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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-04-07 to 2010-04-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2008
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): KEMFLUID EQ
- Physical state: yellowish solid paste
- Lot/batch No.: 42
- Expiration date of the lot/batch: 26.07.2010
- Storage condition of test material: room temperature, dry and dark
- Other: pH approx. 3 (5 % in IPA/H2O)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Age at study initiation: not data
- Weight at study initiation: 1929,1631 and 1956 g
- Housing: housing in single steel cages
- Diet (e.g. ad libitum): Altromin 2023 Maintenance diet for rabbits, ad libitum
- Water (e.g. ad libitum): tap water from municipal source, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): dimmed daylight

IN-LIFE DATES: From: To: 2010-04 -07 to 2010-04 -19

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and served as a control.
Amount / concentration applied:
0.1 mL test substance.
As the test substance is a firm solid paste it was melted in a water bath at 60 °C resulting in the formation of a smooth paste. Subsequently it was held at room temperature until it cooled down to 40 °C. Then 0.1 mL of the paste was applied by means of a syringe to the eye of one animal.
Observation period (in vivo):
1 hour and 24, 48, 72 hours and 7 days after application of the test substance.
Number of animals or in vitro replicates:
3 animals, 1 male and 2 females
Details on study design:
SCORING SYSTEM: as outlined in the OECD guideline 405, 2002
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Examinations of ocular reactions were facilitated without any device. After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein to look for damage of the cornea.
One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards
scoring was executed by use of an UV-light lamp. This procedure was repeated at all observation time points until cornea damage was no longer
observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #3
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: #1, #3
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
All 3 animals showed slight to moderate ocular reaction 1 hour after application of the test substance. After 24 hours slight to moderate ocular reactions were still observed in all three animals. Slight cornea opacity was observed in one animal at the 24 hour reading. The cornea damage was no longer observed 48 hours after treatment. Slight irritation of the conjunctivae persists until 72 hours but was fully reversible 7 days after application in all three animals.
Other effects:
No symptoms of systemic toxicity were observed during the whole study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met