Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-05-31 to 2007-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

cited as Directive 2004/73/EC B.1.tris

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Different oligomers of 1,1,1-tris-(omega-(2,2-dimethyl-3-lauroyloxypropylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Molecular formula:

C57H107N3O6 × [C3H6O](x+y+z); (x+y+z) = ca. 5.3 (average)

IUPAC Name:

Different oligomers of 1,1,1-tris-(omega-(2,2-dimethyl-3-lauroyloxypropylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Constituent 2

Reference substance name:

Different oligomers of 1,1-Bis(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino))-poly(oxy(methyl-1,2-ethanediyl))methyl)-1-(omega-hydroxy-poly(oxy(methyl-1,2-ethandiyl))-methyl)propane

Molecular formula:

C40H76N2O5 × [C3H6O](x+y+z); (x+y+z) = ca. 5.3 (average)

IUPAC Name:

Different oligomers of 1,1-Bis(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino))-poly(oxy(methyl-1,2-ethanediyl))methyl)-1-(omega-hydroxy-poly(oxy(methyl-1,2-ethandiyl))-methyl)propane

Constituent 3

Reference substance name:

Different oligomers of 1-(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-1-bis-(omega-hydroxy-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Molecular formula:

C23H45N1O4 × [C3H6O](x+y+z); (x+y+z) = ca. 5.3 (average)

IUPAC Name:

Different oligomers of 1-(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amino)-poly(oxy(methyl-1,2-ethanediyl))-methyl)-1-bis-(omega-hydroxy-poly(oxy(methyl-1,2-ethanediyl))-methyl)-propane

Constituent 4

Reference substance name:

"unknown" (oligomers)

Molecular formula:

no data

IUPAC Name:

"unknown" (oligomers)

Constituent 5

Reference substance name:

-

EC Number:

468-880-2

EC Name:

-

Cas Number:

102985-93-3

Molecular formula:

C17H32O3

IUPAC Name:

2,2-dimethyl-3-oxopropyl dodecanoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. Toxi Coop Ltd. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: 175 - 186 g
- Fasting period before study: yes
- Housing: Group caging (3 animals/cage); Type II. polypropylene/polycarbonate
- Diet: ad libitum; ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance"
- Water: ad libitum; tab water
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C
- Humidity (%): 41 - 68 %
- Air changes (per hr): 8 - 12 air exchanges/hour by central air-condition system.
- Photoperiod (hrs dark / hrs light): Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sunflower oil

Details on oral exposure:

VEHICLE Sunflower oil
- Concentration in vehicle: Concentration of 200 mg/mL was used
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: well-known, accepted vehicle
- Lot/batch no.: 2006.06.16

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical examinations, body weight assessment and gross necropsy were conducted. Animals were observed individually after dosing, once during the first half an hour, then 30 minutes, 1 h, 2 h, 3 h, 4 h, 6 h after the treatment and once each day.
The body weights were measured and recorded on day 0, on days 7 and 14 with a precision of 1 g.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

The test item caused no mortality at a dose level of 2000 mg/kg bw in female CRL:(WI) BR Wistar rats.

Clinical signs:

other: All animals were symptom-free on the day of treatment and during the 14-day observation period.

Gross pathology:

In one case pinprick-sized haemorrhages were found in the lungs due to the exsanguinations procedures. Hydrometra was observed in one animal, which is a common alteration, occurring sporadically in the experimental rats due to the sexual cycle.

Other findings:

No macroscopic alterations related to the toxic effect of the test item were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A single oral administration of the test item caused no toxic effects at 2000 mg/kg bw.

Executive summary:

A study was conducted according to OECD TG 423 and according to Directive 2004/73/EC method B.1.tris acute oral toxicity - acute toxic class method. The single-dose oral toxicity of the test item was evaluated in Wistar rats. Two groups of 3 female animals were received a single oral administration of the test item. The dose level was 2000 mg/kg bw. A gross necropsy examination was performed on all study animals at the time of death or scheduled euthanasia (day 14). No mortality occured and all animals were symptom-free on the day of treatment and during the 14-day observation period. The body weight development of each animal treated with the test item was normal during the two weeks observation period, similar to untreated female animals of the same age and strain. No macroscopic alterations related to the toxic effect of the test item were found. Under the conditions of the present study, a single oral administration of the test item Sika Hardener LTJ caused no toxic effects at 2000 mg/kg bw. In the female rat, an oral discriminating dose of 2000 mg/kg bw was concluded.