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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes

Test material

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

Applicant's summary and conclusion