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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
Irritation parameter:
iris score
Time point:
other: average of 24, 48 and 72 hour reading
Score:
0
Max. score:
2
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
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.