Sodium phenoxyacetate hemihydrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A study according to the EU and OECD methods, including GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium phenoxyacetate hemihydrate

EC Number:

222-746-8

EC Name:

Sodium phenoxyacetate hemihydrate

Cas Number:

3598-16-1

Molecular formula:

C8H8O3.Na

IUPAC Name:

sodium phenoxyacetate

Test material form:

solid: particulate/powder

Details on test material:

Common name: sodium phenoxyacetate
CAS No: 3598-16-1
Purity (dry basis): 99.83 %
Appearance: off white powder
Conditions of storage: Room temperature, no light protection
Stability at conditions of storage: Stable
Batch No: 30031722 or WE 30031722
Date of expiry: 13 January 2011
Supplier: Sandoz GmbH

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Germany
- Age at study initiation: ca. 9 weeks.
- Weight at study initiation: 2.2 - 2.8
- Housing: single caging
- Diet: SNIFF K-H ad libitum
- Water: Tap water ad libitum
- Acclimation period: >= 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Equivalent to 0.1 mL: 49 to 50 mg.

Duration of treatment / exposure:

Once.

Observation period (in vivo):

1, 24, 48, 72 h and 7 d p.a.

Number of animals or in vitro replicates:

3.

Details on study design:

Prior to starting the eye irritation/corrosion study the pH-value of the test substance was determined. Substances with a pH < 2.0 and pH > 11.5 need not to be tested for acute eye irritation/corrosion.
Firstly, the test substance was administered to one animal. As no evidence for a serious damage to the eye of this animal was found during the initial 72 hour observation period (no corrosive effect), the test substance was administered to the other two animals subsequently.

The approximate equivalent of 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent a loss of test substance. The weighed amounts of the individual doses were 49, 49 and 50 mg. The left eyes remained untreated and served as a control.
The whole eyes, especially the corneae, the irises and the conjunctivae were examined, using an otoscope lamp.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h, and 7 d

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h, and 7 d

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: A discharge was observed at 1 h p.a. in animal 1.

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Score 4 was observed at 1 h p.a.

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Other effects:

No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.
The untreated eyes ("control eyes") were normal at each observation time.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Cornea and iris were not affected by the test substance. The conjunctiva showed slight redness and chemosis at 24, 48 and 72 h p.a. which was fully reversible at 7 d p.a.

Executive summary:

Eye irritation was investigated according to the EU- and ORCD-methods. The approximate equivalent of 0.1 mL of sodium phenoxyacetate was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. Results:

Corneae and irises: Not affected at any observation point.

Conjunctivae, redness: In all animals some injected blood vessels (score 1) were observed from 1 or 24 h onwards until 72 h p.a.

Conjunctivae, chemosis: Swelling (scores 1, 2 or 4) was seen in all animals 1 h p.a., decreasing in severity with time and lasting until a maximum of 72 h p.a.

Additional findings: Ocular discharge was noted in 1/3 animals only 1 h p.a.