Registration Dossier
Registration Dossier
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EC number: 416-140-4 | CAS number: 145650-60-8 IRGAFOS 38
Neurotoxicity
Administrative data
- Endpoint:
- neurotoxicity: acute oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-04-18 to 1991-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (OECD Guideline 418)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 418 (Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure)
- Version / remarks:
- adopted on 04-Apr-1984
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- EC Number:
- 416-140-4
- EC Name:
- Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate
- Cas Number:
- 145650-60-8
- Molecular formula:
- C32H51 O3 P
- IUPAC Name:
- bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite
Constituent 1
Test animals
- Species:
- hen
- Strain:
- other: Leghorn hybrids
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
- Duration of treatment / exposure:
- 42 days
- Frequency of treatment:
- One oral dose by gavage. A second dose was be administered on day 21 after the first administration because no neurotoxic signs had been observed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- Negative control group: 4 hens
Positive control group: 4 hens
Test group: 8 hens - Control animals:
- yes
Examinations
- Positive control:
- Tri-orthocresyl phosphate (TOCP)
Results and discussion
Results of examinations
- Details on results:
- The test item administered orally in two doses of 2000 mg/kg bw did not produce clinical, macropathological or micropathological signs of neurotoxicity.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- other: Generation: maternal (migrated information)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
