(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one

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

Reference

Reference 1

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 2

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 3

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

Test material information

Constituent 1

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

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 / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
ca. 8 - 10 mg/kg bw/day
Basis:
nominal conc.
for P generation

Doses / concentrations 2

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.