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EC number: 939-512-2 | CAS number: 85681-55-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-09-11 to 1997-10-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
- EC Number:
- 939-512-2
- Cas Number:
- 85681-55-6
- Molecular formula:
- Not applicable for UVCB
- IUPAC Name:
- Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
- Details on test material:
- - Name of test material (as cited in study report): LATHANOL LAL
- Purity 100% (UVCB)
- Lot/batch No.: Lot #7-20041
- Substance type: white powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 2010 - 2300 g
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))
IN-LIFE DATES: From: 1997-09-11 To: 1997-10-02
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye acts as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (packed volume) - Duration of treatment / exposure:
- Eyes not washed.
21 days - Observation period (in vivo):
- 1, 24, 48, 72, 168, 336 and 504 hours
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein and UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14d
- Irritant / corrosive response data:
- See Table 1
There were positive eye irritation reactions in all of the six test subjects and the maximum group mean score was 37.0/110.0 at the 24 hour observation. Irreversible effects were observed in at least 1 of the six test animals at the end of the 21 d observation period. - Other effects:
- No other effects noted
Any other information on results incl. tables
Table 1: Individual irritation scores
Rabbit #1
|
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Av. 24/48 /72 h |
Fully reversible: |
Cornea |
- |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
No |
Iris |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
Yes |
Conjunctiva |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
2 |
No |
Chemosis |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
2 |
Yes |
Rabbit #2
|
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Av. 24/48 /72 h |
Fully reversible: |
Cornea |
- |
1 |
1 |
1 |
1 |
2 |
3 |
1 |
No |
Iris |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
No |
Conjunctiva |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
No |
Chemosis |
3 |
2 |
2 |
2 |
2 |
2 |
1 |
2 |
No |
Rabbit #3
|
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Av. 24/48 /72 h |
Fully reversible: |
Cornea |
- |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
Yes |
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0.7 |
Yes |
Conjunctiva |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
2 |
Yes |
Chemosis |
2 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
Yes |
Rabbit #4
|
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Av. 24/48 /72 h |
Fully reversible: |
Cornea |
- |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
Yes |
Iris |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0.3 |
Yes |
Conjunctiva |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
2 |
No |
Chemosis |
3 |
2 |
2 |
2 |
2 |
0 |
0 |
2 |
Yes |
Rabbit #5
|
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Av. 24/48 /72 h |
Fully reversible: |
Cornea |
- |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
Yes |
Iris |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0.3 |
Yes |
Conjunctiva |
2 |
2 |
2 |
1 |
1 |
1 |
0 |
1.7 |
Yes |
Chemosis |
3 |
2 |
2 |
1 |
1 |
0 |
0 |
1.7 |
Yes |
Rabbit #6
|
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Av. 24/48 /72 h |
Fully reversible: |
Cornea |
- |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
Yes |
Iris |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0.3 |
Yes |
Conjunctiva |
2 |
2 |
2 |
1 |
1 |
0 |
0 |
1.7 |
Yes |
Chemosis |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
1.3 |
Yes |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were positive eye irritation reactions in all of the six test subjects and the maximum group mean score was 37.0/110.0 at the 24 hour observation. Effects observed were not fully reversible in at least one animal by the 504 hour (21 day) observation point.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is required for eye irritation. As effects are not reversible in at least one animal, classification as Category 1 serious eye damage is applicable. - Executive summary:
In an OECD Guideline No. 405 0.1 mL of the test material was applied as supplied to the non-irrigated eye of six albino New Zealand rabbits. Irritation was recorded using the Draize scale at 1, 24, 48, 72, 168, 336 and 504 hour time points.
There were positive eye irritation reactions in all of the six test subjects and the maximum group mean score was 37.0/110.0 at the 24 hour observation. Effects observed were not fully reversible in at least one animal by the 504 hour (21 day) observation point.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is required for eye irritation. As effects are not reversible in at least one animal, classification as Category 1 serious eye damage is applicable.
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