Registration Dossier
Registration Dossier
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EC number: 201-224-3 | CAS number: 79-77-6
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable documented publication which meets basic scientific principles. Due to structural similarities of the registered substance trans-ß-ionone (CAS 79-77-6) and the used test substance (mixture of α- and β-isomers, CAS 8013-90-9) the data could be taken into account for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The toxicity of butyl acetate, methyl naphthyl ketone and ionone
- Author:
- Sporn A, Schobesch O, Marin V, Panaitescu E and Runcan L
- Year:
- 1 963
- Bibliographic source:
- IGIENA, 1963, 12(5), 437-446; also cited in the RIFM/FEMA database, location 16438
- Reference Type:
- secondary source
- Title:
- Fragrance material review on ionone
- Author:
- Lalko J et al.
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology 45 (2007) S251–S257
- Reference Type:
- secondary source
- Title:
- A toxicologic and dermatologic assessment of ionones when used as fragrance ingredients
- Author:
- Belsito D et al.
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology 45 (2007) S130–S167
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- treatment 8 months on alternate days
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Ionone
- EC Number:
- 232-396-8
- EC Name:
- Ionone
- Cas Number:
- 8013-90-9
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-1-en-1-yl)but-3-en-2-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: "white"
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: oil solution
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
- 2 mg ionone in 0.1 ml oil solution - Details on mating procedure:
- no further data given
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 8 months
- Frequency of treatment:
- on alternate days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
ca. 8 - 10 mg/kg bw/day
Basis:
nominal conc.
for P generation
- Remarks:
- Doses / Concentrations:
15 mg/kg bw
Basis:
nominal conc.
for F1 generation
- No. of animals per sex per dose:
- 48 animals divede into 4 groups
- Control animals:
- no
- Details on study design:
- - The female rats were studied through 3 reproduction cycles for number of pregnancies, weight, number of offspring, live pups, weight of pups at birth and after 7 and 21 days, and the viability of the pups after birth.
- The F1 generation (offspring) were allowed to reach maturity and treated with 15 mg/kg of ionone prior to being subject to reproductive toxicity testing.
- Their offspring, the F2 generation were evaluated for reproduction parameters.
Examinations
- Parental animals: Observations and examinations:
- OTHER: - number of pregnancies
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
- number of pups, live births, weight gain at day 7 and 21, viability
The following parameters were examined in F12 offspring:
- evaluation for reproduction parameters (not further specified)
GROSS EXAMINATION OF DEAD PUPS: no
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day
- Sex:
- not specified
- Basis for effect level:
- other: overall 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
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Ionone had no adverse effect on any of the parameters measured.
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.
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