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Toxicological information

Toxicity to reproduction

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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:
1982
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

Constituent 1
Chemical structure
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

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.