2,8,9-Trioxa-5-aza-1-silabicyclo[3.3.3]undecane, 1,1'-(dithiodi-3,1-propanediyl)bis-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-12-16 - 2014-03-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study meets the guideline criteria and was conducted under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(the limit test was conducted with a dose level of 5000 mg/kg bw)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

477-700-1

EC Name:

-

Cas Number:

883794-93-2

Molecular formula:

Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2

IUPAC Name:

1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane

Constituent 2

Reference substance name:

Bis(2,8,9-Trioxa-5-aza-1-silabicyclo(3.3.3)undecane-1-propan e-)disulfide

IUPAC Name:

Bis(2,8,9-Trioxa-5-aza-1-silabicyclo(3.3.3)undecane-1-propan e-)disulfide

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males: 273-282 g, females: 190-247g
- Housing: individually in suspended, stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-29.1
- Humidity (%): 27-65
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap if used: self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing with water
- Time after start of exposure: at the end of exposure period of 24 hours

TEST MATERIAL
According to the body weight weighed before dosing, the theoretical amounts of test item were calculated. The test item was weighed on a gauze (5x5.5 cm) and was moistened sufficiently with the vehicle.

VEHICLE
- Lot/batch no. (if required): MKBF8603V

Duration of exposure:

24 hours

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

6 animals per sex and dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of clinical observations: once during first 30 min, and 1, 2, and 4 h after application and then once each day for at least 14 days
- Frequency of weighing: on day of dosing, Day 7 and 14 or at death.
- Necropsy of survivors performed: yes
- Clinical examinations included: animal fur changes, eyes and mucosa, respiratory, circulatory, nervous system, particularly limb activity and behaviour change, adverse skin reactions at the site of application daily according to the guideline score

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no death or moribund animals during the test.

Clinical signs:

other: There were no abnormal findings in all animals after dosing from the first day until the end of the test.

Gross pathology:

No abnormalities were found at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted according to OECD guideline 402 with GLP identified an LD50 of > 5000 mg/kg bw in both female and male rats.