4-[(morpholinothio)thioxomethyl]morpholine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 18 - April 23, 1980

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 40 CFR 163.81-1

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-[(morpholinothio)thioxomethyl]morpholine

EC Number:

237-335-9

EC Name:

4-[(morpholinothio)thioxomethyl]morpholine

Cas Number:

13752-51-7

Molecular formula:

C9H16N2O2S2

IUPAC Name:

morpholin-4-yl morpholine-4-carbodithioate

Details on test material:

Cure-Rite® 18, purity: not noted

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Animals from two suppliers were compared in this study
- Age at study initiation: 6 weeks
- Weight at study initiation: 109-202 grams
-Fasting period before study - approximately 18 hours
- Housing: Group house (6/cage) during equilibration. Individually housed during study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-8-days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69 - 75°F
- Photoperiod (hrs dark / hrs light): 12 dark/12 light

IN-LIFE DATES: From: 25 March 1980 To: 23 April 1980

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5 g/ml (50%)
- Purity: not recorded

MAXIMUM DOSE VOLUME APPLIED: 18.2 mL/kg bodyweight

Doses:

mg/kg

0, 25, 50, 100, 1800, 2700, 4050, 6075, 9112

No. of animals per sex per dose:

Doses 0-100 mg/kg - 10 animals per sex

Doses 1800-9112 mg/kg - 5 animals per sex

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days. 5 animals per sex in dose groups 0 to 100 mk/kg were held for 28 days
- Frequency of observations and weighing: Viability check - twice daily. Observation of Pharmacologic and Toxicologic signs made approximately 1,2 and 4 hours after dosing and daily thereafter for 14 daysand 28 days for 5 animals/sex in dose groups 0 to 100 mg/kg.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 200 mg/kg bw

Based on:

test mat.

95% CL:

4 200 - 6 200

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

95% CL:

4 800 - 6 200

Mortality:

Mortality due to the administration of test substance was not observed in the groups receiving doses of 25, 50 or 100 mg/kg.
0/10 rats died in the 1800 mg/kg dose group
1/10 rats died in the 2700 mg/kg dose group
1/10 rats died in the 4050 mg/kg dose group
9/10 rats died in the 6075 mg/kg dose group
8/10 rats died in the 9112 mg/kg dose group

Clinical signs:

other: other: 25 to 100 mg/kg dose groups: a clear ocular discharge for 2-4 hours post treatment. Several rats at 100 mg/kg displayed a motor activity decrease which was most marked at 4 hours. There were no delayed effects induced in those animals sacrificed a

Any other information on results incl. tables

Results for individual sexes/suppliers are shown below as mg/kg with 95% confidence limits:

Supplier 1:

Male 5000 (+/-1600), Female 5500 (+/-2500), Total 5200 (+/-1000)

Supplier 2:

Male 6100 (1300 +/-), Female 4.3 (1800 +/-), Total 5000 (+/-1200)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a study of the acute oral toxicity of Cure-Rite 18 to rats from two different sources of supply, total (male and female) LD50 values calculated were
5200 mg/kg and 5000 mg/kg. 95% confidence limits were +/- 1000 and +/- 1200 mg/kg respectively.

Executive summary:

5 groups of ten rats (five male and five female) were dosed at the following concentration: 1800, 2700, 4050, 6075 and 9112 mg test substance/kg bodyweight by oral gavage, then observation for mortality and clinical signs performed over a period of 14 days. At the end of the observation period, all animals were sacrificed and postmortem examinations performed. 0/10 rats died in the 1800 mg/kg dose group 1/10 rats died in the 2700 mg/kg dose group, 1/10 rats died in the 4050 mg/kg dose group, 9/10 rats died in the 6075 mg/kg dose group, 8/10 rats died in the 9112 mg/kg dose group. A considerable number of physical observations noted during the 14 day observation period. The most common findings were decreased respiratory rate and clear ocular, oral or nasal discharge.

The acute lethal oral dose to rats of Cure-rite 18 was found to be 5,000 mg/kg bodyweight for rats from 1 supplier and 5,200 mg/kg bodyweight for rats from a second supplier.