Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,7-bis(4-hydroxy-3-methoxyphenyl)heptane-3,5-dione
Cas Number:
36062-04-1
Molecular formula:
C21H24O6
IUPAC Name:
1,7-bis(4-hydroxy-3-methoxyphenyl)heptane-3,5-dione

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Controls:
yes
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
1

Results and discussion

In vivo

Results
Remarks on result:
other: Information provided in study report

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Since the outocome of the result did not qualify for any of the category of the classification criteria, Tetrahydrocurcuminoids is classified as per the Harmonized Integrated System (14th August 2001) as "Not irritating" to the rabbit eye.
Executive summary:

the acute eye irritation /corrosion study of Tetrahydrocurcuminoids in Rabbits was investigated according to OECD test guideline 405. The test item, 54 mg (0.1 ml) was placed in the conjunctival sac of the left eye of a single male rabbit. as no severe eye reactopms were pnserved after tje 48 -hour exposure, the test was completeted using remaining two male rabbits for an exposure of 24 hours.

The scoring of eye reactions was performed at 1, 24, 48 and 72 hours, after test, item administration, for all the rabbits.

The mean score was calculated across 3 scoring time points (24, 48 and 72 hours after administration) for each animal for corneal opacity, iri, conjunctivae and chemosis. the individual mean score of opacity, iris, conjunctivae and chemosis for Animal No. 01, 02 and 03 were 0.00, 0.00, 0.00 and 0.00 respectively.

The administration of Tetrahydrocurcuminoids into te eyes of the rabbitts did not produce any irritation or corrosion till 72 hours after exposure. The observation was terminated at 72 hour since, there were no reactions observed in any of the animals. the test item did not cause staining of the treated eye. No clinical signs were observed throughout the acclimatization as well as the observation period after treatment. At necropsy, no abnormality detected from any of the treated animals.