Registration Dossier
Registration Dossier
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EC number: 262-110-7 | CAS number: 60223-95-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- Existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study with limited information on method and results. The study is used in a worst case approach. The information in the report is limited to the information in the summary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA J CFR, Tit 1e 21, para. 191. 12
- GLP compliance:
- no
Test material
- Reference substance name:
- Dinonylnaphthalenedisulphonic acid
- EC Number:
- 262-110-7
- EC Name:
- Dinonylnaphthalenedisulphonic acid
- Cas Number:
- 60223-95-2
- Molecular formula:
- C28 H44 O6 S2
- IUPAC Name:
- dinonylnaphthalenedisulphonic acid
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Nacure 155
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS: no data
ENVIRONMENTAL CONDITIONS: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 55% - Observation period (in vivo):
- scored at 24, 48, 72 hours and 4, 7 and 14 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: scoring to scale system (similar to Draize)
cornea: (severity + area) * 5
iris * 5
conjunctivae: (redness + chemosis+ discharge) *2
TOOL USED TO ASSESS SCORE: not indicated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 14 d
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 14 d
- Score:
- 1.5
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- irritant
- Other effects:
- none reported
Any other information on results incl. tables
Animal no |
1 |
2 |
3 |
|
|
|
|
|
||||||||||
24 |
48 |
72 |
4 |
7 |
14 |
24 |
48 |
72 |
4 |
7 |
14 |
24 |
48 |
72 |
4 |
7 |
14 |
|
cornea |
3 |
3 |
3 |
1 |
0 |
0 |
3 |
3 |
0 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
0 |
iris |
2 |
1 |
1 |
1 |
0 |
0 |
2 |
0 |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
1 |
1 |
conjunctivae |
effects at all time points in all animals |
|||||||||||||||||
Animal no |
4 |
|
|
|
|
|
5 |
|
|
|
|
|
6 |
|
|
|
|
|
|
24 |
48 |
72 |
4 |
7 |
14 |
24 |
48 |
72 |
4 |
7 |
14 |
24 |
48 |
72 |
4 |
7 |
14 |
cornea |
3 |
3 |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
2 |
1.5 |
3 |
1 |
1 |
1 |
1 |
1 |
iris |
2 |
2 |
2 |
1 |
0 |
0 |
2 |
2 |
2 |
2 |
1 |
1 |
2 |
0 |
1 |
1 |
0 |
0 |
conjunctivae |
effects at all time points in all animals |
|||||||||||||||||
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:
- The substance is a severe eye irritant
- Executive summary:
The test substance was applied to the eye of 6 rabbits. Severe effects on cornea and iris were observed during the 14 day observation period. The effects including those on the conjunctivae were not fully reversible. The substance is considered to be a severe eye irritant and has to be classified as H318.
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