Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 08, 2016 to June 23, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, propoxylated

EC Number:

500-041-9

EC Name:

Propylidynetrimethanol, propoxylated

Cas Number:

25723-16-4

Molecular formula:

C9 H20 O4

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Constituent 2

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono-2-propenoate

Cas Number:

1378240-17-5

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC9H16O4

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono-2-propenoate

Constituent 3

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), di-2-propenoate

Cas Number:

104956-81-2

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC12H18O5

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), di-2-propenoate

Constituent 4

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] mono-2-propenoate

Cas Number:

1378240-19-7

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC12H18O5 + C3H4O2

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] mono-2-propenoate

Constituent 5

Reference substance name:

Propylidynetrimethanol, propoxylated, esters with acrylic acid

EC Number:

500-123-4

EC Name:

Propylidynetrimethanol, propoxylated, esters with acrylic acid

Cas Number:

53879-54-2

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC15H20O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[(1-oxo-2-propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Constituent 6

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] di-2-propenoate

Cas Number:

1378240-20-0

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC15H20O6 + C3H4O2

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), mono[3-[(1-oxo-2-propen-1-yl)oxy]propanoate] di-2-propenoate

Constituent 7

Reference substance name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, ester ether with 3-hydroxypropanoic acid (6:2:1), [3-[(1-oxo-2-propen-1-yl)oxy]propanoate] tri-2-propenoate

Cas Number:

1378240-22-2

Molecular formula:

(C3H6O)n(C3H6O)n(C3H6O)nC12H18O5 + (C3H6O)n(C3H6O)n(C3H6O)nC15H20O6

IUPAC Name:

Poly[oxy(methyl-1,2-ethanediyl)], a-hydro-w-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, ester ether with 3-hydroxypropanoic acid (6:2:1), [3-[(1-oxo-2-propen-1-yl)oxy]propanoate] tri-2-propenoate

Constituent 8

Reference substance name:

Michaël adduct of propoxylated trimethylolpropane monoacrylate (TMP(PO)MA) with propoxylated trimethylolpropane triacrylate (TMP(PO)TA) and propoxylated trimethylolpropane monoacrylate (TMP(PO)MA)

Molecular formula:

Not available (UVCB substance)

IUPAC Name:

Michaël adduct of propoxylated trimethylolpropane monoacrylate (TMP(PO)MA) with propoxylated trimethylolpropane triacrylate (TMP(PO)TA) and propoxylated trimethylolpropane monoacrylate (TMP(PO)MA)

Constituent 9

Reference substance name:

Sum of other constituents

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Sum of other constituents

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Source: Velaz Prague, Czech Republic
Age at first dose: 8-12 weeks
Acclimation: 5 days prior to the start of treatment
Room temperature: 22 ± 2° C, relative humidity: 55 ± 10%
The light regimen was set to a 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany), water: tap water

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

The required amount of the test substance (according to the body weight and dose) was mixed with vehicle (olive oil) shortly before administration. The test substance was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test substance administered. After the test substance had been administered, food was withheld for further 3-4 hours.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All 6/6 females survived the limit dose of 2000 mg/kg

Clinical signs:

other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered

Gross pathology:

All animals were necropsied. During necropsy, no macroscopic changes were noticed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to rats.

Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423 (acute toxic class method), in compliance with GLP. The substance was administered by oral gavage to six female Wistar rats at 2000 mg/kg bw. Treated animals were observed for mortality, clinical signs and body weight changes for 14 d and were then subjected to gross pathological examination. No mortality was observed during the study. Animals lived through the observation period without signs of intoxication. Neither changes of health nor negative reactions were recorded. No body weight losses were observed in the first and second week after administration. In 2 animals, stagnation of body weight was observed. All animals were necropsied and no macroscopic changes in the organs were observed. Under the study conditions, the LD50 of the test substance was > 2000 mg/kg bw after single oral administration to rats (Hozova, 2016).