Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 - 27 Oct 2011

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:

adopted Feb 2002

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:

not specified

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

not specified

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, No 8147

Version / remarks:

Nov 2000

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Remarks:

Food and Consumer Product Safety Authority (VWA), Utrecht, The Netherlands

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane

EC Number:

300-346-5

EC Name:

Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane

Cas Number:

93925-43-0

Molecular formula:

C4H8O2, C20H44O4SiSn, C24H52O6SiSn, C40H84O8SiSn2, C60H128O12Si2Sn3, C80H172O16Si3Sn4, C100H216O20Si4Sn5

IUPAC Name:

Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle and test substance. In order to obtain homogeneity, the test substance formulations were heated in a water bath with a maximum temperature of 79.1ºC for a maximum of 40 minutes. The test substance formulations were allowed to cool down to a temperature of maximally 40ºC prior to dosing.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han) (outbred, SPF-Quality)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation: group 1: 171 ± 22 g; group 2: 183 ± 10 g
- Fasting period before study: animals were fasted overnight prior to administration of the test substance
- Housing: group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material and paper as cage enrichment.
- Diet: SM R/M-Z, pelleted, (Ssniff Spezialdiäten GmbH, Soest, Germany),ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 19.3 – 21.2)
- Humidity (%): 40 - 70 (actual range 44 - 73)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: dehydrated corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 females dosed per step in 2 steps)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed twice daily for mortaility; individual body weights were determined on days 1 (pre-administration), 8, 15 and prior to sacrifice.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

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 mortality occured during the study period.

Clinical signs:

other: Hunched posture was observed in 6/6 animals on Day 1-2, and recurred in 6/6 animals on Day 5 or 7, persisting until Day 11 in 5/6 and until Day 14 in 1/6. Piloerection was noted in 3/6 animals on several or all days in the period from Day 7-11. A lean ap

Gross pathology:

No substance-related findings.

Any other information on results incl. tables

Table 1 Clinical signs

Test Days	1	1	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15
Hours after dosing	0	2	4
Animal 1
Hunched posture	-	1	1	-	-	-	-	-	1	1	1	1	1	-	-	-	-
Animal 2
Hunched posture	-	1	1	-	-	-	-	-	-	-	1	1	1	-	-	-	-
Animal 3
Hunched posture	-	1	1	1	-	-	-	-	-	-	1	1	1	-	-	-	-
Animal 4
Hunched posture	1	1	1	1	-	-	1	1	1	1	1	1	1	1	1	1	-
Piloerection	-	-	1	-	-	-	-	-	1	1	1	1	1	-	-	-	-
Lean	-	-	-	-	-	-	-	-	-	1	1	1	1	1	1	1	-
Animal 5
Hunched posture	1	1	1	1	-	-	-	-	1	1	1	1	1	-	-	-	-
Piloerection	-	-	-	-	-	-	-	-	1	1	-	-	1	-	-	-	-
Animal 6
Hunched posture	1	1	1	1	-	-	1	1	1	1	1	1	1	-	-	-	-
Piloerection	-	-	-	-	-	-	1	1	1	1	-	-	-	-	-	-	-
Lean	-	-	-	-	-	-	-	-	-	1	1	1	1	-	-	-	-

1 = Max Grade of clinical signs

Table 2 Body weights (gram)

Days	1	8	15
Animal 1	146	146	175
Animal 2	188	200	215
Animal 3	178	197	203
Mean ± SD	171 ± 22	181 ± 30	198 ± 21
Animal 4	181	151	170
Animal 5	194	201	216
Animal 6	174	158	201
Mean ± SD	183 ± 10	170 ± 27	196 ± 23

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified