Di(morpholin-4-yl) disulphide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Di(morpholin-4-yl) disulphide

EC Number:

203-103-0

EC Name:

Di(morpholin-4-yl) disulphide

Cas Number:

103-34-4

Molecular formula:

C8H16N2O2S2

IUPAC Name:

4-(morpholin-4-yldisulfanyl)morpholine

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Initial boby weight = 210-240 g (males), 230-235 g (females)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

DTDM as a 20% suspension in corn oil was administered.

Doses:

3890, 5010, 6310 or 7940 mg/kg bw

No. of animals per sex per dose:

5 animals/dose

Control animals:

no

Details on study design:

Recovery period = 14 days.
Clinical signs of toxicity (activity, food consumption), mortality.. Gross autopsy.
Survivors were sacrified after fourteen days.

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 600 mg/kg bw

95% CL:

> 5 320 - < 5 880

Mortality:

Yes, see table
Time of mortality = one to four hours.

Clinical signs:

other: Clinical signs of toxicity included reduced activity and appetite for 3-5 days for survivors, and increasing weakness, collapse and death for decedents in 1-4 days.

Gross pathology:

Gross autopsy findings on decedents were lung and liver hyperemia and acute gastrointestinal inflammation. All viscera of survivors appeared normal.

Any other information on results incl. tables

Table of results

Dose mg/kg	Mortalities male	Mortalities female	Combined
3980	0/2	0/3	0/5
5010	1/3	0/2	1/5
6310	1 /2	2/3	3/5
7940	3/3	2/2	5/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, the LD50 (DTDM) was 5600 mg/kg in rats.

Executive summary:

In a pre-guideline acute oral toxicity study, male and female rats were exposed to 4,4 -Dithiodimorpholine at 3980, 5010, 6310 and 7940 mg/kg bw (single exposure), and were observed during 15 days. No mortality was observed at 3980 mg/kg, one rat died at 5010 mg/kg, 3 rats died at 6310 mg/kg and all five rats died at 7940 mg/kg. The LD50 was calculated to be 5600 mg/kg. Clinical signs observed in survivor rats were weakness, collapse, reduced food comsumption and reduced activity.