animals approximately 8 weeks

Randomization Randomization schemes 96.0196 and 96.0494

Animal maintenance in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals

Room temperature 22 ± 3°C

Relative humidity 50 ± 20 %

Lighting time 12 hours daily

Acclimatization at least one day (breeding at identical conditions)

Food ssniff"' R/M-H (V 1534), ad libitum

Withdrawal of food from about 16 hours before to 3 - 4 hours after treatment

Water tap water in plastic bottles, ad libitum

Animal identification fur marking with KMn04 and cage numbering

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Test groups
The acute oral toxicity of the substance was tested only at a dose level of 2000 mg/kg body weight.
The animals received the compound as a 20 % solution in deionized water, the application volume being 10 mt/kg body weight.
If no compound-related mortality is produced in this limit test according to the guidelines no full study has to be carried out.

Preparation of the test compound
The substance 1 was dissolved in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer.

Test procedure
The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: No symptoms were observed after application of 2000 mg/kg body weight.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically
visible changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance has a LD50>2000mg/kg bw

Executive summary:

The substance has a LD50>2000mg/kg bw