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EC number: 701-028-2 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP and did not follow specific OECD test guidelines. However, it was an acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 961
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Type: other: Two generation study Method: other: see below
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
- EC Number:
- 701-028-2
- Cas Number:
- 26523-78-4
- Molecular formula:
- C45H69O3P
- IUPAC Name:
- 4-(2-methyloctyl)phenyl bis(4-nonylphenyl) phosphite
- Reference substance name:
- Nonylphenol
- EC Number:
- 246-672-0
- EC Name:
- Nonylphenol
- Cas Number:
- 25154-52-3
- IUPAC Name:
- 2-nonylphenol
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Duration of treatment / exposure:
- 2 years
Doses / concentrations
- Remarks:
- Doses / Concentrations:Designed to be equivalent to approximately 1000, 3300, and 10,000 ppm in the diet when the rats reached maturity (0, 50, 167, and 500 mg/kg/day) Basis:nominal in diet
- No. of animals per sex per dose:
- 200 weanling rats were distributed into four groups of 25 males and 25 females each.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- See discussion below.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3 300 ppm
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
Results: F1 generation
General toxicity (F1)
- Mortality / viability:
- mortality observed, treatment-related
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 3 300 ppm
- Based on:
- test mat.
- Remarks:
- (equivalent to 167 mg/kg/day)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on those results, indicating a possible effect at the dose of 500 mg/kg/d, a NOAEL from this study was 167 mg/kg bw/day (3300 ppmin diet).
- Executive summary:
Based on those results, indicating a possible effect at the dose of 500 mg/kg/d, a NOAEL from this study was 167 mg/kg bw/day (3300 ppmin diet).
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