Hydroxido potassium zirconium carbonate, where there are 0, 1 or 2 hydroxide groups and 2, 3 or 4 potassium atoms and 2, 3 or 4 carbonate groups.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 May 2002 to 20 May 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

A GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the submitted data. The study was conducted with a solution of potassium zirconium carbonate, rather than the pure solid, the results of the study are considered to be the worst case scenario since the solution has a higher pH (ca. 11 vs. 9.2). As such the results are considered to be reliable and suitable for addressing this endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Protocol Deviations:
- The animals were female instead of male
- Animal care and use committee approval number was 1188/02 instead of 1180/02 (a wrong approval number was written in the study plan)
- Fodder was changed to ensure animal wellbeing during the experiment
- Animal no BWA5 was weighed before dosing but not at the end of the observation period (human error)

None of the deviations were considered to affect the results of the study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium Zirconium Carbonate

IUPAC Name:

Potassium Zirconium Carbonate

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands, Horst
- Weight at study initiation: 2127 - 2339 g
- Housing: individually housed during study
- Diet : Lactamin K-5; Batch100 120 g/day (during study)
- Water: tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From 8 May 2002 to 20 May 2002

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- 0.1 ml undiluted test material was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second. The other eye, which remained untreated, served as a control.

Observation period (in vivo):

Observation period: 72 hours, however this period was extended for one animal up to day 5.

Following administration, animals were examined for signs of irritation/corrosion after 1, 24, 48 and 72 hours. Observation of ocular reaction was extended for one animal (after dosing) up to 5 days.

Tested animals were observed twice a day (morning and afternoon) for general well being. The animals were observed daily for clinical signs and all clinical signs were recorded.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation was not performed

SCORING SYSTEM: The scoring system presented in the standard guidelines OECD 405 'the grading of ocular lesions' was used to score the reactions observed (see Table 1 in field "Any other information on materials and methods" for further information)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 d

Score:

0

Max. score:

3

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 2 d

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 3 d

Score:

0

Max. score:

3

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Remarks:

5 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 d

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 2 d

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 3 d

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

The maximum score for each parameter was calculated using the scoring system presented in the Annex of OECD Guideline No. 405, and as included under the field "Any other information incl. tables".

Application of the test material into the eye caused a mild positive reaction in the conjunctivae tissue of all animals. All the eye reactions were reversible within 5 days. No reactions were observed in the control eye of any of the animals.

Other effects:

All animals survived in good condition during the study.

The body weight of the test animals was decreased during the observation period but it was considered unlikely to have been test item related.

Any other information on results incl. tables

Table 2: Summary of Eye Reactions

Cornea (score 0-4)	Time period (h)
Rabbit no.	1	24	48	72	Sum
BWE4	0	0	0	0	0
BWF6	0	0	0	0	0
BWA5	0	0	0	0	0
Sum	0	0	0	0
Mean	0	0	0	0
Iris (score 0-2)	Time period (h)
Rabbit no.	1	24	48	72	Sum
BWE4	0	0	0	0	0
BWF6	0	0	0	0	0
BWA5	0	0	0	0	0
Sum	0	0	0	0
Mean	0	0	0	0
Cunjunctivae (score 0-3)	Time period (h)
Rabbit no.	1	24	48	72	Sum
BWE4	0	0	1	0	1
BWF6	1	0	0	0	1
BWA5	1	0	0	0	1
Sum	2	0	1	0
Mean	0.67	0	0.33	0
Chemosis (score 0-4)	Time period (h)
Rabbit no.	1	24	48	72	Sum
BWE4	1	1	1	1	4
BWF6	0	1	0	0	1
BWA5	1	1	0	0	2
Sum	2	3	1	1
Mean	0.67	1	0.33	0.33

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material only elicited mild positive conjunctivae reactions in any of the animals during the course of the test that meant that the test material dose not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The eye irritation potential of the test material was determined in accordance with the standardised guidelines OECD 405. 0.1 ml of the test material was applied into one of each eye of three rabbits. The rabbits were observed for up to 5 days to determine the grade of ocular reaction to the test material. All tested animals had a mild positive reaction to the test material which were fully reversible within 5 days.

Under the conditions of the test, the test material was considered to be not irritating to the unrinsed eye. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.