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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
Read across from existing in-vivo study on analogue
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April 17-24,2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: test according to the guideline under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Alkylnaphtha1ene Sulfonic Acid
- Physical state: Dark brown viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: young adult
- Weight at study initiation: not indicated
- Housing: individually
- Diet: Pelleted Purina Rabbit Chow #5326 ad libitum
- Water: Filtered tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
applied in the conjucntival sac with the eyelids held together for one second thereafter
Observation period (in vivo):
1, 24, 48 and 72 hours and at 4 and 7 days post-instillation
Number of animals or in vitro replicates:
2 males + 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein at the 24 h observation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 0.45
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: discharge
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 0.9
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
irritant
Other effects:
no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior

Any other information on results incl. tables

Animal no

1

2

3

Day

1

24

48

72

4

7

1

24

48

72

4

7

1

24

48

72

4

7

cornea

0

1

1

1

0

0

0

1

1

1

0

0

0

1

1

1

0

0

iris

0

0

0

0

0

0

0

1

1

0

0

0

0

1

1

0

0

0

conjunctivae

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

redness

2

3

3

2

1

0

2

2

2

2

1

0

2

2

2

1

0

0

chemosis

1

1

1

1

0

0

1

1

1

0

0

0

1

2

1

0

0

0

discharge

2

2

2

2

1

0

2

2

2

1

0

0

2

2

2

1

0

0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is irritating to the eyes
Executive summary:

The test substance was shown to be irritant to the eyes when applied in the eyes of 3 rabbits. The effects were reversible after 7 days. The test substance is considered to be irritant to the eyes according to CLP criteria.