zinc, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes and melamine

Eye irritation

Administrative data

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

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

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 / tissue source

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Applicant's summary and conclusion

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