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)

Endpoint summary

Description of key information

LD50 (oral): > 2000 mg/kg bw;

LD50 (dermal): > 2000 mg/kg bw (read-across from structural analogues CAS 118800-30-9, CAS 195008-76-5 and CAS 173011-06-8)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The target substance Propylidynetrimethanol, ethoxylated and propoxylated, esters with acrylic acid, reaction products with diethylamine is an UVCB containing polymers differing in their chain lengths and various isomers of these polymers. Therefore, a number of structural similar polymers with different chain lengths and an UVCB containing also polymers of different molecular sizes, were used as source chemicals in this read-across approach.

The biotransformation is expected to be similar for target and source substances as all contain acryloyl groups undergoing acrylic acid metabolism, and tertiary amines .

Neither target nor source substances are harmful after single oral application.
Besides local effects caused by the irritating property of the substances, there were no indications of systemic adverse effects after repeated oral application of the target and sources substances.
The source substances showed no toxicity after single dermal application. For the target substance no data on acute dermal toxicity are available. However, on the basis of the high comparability of the target substance with the source substances discussed in the previous chapters, data from the source substances can be transferred to the target substance. Therefore, for the endpoint acute dermal toxicity a LD50 of greater 2000 mg/kg bw is assumed for the target substance as well, requiring no classification according to Regulation (EC) No. 1272/2008.

In conclusion, the proposed read-across approach is applied as an appropriate adaptation to the standard information requirements of Annex VIII of the REACH Regulation, in accordance with the provisions of Annex XI, 1.5.

Further details are decribed in the attached read-across justification.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no study available

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Oral toxicity:

This study was performed to assess the range of mortality following oral administration of the test material, applied as a solution in olive oil DAB 9, to Wistar rats. The Study procedure was based on the EEC guideline and modified according to the Acute Toxic Class Method. A Group of six fasted animals (3 males and 3 females) was given a single oral dose of the test material preparation in olive oil DAB 9 at a dose level of 2000 mg/kg body weight. Signs of toxicity have not been noted in the females. Signs of reaction to treatment in the male animals comprised impaired general state, dyspnoea, gasping, salivation and red crusted snout. These symptoms are considered to be unspecific. Two male animals appeared normal 1 day after application. The expected body weight gain has been observed in the course of the study. One mal animal died 5 days after application. 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. Under the conditions of this study the range of mortality after oral administration was found to be greater than 2000 mg/kg body weight for the male and female animals.

Dermal toxicity:

There are no data available to fulfil the acute toxicity data requirements set out in Annex VIII of Regulation (EC) No. 1907/2006. Therefore, the results from the acute dermal dose toxicity studies with structural analogue substances (CAS 118800-30-9, CAS 195008-76-5 and CAS 173011-06-8) are used to derive these information in a read-across approach. These studies were conducted according to OECD TG 404 under GLP conditions. Young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test substance to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

No mortality occurred and besides local irritating effects on the skin sites where the test substance was applied to, no signs of toxicity were observed.

The LD50 was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

No need for classification according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.