Octanethioic acid, S-[3-(triethoxysilyl)propyl] ester, reaction products with 2-methyl-1,3-propanediol and 3-(triethoxysilyl)-1-propanethiol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Feb 2007 (Date of Project Protocol) - 11 Apr 2007 (Date of Report)

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 402 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Details on test material:

Colour: Light yellow

Specific details on test material used for the study:

Storage conditions: at room temperature

Test animals

Species:

rat

Strain:

Wistar

Remarks:

HsdRccHan : WIST rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen, Germany
- Weight at study initiation: 217-226g (male); 194-199g (female)
- Housing: the animals were kept in Macrolon cages on Altromin saw fiber bedding
- Diet: feeding ad libitum, Altromin 1324 (TPF)
- Water: free acces to tap water
- Acclimation period: adequate acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±10%
- Air changes: 10x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
- % coverage: approx. 10% of the total body surface
- Type of wrap if used: the test item was held in contact with the skin wih a cauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure (24 h), residual test item was removed by using tap water.

TEST MATERIAL
The test item was applied at a single dose (2000 mg/kg bw) by appling uniformly over an area which was approx. 10% of the total body surface.

Duration of exposure:

24 h

Doses:

single dose (2000 mg/kg bw) on an area which was approx. 10% of the total body surface

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were weighed prior to application and once a week thereafter.
- Necropsy of survivors performed: yes

A careful clinical examination was made at least twice on the day of dosing and once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and muscous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No treatment related effects were observed

Gross pathology:

No treatment related effects could be observed.

Other findings:

No treatment related effects were observed.

Any other information on results incl. tables

Weight Gain in g (dose: 2000 mg/kg)

Animal No. / Sex	Day 0	Day 7	Day 14
1 male	226	259	289
2 male	223	261	291
3 male	217	244	264
4 male	224	257	290
5 male	226	255	282
1 female	195	206	214
2 female	194	204	209
3 female	198	210	217
4 female	194	201	214
5 female	199	209	220

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an acute dermal toxicity study performed according to OECD/EC guidelines and GLP principles, the dermal LD50 was concluded to be >2000 mg/kg bw.