Pigment Yellow 214

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 07 SEP 1999 to 16 SEP 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 FEB 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

31 JUL 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Details on test material:

Batch: V.N0199.064
Expiry: 09.07.2001

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombres, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: females 14 weeks, males 15 weeks
- Weight at study initiation: male 2601 g, females 2548 and 2826 g
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintainance diet, ad libitum, haysticks provided by Eberle Nafag AG, CH-9200 Gossau
- Water: Community tap water, ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal

Duration of treatment / exposure:

test substance was not removed from the eye

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

1 male, 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: The occular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 32, 1992.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Slightly reddened conjunctivae was observed in all three animals 1 h after application. The effect remained in one animal at the 24 hour reading, but was fully reversible within 48 h.
One hour after instillation one animal showed also slight chemosis (score 1).

Other effects:

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortalities ocurred. Yellow remnants in eye or conjunctival sac and around eye and /or on lids by the test article were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not induce significant or irreversible damage to the rabbit eye in this study according to OECD test guideline no. 405 and GLP conditions.

Executive summary:

The eye irritating potential of the test item was assessed according to OECD TG 405. Three rabbits were exposed to 0.1 mg test item. The mean score was calculated across three scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals.

The individual mean scores for the conjunctivae were 0.00, 0.00 and 0.33 for reddening and 0.00, 0.00 and 0.67 for chemosis for all animals, respectively. One hour after instillation all treated animals showed slight conjunctival redness (score 1) and one animal showed also slight chemosis (score 1). All effects were fully reversible within 72 h.