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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study, acc. to GLP. 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 Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Limit test:

yes

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

Details on test material:

- Name of test material (as cited in study report): IONONE PURE 100% (TEST NO. 1999015)
- Physical state: extremely pale yellow liquid
- Analytical purity: sum of isomeres >= 85%
- Isomers composition: 61,8% trans-alpha Ionon, 25-35% beta-Ionon
- Batch No.: 29080039
- Storage condition of test material: approximately 4°C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 230-261 g (males), 214-231 g (females)
- Housing: in polypropylene cages furnished with woodflake individually during exposure period, then in groups of 5 by sex
- Diet: standard rat diet (Rat and Mouse SQC Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

10 Sprague Dawley CD (Crl:CD (SD) IGS BR) rats (5/sex) had their fur clipped on their backs and flanks. One day later, 2000 mg/kg bw of undiluted test substance was applied on an area of approx. ~10% of the total body surface and covered with a piece of surgical gauze which was held in place with a piece of self-adhesive bandage. After 24 hours, the gauze was removed and the area was wiped with water-moistened cotton wool to remove residual test material.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Rats were observed at frequent intervals (0.5, 1, 2, and 4 hours post dosing) on day 0 (day of dosing) and once daily thereafter for clinical signs.
- Body weight was recorded on Days 0 (pre-treatment), 7 and 14.
- The skin reactions were numerically graded daily for erythema and eschar formation [0 (no erythema) to 4 (severe erythema to slight eschar formation)] and edema [0 (no edema) to 4 (severe edema)].
- All rats surviving to the end of the observation period were killed by cervical dislocation and examined macroscopically (i.e., opening of the abdominal and thoracic cavities).
- An estimate of the acute dermal median lethal dose (LD50) was made.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

- no deaths

Clinical signs:

other: - no signs of systemic reaction to treatment - no signs of skin irritation

Gross pathology:

- no abnormal macroscopic findings at necropsy