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

Acute Toxicity: dermal

Administrative data

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

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 163.81-2 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

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: Gold colored viscous liquid

Details on test material:

Description: Gold colored viscous liquid

Test animals

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.

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.