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

Endpoint summary

Description of key information

Acute oral LD50 (rat)

Acute oral LD50 (hampster)

Acute dermal LD50 (rat)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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

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

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

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

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.

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.

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.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting 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

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:

yes

Specific details on test material used for the study:

TEST MATERIAL (as stated in study report): TK 12184

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. Mixt. 4/5/6

Species:

hamster, Chinese

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house
- Weight at study initiation: males - 32 g; females - 32 g
- Fasting period before study: overnight
- Housing: Indlvldually In Macrolon cages (type 2)
- Diet (e.g. ad libitum): NAFAG No. 923/924 NAFAG, Gossau SG, ad libitum
- Water (e.g. ad libitum): ad libitim
- Acclimation period: mlnlmum of 4 days

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

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

TK 12184 was suspended in distrilled water to achleve a concentratlon suitable for the dose levels selected.
Dosage volume: 10 mL/kg

Doses:

3000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Physlcal condltion and rate of deaths were monltored throughout the whole observatlon perlod.
Body welghts were recorded immedlately prlor to doslng and at 7 and 14 days.
All anlmals were submltted to a necropsy.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

All anlmals recovered wlthln 7 days.

Body weight:

Mean body weights decreased during the study.

Gross pathology:

No gross organ changes were observed.

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 Chinese hamsters of both sexes observed over a period of 14 days is >3,000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 313 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

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

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
- Weight at study initiation: males - 211 g; females - 195 g
- Housing: individually in Macrolon cages (type 2)
- Diet (e.g. ad libitum): NAFAG No. 890 NAFAG, Gossau S6, 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.

Duration of exposure:

24 h

Doses:

3000 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 after dosing.
Bodyweights were recorded immediately prior to dosing and at 7 and 14 days.
Animals were submitted to a necropsy at the end of the observation period.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

All animals recovered from systemic symptoms within 8 days.

Body weight:

Body weights increased during the study

Gross pathology:

No gross ogan changes were seen

Interpretation of results:

GHS criteria not met

Remarks:

Not classified by CLP criteria

Conclusions:

Under these standard test conditions, the acute dermal LD50 of TK 12 184 in rats of both sexes observed over a period of 14 days is greater than 3000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral LD50 (rat) = 3313 mg/kg

Acute oral LD50 (hampster) > 3000 mg/kg

Acute dermal LD50 (rat) > 3000 mg/kg

Justification for classification or non-classification

Based on the available data, TGEPO is not classified as according to Regulation (EC) No 1272/2008.