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Toxicological information

Toxicity to reproduction

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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:
1963
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:
2007
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:
2007
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
Name:
Unnamed
Type:
Constituent

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 animals)

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