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EC number: - | CAS number: 2156594-77-1
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 02 Nov 2016 to 05 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- October 02, 2012
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 30 May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147
- Version / remarks:
- November 24, 2000
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tetrasodium 2-sulfonatododecanoate 2-sulfonatotetradecanoate
- Cas Number:
- 2156594-77-1
- Molecular formula:
- Unspecified
- IUPAC Name:
- tetrasodium 2-sulfonatododecanoate 2-sulfonatotetradecanoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Ra-He 2014-054
- Test item No.: 15/0531-1
- Purity test date: 100% UVCB
- Homogeity: The test substance was homogeneous by visual inspection.
- Appearance: Solid / beige
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW – (SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Sex: female
- Age at study initiation: Approx. 4 months
- Weight at study initiation: 2.96 – 3.54 kg
- Housing: Animals were individually housed in stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2.
- Enrichment: Wooden gnawing blocks (Type KNH E-041); Abedd ® Lab. and Vet. Service GmbH Vienna, Austria
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approx. 10
- Photoperiod: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL bulk volume (about 28 mg of the comminuted test item).
- Duration of treatment / exposure:
- The test item was applied in a single dose to the conjunctival sac of the right eyelid.
- Observation period (in vivo):
- Approx. 1, 24, 48 and 72 h after application and then at weekly intervals maximally up to day 14.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye of the animal(s) was rinsed with 3 to 6 mL of lukewarm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start exposure period: about (but not less than) 1 hour after application of the test item
PROCEDURE
- Body weight determination: Just before application of the test item and after the last reading.
- Local anesthesia: One drop of local anesthetic eye drops in each eye.
- Analgesia: 1 hour before and 8 hours after application with buprenorphine (0.01 mg/kg s.c.) and thereafter in 12 hour intervals until local and/or systemic findings had nearly disappeared. Meloxicam (0.5 mg/kg s.c.) 8 hours after application and thereafter in 24 hours intervals until local and/or systemic findings had nearly disappeared.
- Mortality: A check for any dead or moribund animals was made at least once each day.
SCORING SYSTEM:
The evaluation of eye irritation was performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.
TOOL USED TO ASSESS SCORE:
Reading reactions on cornea or iris were observed using a slit lamp. Additional findings like corneal lesions detected with the aid of fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- 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:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Additional findings like corneal lesions detected with the aid of fluorescein (grade 1 – 2) and injected scleral vessels in a circumscribed or circular area were noted in the animals within 7 days after application.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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