Registration Dossier
Registration Dossier
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EC number: 209-909-9 | CAS number: 597-82-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- O,O,O-triphenyl phosphorothioate
- EC Number:
- 209-909-9
- EC Name:
- O,O,O-triphenyl phosphorothioate
- Cas Number:
- 597-82-0
- Molecular formula:
- C18H15O3PS
- IUPAC Name:
- O,O,O-triphenyl thiophosphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hanlbm: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf/ Switzerland.
- Age at study initiation: Males: 8 weeks; Females: 11 weeks.
- Weight at study initiation: Males: 227-242 g; Females: 194-217 g
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding ("Lignocel", SchillAG, CH-4132 Muttenz). During treatment and observation individually in Makrolon type-3 cages with standard softwood bedding.
- Diet: Pelleted standard Kliba 343, batch no. 88/97 rat maintenance diet (Kliba Miihlen AG, CH-4303 Kaiseraugst) available ad libitum. Analysed for bacteriological, chemical and contaminant
- Water: ad libitum; tap water (analysed for bacteriological, chemical and contaminant)
- Acclimation period: One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3.
- Humidity (%): 40-70.
- Air changes (per hr): 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Backs of the animals.
- % coverage: Approximately 10 % of the total body surface.
- Type of wrap if used: Covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes; with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours.
TEST MATERIAL
Application volume/kg body weight: 2.0 mL. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg body weight.
- 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:
Mortality / Viability: Four times during test Day 1 and once daily for surviving animals during Days 2-15.
Body weights: On test Day 1 (pre-administration), 8 and 15 for surviving animals.
Clinical signs: Each animal was examined for changes in appearance and behaviour (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during Day 1, and once daily for surviving animals during Days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: Yes. - Statistics:
- No statistical analysis was used as no deaths occurred.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No signs of toxicity were observed.
- Gross pathology:
- No treatment-related macroscopic findings were observed.
- Other findings:
- Signs of toxicity (local): No skin irritation was observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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