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

Endpoint summary

Description of key information

Oral LD 50 > 5000 mg/kg 
Dermal LD 50 > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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:

Between 29 August 1985 and 12 September 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted using method similar to existing guideline with none or minor deficiencies

Qualifier:

equivalent or similar to guideline

Guideline:

other: U.S. 40 CFR Section 163.81-2 Federal Register August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of November 1982

Deviations:

not specified

Principles of method if other than guideline:

A group of 10 rabbits (5/sex) with health intact skin was used. Approximately 24 hours before testing, the fur was clipped from their back and weighed. A dose of 2000 mg/kg was applied to approximately 10% of the body surface area of each animal. The treated area was covered with a large porous gauze patch and wrapped with an impervious material. Dressings were removed after 24 hours and any excess material was removed as practical using water or an appropriate solvent. Animals were observed for systemic and local signs of toxicity and for mortality frequently during the first day of dosing and twice per day (morning and afternoon) on weekdays and once per day on weekends and holidays through day 14 post exposure. Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. Gross pathological evaluation was conducted on all animals.

GLP compliance:

yes (incl. QA statement)

Test type:

other: Single dose

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animals house in stainless steel cages with elevated wire mesh flooring (1/cage), were acclimated 5 days prior to testing and individually identified by an ear tag. Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne 15 % Rabbit Ration and tap water ad libitum.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

A group of 10 rabbits (5/sex) with health intact skin was used. Approximately 24 hours before testing, the fur was clipped from their back and weighed. A dose of 2000 mg/kg was applied to approximately 10% of the body surface area of each animal. The treated area was covered with a large porous gauze patch and wrapped with an impervious material. Dressings were removed after 24 hours and any excess material was removed as practical using water or an appropriate solvent. Animals were observed for systemic and local signs of toxicity and for mortality frequently during the first day of dosing and twice per day (morning and afternoon) on weekdays and once per day on weekends and holidays through day 14 post exposure. Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. Gross pathological evaluation was conducted on all animals.

Duration of exposure:

24 hours

Doses:

Single dose, 2000 mg/kg

No. of animals per sex per dose:

10 animals (5/sex)

Control animals:

no

Details on study design:

A group of 10 rabbits (5/sex) with health intact skin was used. Approximately 24 hours before testing, the fur was clipped from their back and weighed. A dose of 2000 mg/kg was applied to approximately 10% of the body surface area of each animal. The treated area was covered with a large porous gauze patch and wrapped with an impervious material. Dressings were removed after 24 hours and any excess material was removed as practical using water or an appropriate solvent. Animals were observed for systemic and local signs of toxicity and for mortality frequently during the first day of dosing and twice per day (morning and afternoon) on weekdays and once per day on weekends and holidays through day 14 post exposure. Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. Gross pathological evaluation was conducted on all animals.

Statistics:

None, not applicable.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Mild erythema and severe edema was noted in males and females after unrapping at 24 hours. In males no erythema or edema was noted at day 14 termination. In females sight erythema was still noted in 2/5 animals. Diarrhea was observed in one mal (days 11

Gross pathology:

None

Other findings:

No measurable residual test material was left on the backs after removal following the 24 hour exposure period.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on EU CLP Regulation No. 1272/2008 this product is not classified for acute dermal toxicity and there is no evidence of specific organ toxicity.

Executive summary:

A group of 10 rabbits (5/sex) with health intact skin was used. Approximately 24 hours before testing, the fur was clipped from their back and weighed. A dose of 2000 mg/kg was applied to approximately 10% of the body surface area of each animal. The treated area was covered with a large porous gauze patch and wrapped with an impervious material. Dressings were removed after 24 hours and any excess material was removed as practical using water or an appropriate solvent. Animals were observed for systemic and local signs of toxicity and for mortality frequently during the first day of dosing and twice per day (morning and afternoon) on weekdays and once per day on weekends and holidays through day 14 post exposure. Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. Gross pathological evaluation was conducted on all animals.

No mortality or gross abnormalities were noted. Mild erythema and severe edema was noted in males and females after unrapping at 24 hours. In males no erythema or edema was noted at day 14 termination. In females sight erythema was still noted in 2/5 animals. Diarrhea was observed in one mal (days 11 and 12) and one female (day 7). A loss of body weight was noted in two males (days 7 and 14) and one female at day 7 and two females at day 14. No measurable residual test material was left on the backs after removal following the 24 hour exposure period.

Based on EU CLP Regulation No. 1272/2008 this product is not classified for acute dermal toxicity and there is no evidence of specific organ toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Oral toxicity

Oral 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.

Dermal toxicity

A group of 10 rabbits (5/sex) with health intact skin was used. Approximately 24 hours before testing, the fur was clipped from their back and weighed. A dose of 2000 mg/kg was applied to approximately 10% of the body surface area of each animal. No measurable residual test material was left on the backs after removal following the 24 hour exposure period. Based on EU CLP Regulation No. 1272/2008 this product is not classified for acute dermal toxicity and there is no evidence of specific organ toxicity.

Justification for classification or non-classification

Under the test conditions, the acute oral and dermal LD50 of test item are higher than 2000 mg/kg bw in vivo, therefore, it is not classified according to CLP Regulation (EC) No. 1272/2008.