2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

EC Number:

280-479-2

EC Name:

2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide

Cas Number:

83547-95-9

Molecular formula:

C30H57O7PS3

IUPAC Name:

2-ethylhexyl 2-{[bis({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)phosphoryl]sulfanyl}acetate

Test material form:

liquid

Details on test material:

- Other: Trade name D 16-051

Specific details on test material used for the study:

TEST MATERIAL (as stated in study report): TK 12 184

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 312-187

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house
- Age at study initiation: 7 - 8 weeks
- Fasting period before study: overnight
- Housing: groups of 5 in Macrolon cages (type 3)
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG, Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 deg C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

TK 12184 was suspended to achieve a concentration suitable for the dose levels selected for this test.
Volume (ml/kg body-weight): 10, 20

Doses:

1000, 2500, 5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were observed over a period of 14 days following dosing.
Bodyweights were recorded immediately prior to dosing and at 7 and 14 days.
All animals were submitted to a necropsy.

Statistics:

The LD50, including tne 95 % confidence limits were calculated by the logit model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 313 mg/kg bw

Based on:

test mat.

95% CL:

2 404 - 5 333

Mortality:

1000 mg/kg: no deaths
2500 mg/kg: 1 female
5000 mg/kg: 4 males and 5 females

Clinical signs:

Surviving animals recovered within 7 to 8 days

Gross pathology:

No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified by CLP criteria

Conclusions:

Under these standard test conditions, the acute oral LD50 of TK 12184 in rats of both sexes observed over a period of 14 days is 3313 (2404-5333) mg/kg.