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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-04-22 to 1992-07-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Limited information on the test substance available.

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 402 (Acute Dermal 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
- Lot/Batch number: 6398-9-20
- Color: clear
- Storage: during storage no change in physical state of the test article
- specific gravity: 0.948 g/ml

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA, USA
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2233 - 3574 g
- Fasting period before study: no, not applicable
- Housing: individually in 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): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: no data
- % coverage: at least 10% of the body surface was cleared
- Type of wrap if used: rubber dam and an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): control: 5.6-7.3 ml water; 500 mg/kg dose: 1.3-1.9 ml test substance; 2000 mg/kg dose: 5.4-7.5 ml; 3200 mg/kg dose: 9.7-11.4 ml; 4000 mg/kg dose: 9.4-12.2 ml.
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

0 (water), 500, 2000, 3200, 4000 mg/kg bw

No. of animals per sex per dose:

5 in substance-treated groups and 3 in controls.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations once daily; 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:

Method of Litchfield & Wilcoxon.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 979.7 mg/kg bw

Based on:

test mat.

95% CL:

>= 993.8 - <= 8 934.1

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 979.7 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 037.4 - <= 4 357.9

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

2 979.7 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 037.4 - <= 4 357.9

Mortality:

Control: no mortality
500 mg/kg: no mortality
2000 mg/kg: no mortality
3200 mg/kg: 4/5 females and 4/5 males died during the first 3 days
4000 mg/kg: all animals died within 2 days.

Clinical signs:

other: Decreased activity, abnormal gait, abnormal stance, dyspnea, body drop, prostration in 2000-3200-4000 mg/kg dose animals. No clinical signs in control animals and in 500 mg/kg dose animals. Necrosis of the skin at the application site was observed in all

Gross pathology:

Animals that died during the study: discolored thymus and liver, prominent lobular pattern throughout the liver.
Survivors: no relevant effects.

Other findings:

Histopathology: no treatment related effects.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

In view of the LD50 value of 2980 mg/kg bw in this rabbit study, the substance does not need to be classified for acute dermal toxicity according to the CLP Regulation (EC) 1272/2008.