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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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.