Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.6302 (Color)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 830.6303 (Physical State)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.6304 (Odor)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Melaleuca alternifolia, ext.
EC Number:
285-377-1
EC Name:
Melaleuca alternifolia, ext.
Cas Number:
85085-48-9
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
IUPAC Name:
Essential oil of melaleuca alternifolia
Test material form:
liquid
Specific details on test material used for the study:
- Purity: 100%
- Lot (batch) No.: 1215
- Expiration date of the lot: 30 March 2009
- Storage condition of test material: Room temperature, protected from light.

Results and discussion

Physical state at 20°C and 1013 hPa:
liquid
Form / colour / odour
Form:
liquid
Colour:
Clear with a green/yellow tinge (closest match was 2.5 GY 9/2 on the Munsell system).
Odour:
other: antiseptic
Substance type:
natural substance

Applicant's summary and conclusion

Conclusions:
Tea Tree Oil is a clear colourless liquid at 20°C with a green/yellow tinge when observed in bulk and an antiseptic odour.
Executive summary:

A GLP-compliant study was carried out to determine the appearance, physical state and colour of Tea Tree Oil. The study followed the requirements of OPPTS method nos. 830.6302, 830.6303 and 830.6304 without significant deviation. Tea Tree Oil is a clear colourless liquid at 20°C with a green/yellow tinge when observed in bulk and an antiseptic odour.