Registration Dossier
Registration Dossier
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EC number: 272-574-2 | CAS number: 68890-66-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Octorirox
- IUPAC Name:
- Octorirox
- Reference substance name:
- Piroctone Olamine
- IUPAC Name:
- Piroctone Olamine
- Reference substance name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- EC Number:
- 272-574-2
- EC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Cas Number:
- 68890-66-4
- Molecular formula:
- C14H23NO2.C2H7NO
- IUPAC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Reference substance name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
- IUPAC Name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 202 - 219 g (male animals); 192 - 208 (female animals)
- Diet (e.g. ad libitum): Altromin 1324 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 30 cm2
- % coverage: 100
- Type of wrap if used: elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (male animals); 21 days (female animals)
- Frequency of observations and weighing: Daily observations; weighinh once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Unspecific clinical symptoms (reduced spontaneous activity; uncoordinated gait) until day 1 p.a.
- Gross pathology:
- No macroscopic visible changes
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Not subject for labelling and classification Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose (LD50) of piroctone olamine is greater 2000 mg/kg body weight in male and female rats.
- Executive summary:
Testing of the acute dermal toxicity of Octopirox in Wistar rats revealed a median lethal dose (LD50) in male and female animals of over 2000 mg/kg body weight. No deaths occurred after application of the limit dose of 2000 mg/kg body weight. After removal of the occlusive dressing, the animals displayed reduced spontaneous activity. These symptoms were reversible two days after application onwards. There were also severe irritant effects on the treated surface of the skin. Body weight development was not significantly impaired. Gross pathology of the animals showed no macroscopically visible changes.
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