Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(2-aminomethylethyl)-.omega.-(2-aminomethylethoxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-02-05 - 1992-03-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Limited information on the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Physical state: liquid
- Storage condition of test material: Room temperature

Specific details on test material used for the study:

- Name as cited in study report: 6398-9-20
- Color: clear
- Storage: during storage no change in the physical state of test article
- Specific gravity: 0.948 g/mL

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Inc., Wilmington, Massachusetts, USA
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 155-291 g (dose-range finder), 157-232 g (main test); weight variation in each sex did not exceed +/- 20%
- Fasting period before study: yes
- Housing: individually in stainless steel wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 4.22 ml/kg bw (based on max. dose level 4000 mg/kg bw and specific gravity 948 mg/ml)

DOSAGE PREPARATION (if unusual): test article was dosed as received using specific gravity calculations.

Doses:

0 (water), 2000, 2500, 3000, 4000 mg/kg bw

No. of animals per sex per dose:

5 substance exposed animals, 3 control animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 1h, 4h, 24h after dosing and once daily thereafter; body weights at 0h, 7d and 14d after exposure (or when found dead).
- Necropsy of survivors performed: yes
- Other examinations performed: toxicological effects, viability, gross necropsy, histopathology (of control and highest dose group)

Statistics:

LD50 calculations according to Litchfield and Wilcoxon.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 885.3 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 400.7 - <= 3 467.7

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 922.1 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 308.9 - <= 3 698.2

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

2 627.2 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 157.7 - <= 3 198.8

Mortality:

No mortality in 6 control rats (3M/3F)
2000 mg/kg: 1/5 females
2500 mg/kg: 3/5 males and 2/5 females
3000 mg/kg: 1/5 males and 3/5 females
4000 mg/kg: 5/5 males and 5/5 females
All deads occurred on or 1 day after the day of exposure.

Clinical signs:

other: Decreased activity during the first few days after exposure only (only for substance exposed rats). Dyspnea during the first few days after exposure only (in 2500-3000-4000 dosed rats)

Gross pathology:

In exposed animals that died during the study: distended stomach and intestines (all dose levels), dark or pale organs (3000 and 4000 mg/kg).
No visible lesions in control animals and all survivors.

Other findings:

No treatment related findings compared to control rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

In view of the LD50 value of 2885 mg/kg bw in this rat study, the substance does not need to be classified for acute oral toxicity according to the CLP Regulation (EC)1272/2008.