Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethyl]-.omega.-[2-[[2,2-dimethyl-3-[(1-oxododecyl)oxy]propylidene]amino]methylethoxy]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-28 to 2012-03-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 2002

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:

-

EC Number:

479-940-2

EC Name:

-

Cas Number:

613246-75-6

Molecular formula:

NA: Multi-const. substance

IUPAC Name:

16-(dodecanoyloxy)-2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-dien-1-yl dodecanoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl(WI)Br

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Age at study initiation: Young adult rats, 9 weeks old
-Weight at study initiation: 195-216 g
- Fasting period before study: food but not water was withheld overnight
- Housing: 3 animals/sex/cage
- Diet: ad libitum (ssniff® SM R/M-Z+H complete diet )
- Water: ad libitum
- Acclimation period: 12 days in first step and 13 days in second step

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Helianthi Annui Oleum Raffinatum

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/L
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: good solubity
- Lot/batch no.: 2011.03.04.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females/group
In total 2 groups with 3 females each were tested.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing 4 times every 7 day; Clinical observation- once during the first 30 min. , then 1h, 2h, 3h, 4h after treatment and on 14th day
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred at 2000 mg/kg single oral dose of the test item. All rats survived until the end of the 14-day observation period.

Clinical signs:

other: No treatment related symptoms were observed throughout the treatment and 14-day post-treatment period at any groups of the female animals.

Gross pathology:

All animals treated with 2000 mg/kg bw dose of the test item survived until the scheduled necrospy on day 15.
No pathological changes were found related to the effect of the test item during the macroscopic examination of the animals. Beside in animal no.: 2873 of the group 1 there were observed slight hydrometra connected to the cycle of the animal.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 obtained for the test item was found to be greater 2000 mg/kg bw.

Executive summary:

In this acute oral toxicity study, two groups of female rats (Crl(WI)Br) were given a single oral dose of the test item SIKA Hardener LJ at a concentration of 2000 mg/kg bw. The starting dose was selected on the basis of the available information about the test item.

The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Again, no animal died in the second step, thus no further testing was required. The stopping criteria of Annex 2d of OECD Guideline No. 423 were met.

Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment.

There were no effects on mean body weight and body weight gain. No clinical symptoms were observed and all organs of the animals treated with 2000 mg/kg bw dose proved to be free of treatment related gross pathological changes.

According of the results from this study the LD50 obtained for the test item was found to be o be greater 2000 mg/kg bw. Therefore, there is no classification required for the test item SIKA Hardener LJ.