Reaction mass of Octadec-9-en-1-yl ammonium di-n-hexyl phosphorodithioate and Octadec-9-en-1-yl ammonium mono- and di-butylphosphate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted between February 7, 1985 and February 21, 1985.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study

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:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadec-9-en-1-yl ammonium mono and di-butylphosphate

Molecular formula:

C22H48NO4P - C26H56NO4P

IUPAC Name:

Octadec-9-en-1-yl ammonium mono and di-butylphosphate

Constituent 2

Reference substance name:

Octadec-9-en-1-yl ammonium di-n-hexyl phosphorodithioate

Molecular formula:

C30H64NO2PS2

IUPAC Name:

Octadec-9-en-1-yl ammonium di-n-hexyl phosphorodithioate

Test material form:

liquid: viscous

Details on test material:

Material is a yellow viscous liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Young adult male and female Sprague-DawleyR Crl :CDR (SD ) BR rats, supplied by Charles River Breeding Laboratories, Inc., Wilmington,
Massachusetts, were used in this study. They were received on January 15, 1984 and allowed a conditioning period of 23 days prior to dosing in our laboratory.

The males were 73 days of age and weighed 337 -355 grams, and the females were 80 days of age and weighed 210-243 grams at the time of dosing.

The animals were housed individually in wire-bottom cages in an airconditioned room. The temperature ranged from 21.l-22.6°C and the relative humidity from 26.4-59.7% during the study. The photoperiod was a 12 -hour light/dark cycle: lights on at 0630 and off at 1830. The animals had free access to Purina Laboratory Rodent ChowR #5001 and water.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The fur on the trunks of five animals of each sex was clipped on the day prior to dosing. Two grams of the test material per kilogram of body weight were applied to the trunk of each animal. The material was held in contact with the animal's skin by a plastic sheet. ElastikonR was wrapped around the trunk of the animal to secure the plastic and ensure that the animal could not ingest the test material. The mean volumes (+/-S.D.) of test material administered were 0.73 (0.01) ml for males and 0.48 (0.03) ml for females; the mean weights (+/-S.D.) of test material administered were 0.69 (0.02) g for males and 0.46 (0.03) g for females. Five clipped, untreated animals of each sex were wrapped as described above and served as sham controls. The animals were dosed and wrapped approximately nine hours after the onset of the light cycle.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

Fave males, five females

Control animals:

yes, concurrent no treatment

Details on study design:

After a 24-hour exposure period, the wrappings were removed from the animals. Any remaining test material was wiped off with a sterile gauze pad. Collars were placed on treated animals for 24 hours to prevent oral ingestion of residual test material and on controls for the same length of time. The animals were observed frequently for any physiological or behavioral abnormalities on the day of dosing and at least once each weekday morning and late afternoon for 13 days after treatment; on weekends, they were observed once daily. On Day 14, the animals were observed once prior to sacrifice. The skin at the application site was scored for irritation at 1, 7, and 14 days after treatment using the modified scoring system of Draize.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Red ocular and nasal discharges were observed in several treated animals during the first week after dosing. By Day 5, all treated sites had thickened, hardened, and scabbed skin. The necrotic skin sloughed in some animals to reveal scabbed, relatively sm

Gross pathology:

At necropsy on Day 14, all treated males showed relatively smooth skin with scabs. While several treated females also showed areas of smooth but scabbed skin, all treated females had flaky, dry, brown, sloughing, thickened, hard, and/or leatherlike skin. No other gross pathological changes were observed.

Histopathological evaluation of treated skin sections showed acanthosis, necrosis and ulceration, scab formation, and surface exudate. These results indicate that XA 289M is a severe irritant.

Other findings:

Skin Irritation
XA 289M caused severe erythema with well-defined edema in males and no to slight erythema with no edema in females 24 hours after dosing. Seven days after dosing, all treated skin was thickened, hardened, and/or scabbed. Edema was indeterminable in most animals. By the 14-day reading, necrotic skin had partially or completely sloughed to reveal scabbed, relatively smooth skin with no to slight edema.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU