Registration Dossier
Registration Dossier
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EC number: 500-220-1 | CAS number: 68515-73-1
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: one generation screening study
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline study.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 110615-47-9
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- IUPAC Name:
- 110615-47-9
- Details on test material:
- - Name of test material (as cited in study report): APG, C12–C14 fatty alcohol, degree of polymerisation: 1.43
- Physical state: No data
- Analytical purity: No data
- Lot/batch No.: No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 weeks before pairing and continuously thereafter, up to the day before sacrifice (study day 53, day 4 post partum).
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Positive control:
- Not required.
Examinations
- Parental animals: Observations and examinations:
- According to Guideline.
- Oestrous cyclicity (parental animals):
- According to Guideline.
- Sperm parameters (parental animals):
- According to Guideline.
- Litter observations:
- According to Guideline.
- Postmortem examinations (parental animals):
- According to Guideline.
- Postmortem examinations (offspring):
- According to Guideline.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of a state-of-the-art reproduction/developmental toxicity screening testing according to the OECD guideline 421, no adverse effects were observed regarding male and female reproductive organs even at the very high dose of 1000 mg/kg bw/day.
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