Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

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

Materials and methods

Principles of method if other than guideline:
LD50 determination in rats following dermal application.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Eucalyptus globulus, ext.
EC Number:
283-406-2
EC Name:
Eucalyptus globulus, ext.
Cas Number:
84625-32-1
Molecular formula:
Not relevant for a UVCB substance.
IUPAC Name:
1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
Test material form:
other: oil
Details on test material:
- Name of test material (as cited in study report): Eucalyptus oil

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
None

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
14 days
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals
Control animals:
no
Details on study design:
Animals were observed for mortality, clinical signs of toxicity and dermal reactions for 14 days.
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No
Body weight:
No data
Gross pathology:
No data
Other findings:
- Dermal reactions: slight redness (5/10 rabbits), moderate redness (3/10 rabbits) and moderate oedema (10/10 rabbits)

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 for eucalyptus oil is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
Executive summary:

In an acute dermal toxicity study, 10 rabbits were administered a single dermal dose of eucalyptus oil at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs of toxicity for 14 days.

No deaths and clinical signs of toxicity occurred during the observation period. Dermal reactions noted were slight redness (5/10 rabbits), moderate redness (3/10 rabbits) and moderate oedema (10/10 rabbits) at the site of application.

The dermal LD50 for eucalyptus oil is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).