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Registration Dossier
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EC number: 213-384-1 | CAS number: 941-98-0
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer- reviewd journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance raw materials monographs: α-Methyl Naphthyl Ketone
- Author:
- Moreno
- Year:
- 1 982
- Bibliographic source:
- Food and Chemical Toxicology. Vol. 20, Pg. 755, 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- Two-generation reproductive toxicity study of α-methyl naphthyl ketone in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1'-acetonaphthone
- EC Number:
- 213-384-1
- EC Name:
- 1'-acetonaphthone
- Cas Number:
- 941-98-0
- Molecular formula:
- C12H10O
- IUPAC Name:
- 1'-acetonaphthone
- Test material form:
- liquid
- Details on test material:
- -Name of test material: 1-(1-naphthyl)ethanone
- Molecular formula: C12H10O
- Molecular weight: 170.21 g/mol
- Smiles notation: c12c(cccc1C(C)=O)cccc2
- InChl: 1S/C12H10O/c1-9(13)11-8-4-6-10-5-2-3-7-12(10)11/h2-8H,1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data available
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Feed
- Details on exposure:
- No data available
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 months
- Frequency of treatment:
- Every other day
- Details on study schedule:
- No data available
Doses / concentrations
- Dose / conc.:
- 2 mg/kg diet
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- No data available
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- No data available
- Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- Reproduction were examined
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
Reproductive performance: No effects on reproduction of P generation were observed in treated rats at 2 mg.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 mg/kg diet
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- other: No effect on reproduction
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
Details on results (F1)
Reproductive performance: No effects on reproduction of F1 generation were observed in treated rats at 2 mg.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 2 mg/kg diet
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- other: No effect on Reproduction
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Details on results (F2)
Reproductive performance: No effects on reproduction of F2 generation were observed in treated rats at 2 mg.
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 2 mg/kg diet
- Based on:
- test mat.
- Sex:
- not specified
- Remarks on result:
- other: No effect on reproduction
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 2 mg/kg in P0, F1 and F2 generation when rats were treated with test material orally in diet for 8 months.
- Executive summary:
In a two generation reproductive toxicity study, rats were treated with test material in the concentration of 2 mg every other day in diet. No effects on reproduction of P, F1 and F2 generation were observed in treated rats at 2 mg. Therefore, NOAEL was considered to be 2 mg/kg in P0, F1 and F2 generation when rats were treated with test material orally in diet for 8 months.
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