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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP- and guideline compliant

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ASA
- Substance type: organic
- Physical state: Yellowish clear liquid
- Analytical purity: 97.1%
- Lot/batch No.: 5500001727
- Stability under test conditions: stable
- Storage condition of test material: RT

Test animals / tissue source

Species:
rabbit
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kisslegg
- Age at study initiation: 9 weeks
- Weight at study initiation: 2.1 kg – 2.2 kg
- Housing:Single housing; Terulan cages, Ehret GmbH, A-3430 Tulln, 73 cm x 73 cm bottom area, 50 cm height.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:for at least 5 days before application


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30 – 70%
- Air changes (per hr): 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Approx. 1, 24, 48 and 72 h after application.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: About 24 hours after application of the test item


SCORING SYSTEM: Draize


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Irritant / corrosive response data:
The cornea and the iris were not affected in any animal at any examination term. Slight conjunctival redness (grade 1) was noted in one animal only 1 hour after application, in one animal 1 and 24 hours after application. In the third animal no conjunctival redness was observed.
Slight conjunctival chemosis was noted in all three animals only 1 hour after application. Slight discharge (grade 1) was noted in two animals only 1 h our after application.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the described ocular reactions as well as the average score for irritation, ASA is not irritating to eyes under the test conditions chosen.