Registration Dossier
Registration Dossier
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EC number: 700-457-2 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to GLP, OECD-guideline 402, Commission Regulation (EC) No 440/2008, US EPA OPPTS 870.1200 and Japan MAFF 8147.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar / 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 obs ervation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual ani mals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no macroscopic pathologic abnormalities noted
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no macroscopic pathologic abnormalities noted
- 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
- 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.
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