Phosphorothioic triamide, N-propyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April - May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes

Remarks:

(from the competent authority) Umweltministerium Baden-Württemberg

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide

EC Number:

700-457-2

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide

Details on test material:

- Name of test material (as cited in study report): LIMUS-Sambaydestillation
- Test-substance No.: 07/0684-1
- Physical state: solid/yellowish
- Analytical purity: 80-90%
- Lot/batch No.: 8712 / 062
- Storage condition of test material: < -18°C
- Stability: stable over 5 days

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:Wl (Han) SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks.
- Weight at study initiation: 239 - 283 g (males); 209 - 231 g (females)
- Housing: single housing in Makrolon cages, type III
- Diet (e.g. ad libitum): VRF1 (P); SOS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Remarks:

Ph. Eur.

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm2
- % coverage: 10%
- Type of wrap if used: semi occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2860 mg/kg b.w. (because the test-substance preparaton in a higher concentration was a paste, the preparation was not applicable in mL. The dosing for each animal has been provided in g by using a scale)
- Concentration (if solution): 70 g/100 mL (paste)
- Paste formed: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no macroscopic pathologic abnormalities noted

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no macroscopic pathologic abnormalities noted

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no macroscopic pathologic abnormalities noted

Mortality:

No mortality occurred.

Clinical signs:

other: No systemic clinical signs were observed during clinical examination. No local effects were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of LIMUS-Sambaydestillation after dermal application was found to be greater than 2000 mg/kg bw in male and female rats. Based on the results presented in this study, the test substances has not to be classified according to Directive 67/548/EEC and and GHS (UN) criteria.

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test substance (as suspension in olive oil Ph. Eur.) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

No mortality occured. Accordingly, the acute dermal median lethal dose (LD50) was determined to be

LD50, dermal, rat > 2000 mg/kg bw

No signs of systemic toxicity or skin effects were observed in the animals.

The mean body weight of the animals increased within the normal range throughout the study period.

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.