Registration Dossier
Registration Dossier
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EC number: 423-340-5 | CAS number: 162881-26-7 CGI 819
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was conducted according to EU Method in compliance with GLP.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
- EC Number:
- 423-340-5
- EC Name:
- Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
- Cas Number:
- 162881-26-7
- Molecular formula:
- C26H27O3P
- IUPAC Name:
- [phenyl(2,4,6-trimethylbenzoyl)phosphoryl](2,4,6-trimethylphenyl)methanone
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 1% Methylcellulose
- Details on oral exposure:
- Method of administration: gavage
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Clinical observations: There were no clinical observations noted that could be indicative of treatment to the product. One female died in week 1 of an intubation error. This death considered to be accidental.
Laboratory findings: Neutrophils were increased in top dose males. Decreases in alkaline phosphatase and AST were seen in top dose males and mid and top dose females, respectively. All were normal after 2 weeks recovery.
Effects in organs: No treatment-related gross or microscopic changes were observed.
Applicant's summary and conclusion
- Conclusions:
- Classified as: not classified.
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