Potassium sulfate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 April 2010 - 10 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles.

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:

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

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium sulphate

IUPAC Name:

Potassium sulphate

Details on test material:

- Name of test material (as cited in study report):Potassium sulfate
- Substance type:White powder (determined at NOTOX)
- Physical state: Solid
- Stability under test conditions:Stable
- Storage condition of test material:At room temperature in the dark
- Solubility in vehicle (Water): 12g/ 100mL at 25°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:Harlan, Belton, Leics, England
- Age at study initiation:at least 6 weeks old
- Weight at study initiation:at least 1.0 kg.
- Housing:Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum):Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum):Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18.6 – 19.4ºC
- Humidity (%):43 – 73%
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.

IN-LIFE DATES: From: 12 April 2010 To:10 May 2010

Health inspection
A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye of each rabbit remained untreated and served as the reverence control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):average, 99.0 mg (range 98.7 - 99.5 mg) of the test substance (a volume of approximately 0.1 mL)

Duration of treatment / exposure:

The eyes of the test animals have not been washed

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 hrs

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours in one animal and within 14 days in the other two animals.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours in two animals and 48 hours in the other animal

Results 5

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours in one animal and 48 hours in the other two animals

Irritant / corrosive response data:

Instillation of approximately 99 mg of Potassium sulfate (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae.
The corneal injury consisted of opacity (slightly dulling of the luster only) in two animals. The slight dulling resolved within 24 hours in both animals.
Iridial irritation grade 1 was observed in all three animals and resolved within 24 hours.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 48 hours in one animal and within 14 days in the other two animals.

Treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on these results Potassium sulfate does not have to be classified and has no obligatory labelling requirement for eye irritation according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),
- Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures,
- EC criteria for classification and labelling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Union).