reaction mass of sodium acetate, monoethylene glycol and diethylene glycol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium acetate

EC Number:

204-822-2

EC Name:

Potassium acetate

Cas Number:

127-08-2

IUPAC Name:

potassium acetate

Test material form:

other: solution in water

Details on test material:

- Name of test material (as cited in study report): LP 1848, described with CAS number 127-08-2 and potassium acetate solution
- Molecular formula (if other than submission substance): CH3COO-K+
- Physical state: 50.1% solution in water
- Impurities (identity and concentrations): Tolyltriazol 0.1%, Phosphoric acid 0.05%.
- Lot/batch No.: HOE CG 0255 ZD50 0001

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG (internal)
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.4 - 4.1kg
- Diet (ad libitum): Altromin 2123
- Water (ad libitum): deionised.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3C
- Humidity (%): 50 ± 2C
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
- Concentration (if solution): 50% solution in water

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

average of 24, 48 and 72 hour reading

Time point:

other: average of 24, 48 and 72 hour readings

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Time point:

other: average of 24, 48 and 72 hour reading

Score:

0

Max. score:

2

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: average of 24, 48 and 72 hour reading

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: average of 24, 48 and 72 hour reading

Score:

0.9

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Other effects:

Animal #1 had a clear colourless discharge from the treated eye after one hour and a white/yellow viscous discharge was observed at 48 hours but this had cleared by 72 hours. Animals #1 and #3 had a clear colourless discharge from the treated eye after one hour but this had cleared by 24 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not classified as irritating

Executive summary:

In a guideline and GLP eye irritation study, potassium acetate produced signs of slight but transient irritation which manifested as low level conjunctival irritation and chemosis. These effects disappeared by the 72 hour observation timepoint. The effects were not sufficiently severe to warrant classification as an eye irritant.