nonapotassium 2,4,6-trihydroxy-4-methyl-3,5-dioxa-2,4,6-trisilaheptane-2,6-bis(olate) 2,6,8-trihydroxy-4,6-dimethyl-3,5,7-trioxa-2,4,6,8-tetrasilanonane-2,4,8-tris(olate) 6-hydroxy-2,4,6-trimethyl-1,3,5,2,4,6-trioxatrisilinane-2,4-bis(olate) dihydroxy(methyl)silanolate {[dihydroxy(methyl)silyl]oxy}(hydroxy)methylsilanolate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 18, 2013 - January 13, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

further data not available

EC Number:

935-877-7

Cas Number:

31795-24-1

IUPAC Name:

further data not available

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: solid
- Colour: colourless
- Storage condition of test material: dry, at room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 9 - 10 weeks old; females: 12 - 13 weeks old
- Weight at study initiation: males: 258 – 269 g; females: 205 – 230 g
- Housing: full barrier in an air-conditioned room
- Diet (e.g. ad libitum): free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0801)
- Water (e.g. ad libitum): free access to tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): artificial light, sequence being 12 hours light, 12 hours dark

Administration / exposure

Type of coverage:

other: gauze-dressing and non-irritating tape

Vehicle:

cotton seed oil

Details on dermal exposure:

TEST SITE
- Area of exposure: uniformly over an area which was approximately 10% of the total body surface
- Type of wrap if used: dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed using cottonseed oil
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): single dose of 2000 mg/kg body weight
- For solids, paste formed: no

VEHICLE
- Lot/batch no. (if required): Sigma, lot no. MKBN8713V, expiry date: 31/01/2014

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

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 weighing: on day 1 (prior to the application) and on days 8 and 15
- Frequency of clinical examination: several times on day of dosing, thereafter once daily until end of observation period
- Necropsy of survivors performed: yes, gross necropsy

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 was observed.

Clinical signs:

other: No treatment-related signs of systemic toxicity or effects on organs were observed. Erythema grade 1 was observed in all animals. Oedema grade 1 was observed in 1 of 5 male animals. In all animals, green spots were observed at the application site 1 day

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which was due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, single dermal application of the test item to rats up at a dose of 2000 mg/kg body weight was associated with no mortality but signs of irritation. The dermal LD50 was determined to be > 2000 mg/kg body weight.
In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item has no obligatory labelling requirement for percutaneous toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item has no obligatory labelling requirement for percutaneous toxicity and is unclassified.
According to GHS (Globally Harmonized Classification System) the test item has no obligatory labelling requirement for percutaneous toxicity.