Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)

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:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)

EC Number:

605-659-3

Cas Number:

173046-61-2

Molecular formula:

Mixture of C6H11O3-[C3H6O]p-[C2H4O]q-[C3H3O]r-C7H14ON and C6H11O3-[C3H6O]p-[C2H4O]q-[C3H3O]s With: 0

IUPAC Name:

Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 92/355
- Physical state/Appearence: liquid, slight yellowish

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: Young adult animals
- Weight at study initiation: animals of comparable weight; (150-300 g (+/- 20%))
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available ad libitum
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum; KLIBA-Labordiaet 343, Klingenthalmuehle AG, Kaiseraugst, Switzerland
- Water (e.g. ad libitum): ad libitum; tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 -70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Remarks:

olive oil DAB 9 AT

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male animal died 5 days after application.

Clinical signs:

male animals: comprised impaired general state, dyspnoea, gasping, salivation, red crusted snout: these symptoms are considered to be unspecific; two mals animals appeared normal 1 day after application

Body weight:

The expected body weight gain has been observed in the course of the study.

Gross pathology:

Necropsy findings of the animal that died were general congestion, intensified bloody ulcers in the glandular stomach, partly bloody contents in the jejunum, severe flatulence in the gastrointestinal tract and intensified emaciation.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study the range of mortality after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.