Registration Dossier
Registration Dossier
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EC number: 938-754-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-11-2011 to 22-11-2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids
- Molecular formula:
- Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
- IUPAC Name:
- Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.16 - 2.67 kg
- Age: 12-20 weeks
- Housing: individual, suspended cages
- Diet: ad libitum, 2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water: ad libitum
- Acclimation period: 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- - Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control: left untreated eye of each test animal
- Amount / concentration applied:
- 0.1 mL of the test material (approximately 99 mg) was placed into the conjunctival sac of the right eye while the left eye served as control.
- Duration of treatment / exposure:
- exposure to test material not limited, not rinsed after application
- Observation period (in vivo):
- assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
no
SCORING SYSTEM:
according to Draize (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
TOOL USED TO ASSESS SCORE:
examination of the eye was facilitated by the use ofthe light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n.a.
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: n.a.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- other: 1 h, 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: n.a.
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2
- Time point:
- other: 24 h, 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: n.a.
- Irritation parameter:
- other: discharge score
- Basis:
- animal: #1, #2
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: discharge score
- Basis:
- animal: #1, #2
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: discharge score
- Basis:
- animal: #1, #2
- Time point:
- other: 48 h, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: n.a.
- Irritant / corrosive response data:
- The test substance produced scattered or diffuse corneal opacity and iridial inflammation in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in both treated eyes one and 24 hours after treatment with minimal conjunctival irritation noted at the 48 hour observation. Both treated eyes appeared normal at the 72 hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008) and DSD (Directive 67/548/EEC)
- Conclusions:
- Based on the results of this study, the test substance was determined to be non-irritant to the eye. According to the criteria of OECD GHS, Regluation (EC) 1272/2008 and of DSD (Directive 67/548/EEC) no classification and labelling is required.
- Executive summary:
In a primary eye irritation study performed according to the testing guideline OECD 405 0.1 mL (99 mg) of Sucroglyceride C12-18, C18unsatd. (92.66% a.i.) was instilled undiluted into the conjunctival sac of one eye of 2 young adult New Zealand White rabbits. Eyes were not washed. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.
Scattered or diffuse corneal opacity and iridial inflammation in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in both treated eyes one and 24 hours after treatment with minimal conjunctival irritation noted at the 48 hour observation. All observed effects were completely reversible within 72 hours and both treated eyes appeared normal at the 72 hour observation.
In this study, Sucroglyceride C12-18, C18unsatd. (93.66% a.i) is not an eye irritant.
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