Registration Dossier

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
- no signs of systemic reaction to treatment
- no signs of skin irritation
Body weight:
- rats showed expected body weight gains
Gross pathology:
- no abnormal macroscopic findings at necropsy

Applicant's summary and conclusion