Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
during April and May 1977 (no further details)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Principles of method if other than guideline:
No guideline is indicated. The method described is similar to the (now deleted) OECD 401.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
EC Number:
915-673-4
Cas Number:
211519-85-6
Molecular formula:
C18H42O6SxSi2
IUPAC Name:
Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Constituent 2
Chemical structure
Reference substance name:
4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
EC Number:
260-350-7
EC Name:
4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Cas Number:
56706-10-6
Molecular formula:
C18H42O6S2Si2
IUPAC Name:
4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Constituent 3
Reference substance name:
Polysulfides
IUPAC Name:
Polysulfides

Test animals

Species:
rat
Strain:
other: Sprague Dawley outbred strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: S. Ivanovas GmbH & Co, med. Versuchstierzuchten KG, Postfach 7, D-7964 Kißlegg/Allgäu, GERMANY
- Age at study initiation: 38 days (males), 42 days (females)
- Weight at study initiation: 100-105 g
- Fasting period before study: 15-16 h
- Housing: 1/Macrolon cage type II
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 0.5
- Humidity (%): 60 +/- 3
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated


IN-LIFE DATES: not stated - experimental work conducted during April and May 1977

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
none

MAXIMUM DOSE VOLUME APPLIED: 15.9 ml/kg bw
Doses:
10, 12.6, 15.9 ml/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 28 days
- Frequency of observations and weighing: frequency of clinical observations and body weight measurements not stated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15.9 mL/kg bw
Based on:
test mat.
Mortality:
No deaths in any group (see table 1).
Clinical signs:
No overt toxicity other than minor reduction in weight gain (see table 1).
Body weight:
Minor reduction in weight gain probably associated with slightly reduced food intake (see table 1).
Gross pathology:
No significant findings.
Other findings:
None.

Any other information on results incl. tables

Table 1: Number of animals dead or with evident toxicity

 Dose


(ml/kg bw)

Mortality (dead/total)

Reduced food intake

(mean %)

Reduced body weight development

(mean %)

Male

Female

Combined

Days 1,2,7

Days 1,2,7

10

0/10

0/10

0/20

6,4,0 

2,4,4, 

12.6

0/10

0/10

0/20

10,2,0 

4,4,6 

15.9

0/10

0/10

0/20

11,4,6 

 2,0,4

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable study conducted in a similar manner to a standard guideline but without GLP status identified an LD50 in excess of 15.9 ml/kg bw in male and female rats.

Categories Display