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)

Endpoint summary

Description of key information

In a acute oral toxicity with the test item according to OECD guideline 438 an an oral discriminating dose of 2000 mg/kgbw of Sika Hardener LTJ was estimated.

 

One additional read across study is available with the hydrolysis product of the test item Aldehyd L. The LD 50 was determined to be >2000 mg/kg bw.

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

Study period:

2007-05-31 to 2007-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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

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.

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

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and Guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

 For the target substance (SIKA Hardener LTJ, CAS 613246-79-0) data on acute oral toxicity is available. Because the substance itself decomposes rapidly during use a further read across study with the hydrolysis product Aldehyd L (products 2,2-Dimethyl-3-lauroyloxypropanal, CAS No. 102985-93-3) was filled in.

 

LTJ is a reaction mixture (different oligomeres) of the two substances 2,2-Dimethyl-3-lauroyloxypropanal (CAS No. 102985-93-3) and Polyetheramin T 403 (CAS No. 39423-51-3). During use of the substance as hardener it hydrolysis into the mentioned degradation products 2,2-Dimethyl-3-lauroyloxypropanal (CAS No. 102985-93-3) and Polyetheramin T 403 (CAS No. 39423-51-3).

 

Oral

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 (VP) caused no toxic effects at 2000 mg/kg bw. In the female rat, a oral discriminating does of 2000 mg/kg bw was estimated.

 

In a supporting study with the hydrolysis prodct of the test item a toxic class method according to OECD 423 was performed with 2,2-Dimethyl-3-lauroyloxy-propanal was conducted. Six female CRL:(WI) BR Wistar rats were treated with 2,2-Dimethyl-3-lauroyloxy-propanal by oral gavage (single application) at a dose level of 2000 mg/kg in sunflower oil. There was no mortality in the study. Based on these findings no further testing was performed. No clinical signs appeared after administration of 2,2-Dimethyl-3-lauroyloxy-propanal at 2000 mg/kg dose level. No effects on mean body weight and body weight gain were noted for these dose groups. Macroscopic alterations due to the toxic effect of the test item 2,2-Dimethyl-3-lauroyloxy-propanal were not found. Based on the results of this test. The acute oral LD50 of 2,2-Dimethyl-3-lauroyloxy-propanal was estimated to be greater than 2000 mg/kg bw in the rat.

Justification for classification or non-classification

Based on the results obtained from testing the test item was not classified and labelled with regard to acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP).