Phosphinate1030

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr - May 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 2.3 - 3.7 kg
- Housing: in separate cages
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 27.04. To: 18.05.2004

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The eye remained untreated and was used for control purposes.

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

24 h after administration the treated eyes were washed out with isotonic saline at approx. 37°C

Observation period (in vivo):

1 hour and 24, 48 and 72 hours as well as 7 and 14 days following treatment
At 24 and 72 hours and after 7 and 14 days, the eyes were further examined for corneal lesions under UV light after instillation of one drop of 0.01 % Fluorescein-sodium

Number of animals or in vitro replicates:

3

Details on study design:

Test Item Administration:
The test item was applied as a weight of 0.1 g/animal, the dose specified in the test guidelines for solid test items.

An initial test was performed using one animall.

As neither serious eye damage nor severe effect were observed in the initial test a confirmatory test with two further animals was performed.

About 24 h before the stert of the study both eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalies were used for the study. 0.1 g of the test item was administered once to the conjuntival sac of the left eye of three rabbits. In each case the untreated eye served as control.

24 h after administration the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

Rationale: No study on eye irritation was available. The test item is not classified as corrosive or irritating to skin.

Observations

Viability / Mortality: Daily
Clinical Signs: Daily
Eye Reactions: See below
Body Weights: At start of acclimatization, on test day 1 and at termination of observation.

Assessment of Eye Reactions:

The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, at approximately 1, 24, 48 and 72 hours, as well as 7 days after administration. Scleral reddening and ocular discharge were also assessed. Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland)

Data was summarized in tabular form, showing for each animal the irritation scores for the designated observation time, a description of the degree and nature of irritation, the presence of serious lesions and non-ocular effects. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values (with the exception of the sclerae) for each type of lesion.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.44

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

From one hour up to 7 days after administration two animals showed some definitely injected up to crimson colored blood vessels. Slight swelling with partial up to half closed eyelids was observed till 24 hour after application. The third animal showed only one hour up to 24 hours after treatment some hyperaemic up to crimson colored vessels in the conjunctiva as well as obvious swelling with partial eversion of lids one hour after application. Additionally, serous colorless eye discharge was noted one hour after administration in all animals.
14 days after administration all signs of irritation had disappeared.

Other effects:

No clinical signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

According to the findings in this study the substance does not meet the criteria for classification laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

The substance was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405. Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and were fully reversible within 14 days.

According to the findings in this study the substance does not meet the criteria for classification laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).