Alkane-alpha,omega-diyl bis{[(triethoxysilyl)propyl]carbamate}_E2

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-01-23 to 2015-02-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

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:

(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:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(2010)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

other: liquid

Details on test material:

Reaction mass of 2,2,4-trimethylhexane-1,6-diylbis{[3-(triethoxysilyl)propyl]carbamate} and 2,4,4-trimethylhexane-1,6-diylbis{[3-(triethoxysilyl)propyl]carbamate} manufactured by Evonik Degussa GmbH. Batch No. IPES-Addukt 7W of 2014-06-23, purity: 95.05.%.

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at start of administration: Approx. 8 weeks
- Weight at start of administration: 162 - 179 g
- Fasting period before study: approx. 16 hours
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus). Granulated
textured wood was used as bedding material for the cages.
- Diet:Commercial diet, ssniff® R/M-H V1534 (Certificates of analysis provided) ; discontinued approx. 16 hours before administration
- Water: tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light (about 150 lux at approx. 1.50 m room height)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Vehicle: The test item was used as supplied.
The administration volume was 1.92 mL/kg b.w. as the density amounted to 1.04 g/mL.
Dose level: 2000 mg/kg b.w. (limit test)

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit test at one dose level of 2000 mg/kg bw was carried out on 6 female animals

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours
after administration. All surviving animals were observed for a period of 14 days. Individual body weights were recorded before administration
of the testsubstance and thereafter in weekly intervals up to the end of the study.

- Necropsy of survivors performed: At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross
pathological changes were recorded.

- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory,autonomic and central
nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter
each working day. Any tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma were also noted.

Statistics:

No statistical analysis was performed as the method used is not intended to allow a calculation of a precise LD50 value.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 24 hrs and 14 days

Mortality:

No death was recorded within the test period.

Clinical signs:

other: Under the present test conditions, a single oral administration of 2000 mg test item/kg b.w. did not reveal any clinical signs of toxicity.

Gross pathology:

No pathological changes were observed at necropsy.

Other findings:

- Histopathology:
No histopathology was carried out as no macroscopical findings were noted at autopsy.

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Conclusions:

In this acute oral toxicity study in rats (limit test), the LD 50 (females) for the test item was > 2000 mg/kg bw.

Executive summary:

The test item was given to rats by a single oral administration to obtain information on the toxicity, in particular lethality, of the test item. The Acute Toxic Class Method was employed to establish the required information for hazard assessment and hazard classification.

In this experiment the test item was examined for acute toxicity after a single oral administration to rats.

Under the present test conditions, a single oral administration of 2000 mg test item/kg b.w. did not reveal any clinical signs of toxicity.

All animals gained the expected body weight at the end of the study period.

No pathological changes were observed at necropsy.

The LD₅₀value was ranked exceeding 2000 mg/kg b.w..

Test item
LD50[mg/kg b.w., oral]
24 hours	14 days
females	females
> 2000	> 2000