Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study under GLP conditions

Data source

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

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Azo zinc complex Pigment - Melamine compound
IUPAC Name:
Azo zinc complex Pigment - Melamine compound
Test material form:
other: brown powder
Details on test material:
Molecular weight 615.79
Lot no.BOS3479-3105
purity/content: 100 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 month
- Weight at study initiation: 1856.1 - 2007.1 g
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light) 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: moistened with the smallest amount of water to ensure good skin contact
Controls:
other: the opposite site of the back
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours post treatment
Number of animals:
3
Details on study design:
On the day prior to application the back of each rabbit was clipped free of hairs. The test substance was moistened with the smallest amount of water sufficint to ensure good skin contact.. Onto the one site of the back 0.5 g/site of prepared test substance was applied to a small area (approx 6cm² of skin and covered with a gauze patch, which is held in place with non-irritating tape. The entire trunk of the amimals were wrapped with mon-toxic adhesive tape for 4 hours. The applied sites were washed out gently with sterilized distilled water.
Test substance was applied sequentially to one animal, first patch for 3 minutes, second patch for one our and third patch for 4 hours
The confirmation test was conducted because corrosive effect was not observed in the initial test. 2 amimals were treated with a single patch which was removed after 4 hours.
Animals were observed for clinical signs, changes in body weight, and observations of application sites for erythema and edema for about 72 hours post treatment
Evaluation according to Draize 1944: J Pharmacol Exp Ther 82, 377-390

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: total observation period of 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: total observation period of 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Irritant / corrosive response data:
No corrosive effects were noted in the treated skin of any animals at any of the measuring intervals
After application of the test substance the dermal irritation was not shown in this study.
Other effects:
No mortality was observed; no treatment-related clinical signs. All tested animals showed normal gains in body weight

Applicant's summary and conclusion

Executive summary:

The acute dermal irritation potential of Azo zinc complex pigment - melamine compound was investigated in 3 rabbits according to OECD TG 404 under GLP conditions. 500 mg of the test substance was applied to the shaved skin and covered by semi-occlusive dressing for 4 hours. Up to 72 hours post application the animals were obsetved for clinical signs, mortality, body weight development and the treated area for erythema and edema.

No mortality was observedn no clinical signs related to treatment were noted; all animals showed normal gains in body weight.

No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals. After application of test substance the dermal irritation was not shown in this study.

Based on these results Azo zinc complex pigment - melamine compound is considered to be non-irritant to the skin