4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 23 Nov 1999 to 7 Dec 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP. The test material was similar to the registered substance but contained a higher proportion of an S3 isomer. The original study and the read-across are considered to be reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Referred to as 56706-10-6

IUPAC Name:

Referred to as 56706-10-6

Constituent 2

Reference substance name:

Multi-constituent substance; constituents 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane (CAS 56706-10-6), 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane (CAS 56706-11-7) and 4,4,12,12-tetraethoxy-3,13-dioxa-8-thia-4,12-disilapentadecane (CAS 60764-86-5)

IUPAC Name:

Multi-constituent substance; constituents 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane (CAS 56706-10-6), 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane (CAS 56706-11-7) and 4,4,12,12-tetraethoxy-3,13-dioxa-8-thia-4,12-disilapentadecane (CAS 60764-86-5)

Constituent 3

Reference substance name:

Low purity S2

IUPAC Name:

Low purity S2

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Charles River Labs, Raleigh, NC, USA

- Age at study initiation: 8 wk (m), 9 wk (f)

- Weight at study initiation: 293-315 g (m), 241-265 g (f)

- Diet (e.g. ad libitum): standard diet, ad libitum

- Water (e.g. ad libitum): drinking water, ad libitum

- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 71.4-72.1 deg F

- Humidity (%): 33.7-44.6

- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1999-11-24 To: 1999-12-07

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE

- % coverage: 18-23

- Type of wrap if used: gauze binder with non-irritating tape


REMOVAL OF TEST SUBSTANCE

- Washing (if done): wiped with moistened paper towel

- Time after start of exposure: 24 h


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 1.94 ml/kg bw (1.03 g/ml)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 (in dose groups)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: observations mortality twice daily, clinical changes daily, body weight days 0, 7, 14

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight

Statistics:

None given - limit test

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: No treatment-related effects.

Gross pathology:

No treatment-related effects detected.

Other findings:

- Other observations: eschar (scabbing or sloughing) in 3/10, resolved by day 10; desquamation (shedding of skin) in 6/10, resolved by day 14. No erythema or oedema.

Any other information on results incl. tables

Table 1: Number of animals dead and with evident toxicity

Dose (mg/kg bw)	Mortality (# dead/total)			Number with evident toxicity (#/total)
	Male	Female	Combined	Male	Female	Combined
2000	0/5	0/5	0/10	No systemic toxicity only local effects reported

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

From a reliable study conducted in compliance with the standard guideline and in accordance with GLP, no mortality or systemic effects were seen at 2000 mg/kg bw. The test substance was similar to the registered substance but contained a higher proportion of an S3 isomer.