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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, animal experimental study, notable limitations in design and/or reporting but adequate for assessment (also see attached document)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Composition: 55-90% alpha-isomethylionone (CASnr 127-51-5), 5-25% n-alphamethylionone (CASnr 7779-30-8)

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data on sex and strain were available

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
no data on type of coverage were available
Duration of exposure:
no data on duration of exposure were available
Doses:
5 g/kg
No. of animals per sex per dose:
8 animals per dose
Control animals:
no
Details on study design:
Duration of observation period following administration: 14 days
Statistics:
no

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
Skin irritation:
Slight redness: 2/8
Moderate redness: 4/8

Applicant's summary and conclusion