Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
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:
- 2 001
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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