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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
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
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
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
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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 cpndition
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 month
- Weight at study initiation: 2013.3 - 2139.3 g (females)
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
up to 72 hours
Observation period (in vivo):
up to 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
The test substance was applied as a volume of 0.1 g/animal. the dose specified in the test guidelines for test substances. The eyes of the animals were examined one day prior to test substance administration.. On the day of treatment the test substance was applied into the concunctival sac of the left eye of each animal; then the lids were gently held together for about one second to prevent loss of the test substance. The right eye remained untreated and served as the reference control.
A single animal was treated first . As neither a corrosive effect nor a severe irritant effect was observed after the examinations the test was completed using the remaining animals.
The animals were observed in intervals for ui to 72 hours for clinical signs, mortality, changes in body weight and irritation effects on conjunctiva , iris, cornea and chemosis. Evaluation according to Draize 1944: J Pharmacol Exp Ther 82, 377-390
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: during the total observation period
Score:
0
Max. score:
4
Reversibility:
other: no corneal opacity
Irritation parameter:
iris score
Basis:
mean
Time point:
other: during the total observation period of 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: up to 24 hours post treatment
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: some blood vessels hyperemic
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: from 24 hours up to 72 hours
Score:
0
Max. score:
3
Reversibility:
other: no effects observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: some swelling above normal
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: from 1 hour up to 72 hours
Score:
0
Max. score:
3
Reversibility:
other: no effects observed
Irritant / corrosive response data:
after application of the test substance slight conjunctival redness (sore 1) and some chemosis above normal (score 1) was observed, but these effects were fully rversible within 48 hours.
Other effects:
no mortality, no clinical signs and all tested animals showed normal gains in body weight
Executive summary:

The acute eye irritation potential of Azo zinc complex pigment - melamine compound was investigated in 3 rabbits according to OECD TG 405 under GLP conditions. 100 mg of the test substance was applied into the conjunctival sac of the left eye of each of the 3 rabbits . The respective right eye served as control. The animals were observed in intervals up to 72 hours post application for clinical signs, mortality, body weight development and the treated eyes for effects on conjunctiva, cornea and iris.

No mortality was observed, no clinical signs related to treatment were noted; all animals showed normal gains in body weight. No corrosive effects were noted on the treated eye of any animal at any of the measuring intervals. No effects on iris and cornea were seen . Some hyperemic blood vessels (conjunctival injections, score 1) and some swelling above normal (score 1) was seen in each left eye of each of the 3 rabbits. But these effects were fully reversible within 48 hours

Based on these results Azo zinc complex pigment - melamine compound has to be evaluated as slightly irritating to the eyes which do not lead to classification or labelling

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

SKIN IRRITATION

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 observed for clinical signs, mortality, body weight development and the treated area for erythema and edema.

No mortality was observed, 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 animals 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

EYE IRRITATION

The acute eye irritation potential of Azo zinc complex pigment - melamine compound was investigated in 3 rabbits according to OECD TG 405 under GLP conditions. 100 mg of the test substance was applied into the conjunctival sac of the left eye of each of the 3 rabbits . The respective right eye served as control. The animals were observed in intervals up to 72 hours post application for clinical signs, mortality, body weight development and the treated eyes for effects on conjunctiva, cornea and iris.

No mortality was observed, no clinical signs related to treatment were noted; all animals showed normal gains in body weight. No corrosive effects were noted on the treated eye of any animal at any of the measuring intervals. No effects on iris and cornea were seen. Some hyperemic blood vessels (conjunctival injections, score 1) and some swelling above normal (score 1) was seen in each left eye of each of the 3 rabbits. But these effects were fully reversible within 48 hours

Based on these results Azo zinc complex pigment - melamine compound has to be evaluated as slightly irritating to the eyes which do not lead to classification or labelling


Justification for selection of skin irritation / corrosion endpoint:
There is only one study available which was performed according to OECD TG 404 under GLP condition therefore this study is evaluated with Klimisch score 1

Justification for selection of eye irritation endpoint:
There is only one study available which was performed according to OECD TG 404 under GLP condition therefore this study is evaluated with Klimisch score 1

Justification for classification or non-classification

Based on the available results there is no need to classify or label

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