Registration Dossier
Registration Dossier
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EC number: 700-910-4 | CAS number: 1354201-99-2
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 July - 3 August 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Also in accordance with GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- O,O-bis(2-methylpropyl) sulfanidylphosphonothioate; trimethylazanium
- EC Number:
- 700-910-4
- Cas Number:
- 1354201-99-2
- Molecular formula:
- C11H28NO2PS2
- IUPAC Name:
- O,O-bis(2-methylpropyl) sulfanidylphosphonothioate; trimethylazanium
- Test material form:
- solid
- Remarks:
- pale yellow glassy solid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): S-10713
- Physical state: solid
- Colour: brown
- Storage condition of test material: at room temperature in the dark
- Lot/batch No.: S20227-179
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 232-260 g for males and 200-229 g for females
- Housing: individual during exposure and in groups during the rest of the study in solid-floor polypropylene cages furnished with woodflakes
- Diet: free access to 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK)
- Water: free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 20 July - 3 August 2011
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: moistened with distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of total body surface
- Type of wrap if used: surgical gauze semi-occluded with self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Deaths and clinical signs: 0.5, 1, 2 and 4 hours after dosing and daily thereafter
Irritation: after removal of the dressing and daily thereafter
Body weight: on day 0, 7 and 14
- Necropsy of all animals performed: yes - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No signs of systemic toxicity were observed.
- Gross pathology:
- No abnormalities noted.
- Other findings:
- No signs of dermal irritation were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 in Wistar rats was found to be >2000 mg/kg bw. The substance does not have to be classified according to EC Regulation 1272/2008.
- Executive summary:
An acute dermal toxicity study in rats was performed according to OECD 402 and EC 440/2008, B3, and following GLP principles. No mortality, clinical signs, signs of dermal irritation, effect on body weight, or abnormalities at necropsy were noted. The dermal LD50 in Wistar rats was found to be >2000 mg/kg bw.
The substance does not have to be classified according to EC Regulation 1272/2008.
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