O,O,O',O'-tetraoctyl-(branched and linear) S,S'-{methylenebis[imino(3-oxopropane-3,1-diyl)]} bis(phosphorothioate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 14 January 1985 and 5 February 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study using method similar to stated regulation including information on all key endpoint observations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: U.S. 40 CFR, Section 163.81-1, Federal Register August 22, 1978

Deviations:

not specified

GLP compliance:

yes

Test type:

other: Single dose

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid

EC Number:

700-945-5

Molecular formula:

Complex UVCB substance

IUPAC Name:

Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid

Test material form:

other: Brown viscous liquid

Details on test material:

Description: Brown visous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rats weighing 200-300 g were identified by ear punch and housed 5 animals per cage with each cage identifed by a cage card. Husbandry conditions were as follows: themperature 70 to 80 degrees F, relative humidity 55 +/- 25 %, light 12 hour light/dark cycle, diet Wayne Rodent-Blox and tap water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Single dose followed by a 14-day observation period

Doses:

5000 mg/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

Animals deprived of food but not water overnight before gavage dosing. Following administration animals were allowed food and water ad libitum for the 14-day observation period. Animals were observed frequently on the day of dosing and then twice a day thereafter (morning and afternoon). Individual weights were recoreded on the day of dosage, and average group weights were recorded on days 7 and 14 post exposure. Gross necropsies were performed on all animals that died or survived until termination at day 14.

Statistics:

Not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

No abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study classification of this substance for acute oral toxicity is not required under EU Regulation (EC) No. 1272/2008.

Executive summary:

Administration of this substance to male and female rats (5/sex/) to 5000 mg/kg did not cause any mortality, body weight changes, clinical observations or gross pathology abnormalities. Based on the results of this study classification of this substance for acute oral toxicity is not required under EU Regulation (EC) No. 1272/2008.