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Registration Dossier
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EC number: 248-778-2 | CAS number: 28016-00-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 Sept 2016 to 4 Oct 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Zinc bis(dinonylnaphthalenesulphonate)
- EC Number:
- 248-778-2
- EC Name:
- Zinc bis(dinonylnaphthalenesulphonate)
- Cas Number:
- 28016-00-4
- Molecular formula:
- Zn[C28H43O3S]2
- IUPAC Name:
- Zinc bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate))
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Appearance: Dark brown liquid
Batch: 983-130
Purity/Composition: 41% solid (UVCB) in oils At room temperature
Test item storage stable under storage conditions until: 26 May 2018 (expiry date)
pH at concentration of 10% in 80% aqueous IPA: 5.8
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Charles River France, L’Arbresle, France
Number of Animals: 3 males
Age and body weight: At start of dosing, the animals were between 12 and 24 weeks old and body weights were at least 1.5 kg.
Identification: Earmark
Health Inspection: At least prior to dosing. It was ensured that the animals were healthy and that the eyes were free from any abnormality.
Test system
- Vehicle:
- other: 41% in mineral oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single treatment into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and 7 and 14 days after instillation.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 1 week later, after considering the degree of eye irritation observed in the first animal. One hour prior to instillation of the test item, buprenorphine (Buprenodale®, Dechra Ltd., Stoke-on-Trent, United Kingdom) 0.01 mg/kg was administered by subcutaneous injection in order to provide a therapeutic level of systemic analgesia.
Five minutes prior to instillation of the test item, two drops of the topical anesthetic alcaine 0.5% (SA Alcon-Couvreur NV, Puurs, Belgium) were applied to both eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Individual Eye Irritation Scores
Animal |
Time after dosing |
Cornea |
Iris |
Conjunctivae |
Comments |
||||
Opacity (0-4) |
Area (0-4) |
Fluor area (%) |
(0-2) |
Redness |
Chemosis |
Discharge |
|||
1861 |
1 hour |
0 |
1 |
|
0 |
2 |
3 |
3 |
g |
24 hours |
0 |
0 |
0 |
0 |
3 |
2 |
3 |
|
|
48 hours |
0 |
0 |
|
0 |
2 |
1 |
2 |
|
|
72 hours |
0 |
0 |
|
0 |
2 |
1 |
1 |
|
|
7 days |
0 |
0 |
|
0 |
1 |
0 |
0 |
|
|
14 days |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
|
191 |
1 hour |
0 |
1 |
|
0 |
2 |
3 |
3 |
g |
24 hours |
0 |
0 |
0 |
0 |
3 |
2 |
2 |
|
|
48 hours |
0 |
0 |
|
0 |
2 |
2 |
2 |
|
|
72 hours |
0 |
0 |
|
0 |
2 |
1 |
1 |
|
|
7 days |
0 |
0 |
|
0 |
1 |
0 |
0 |
|
|
14 days |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
|
192 |
1 hour |
0 |
1 |
|
0 |
2 |
3 |
3 |
g |
24 hours |
0 |
0 |
0 |
0 |
3 |
3 |
2 |
|
|
48 hours |
0 |
0 |
|
0 |
3 |
2 |
2 |
|
|
72 hours |
0 |
0 |
|
0 |
2 |
1 |
1 |
|
|
7 days |
0 |
0 |
|
0 |
1 |
0 |
0 |
|
|
14 days |
0 |
0 |
|
0 |
0 |
0 |
0 |
|
|
1Sentinel.
g = Slight dulling of the normal luster of the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The test item caused serious eye irritation. Effects were fully reversible within 14 days.
- Executive summary:
In an OECD 405 guideline study with Australian White Rabbits, the test substance caused serious eye irritation that was fully reversible within 14 days following installation into one eye of each of three rabbits. Slight dulling of the cornea was noted for all animals on Day 1 only. Treatment of the eyes with 2% fluorscein 24 hours after test item instillation revealed no corneal epithelial damage. No iridial irritation was observed. Given these results, the test substance should be classified as Category 2A (irritation to eyes) based on GHS/CLP criteria.
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