Registration Dossier
Registration Dossier
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EC number: 918-205-7 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-07-17 to 1984-07-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-butyltriphenylphosphonium bromide
- EC Number:
- 918-205-7
- Cas Number:
- 1779-51-7
- Molecular formula:
- C22H24P.Br
- IUPAC Name:
- N-butyltriphenylphosphonium bromide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIf (SPF), F3-crosses of RII 1/TIF x RII 2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species: Rat, Tif:RAIf (SPF), F3-crosses of RII 1/TIF x RII 2/Tif
- Age at study initiation: approximately 7-8 weeks old
- Weight at study initiation: 183 - 215 g
- Fasting period before study: no
- Housing: 5 animals/sex/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure, pretreatement: Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- % coverage: no data
- Type of wrap if used: The required amount of the test substance was evenly dispersed on the skin. It was covered with a gauze lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): n.a.
- Constant volume or concentration used: n.a.
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): no data, however vehicle distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 was used in an amount sufficient to form a paste only
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Mortality/Viability: Twice daily on working days, once on weekend days
Body weights: Days 1 (pre-administration), 7, 14 and at death
Clinical signs: daily
Necropsy: Spontaneously dying animals were submitted to a group necropsy as soon as possible; survivors at the end of the observation period.
Observation period: 14 days - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No animal died.
- Clinical signs:
- other: Sedation on exposure day, dyspnoe from exposure day to post-exposure day 13, exopthalmus on post-exposure days 1-4, ruffed fur from exposure day to post-exposure day 12, ventral body posture from exposure day to post-exposure day 1 and curved body posture
- Gross pathology:
- No treatment-related deviations from normal morphology could be detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50 > 2000 mg/kg bw; classification criteria of REGULATION (EC) No 1272/2008 as well as of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations no met.
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