Registration Dossier

Administrative data

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

Data source

Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Cas Number:
Molecular formula:

Test animals

New Zealand White

Test system

Type of coverage:
Preparation of test site:
not specified
Amount / concentration applied:
0.5 g
Observation period:
1, 24, 48, 72 hours
Number of animals:

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: OECD GHS
Since the mean score of erythema and oedema did not qualify for any of the classification criteria, Tetrahydrocurcuminoids is classified as per the Harmonised Integrated Classification system (14 th August 2001) as "Not Irritant" to the rabbit skin.
Executive summary:

The acute Dermal Irritatino /Corrosion Study in Newzealand White Rabbits with Tetrahydrocurcuminoids was investigated according to OECD guideline No. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of a single male rabbit. As no severe skin reactions were observed after the 4 -hour exposure and thereafter till 48 hours (approximately), the test was completed using remaining two male rabbits for an exposure period of 4 hours.

The scoring of skin reactions were performed at 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item), for all the rabbits.

The test item did not elict any skin reaction at the application site of Animal No. 01 at 1 hour observation, revealed slight erythema at 24 and 48 hour observation and appeared normal at 72 hour observation. The test item did not elicit any skin reactions at the application site of Animal No. 02 and 03 at any of the observation time points. Oedema was not obseved in any of the treated animals at 1, 24, 48 and 72 hours observation. The individual mean score for erythema /eschar and oedema for each of the three male rabbits were therefore 0.67, 0.0, 0.0 and 0.0, 0.0, 0.0 respectively.

The application of Tetrahydrocurcuminoids to the skin did not result in severe signs of irritaion. The test item did not cause staining of the treated skin. No clinical signs were observed in any of the animals throughout the acclimatization as well as the observation period after treatment. Body weight of all animals considered within the normal range according to the species and strain.

At necropsy, no gross macroscopic abnormalitites were observed in Animal No. 01 and 02. In Animal No. 03, at the control site (right flank), 2 -3 foci (approx 4 mm) of epidermal ulceration with scab formation was observed. Since the lesion was observed in control site, this incidental and may not be due to the test item.