Registration Dossier
Registration Dossier
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EC number: 701-461-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 14 October 1999 and 23 October 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
- EC Number:
- 274-263-7
- EC Name:
- Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
- Cas Number:
- 70024-69-0
- Molecular formula:
- Cannot be adequately determined for this UVCB substance
- IUPAC Name:
- branched and linear mono-C20,22,24 and di-C10-C13 alkyl benzenesulfonic acids and petroleum sulphonic acids, calcium salts, overbased
- Details on test material:
- - Storage condition of test material: Ambient
- Other: Clear, dark brown viscous liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2141 to 2331 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): Certified Rabbit Lab diet 150 g/day
- Water (e.g. ad libitum): as libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 30.2 - 48.5%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Eyelids of animals were held closed for one second after installation.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours following dosing and on day 4.
- Number of animals or in vitro replicates:
- 3 male/3 female.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed exposure
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope/ fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 5
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 4
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animals 2 and 3 and 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Animals 4 and 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 1
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 2
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 3
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Animals 4 and 5
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- Animal 6
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Other effects:
- One animal had clear discharge from the eye, one hour post dosing. There were no deaths or changes in bodyweight throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Mean scores at 24, 48 and 72 hours for each animal for corneal opacity and iritis was 0 for all animals. Mean scores for conjuntival redness and oedema were less than 2 in all animals. Therefore, this substance is not irritating to rabbit eyes.
- Executive summary:
In a primary eye irritation study 0.1 ml of substance was instilled into the conjunctival sac of young adultwhite rabbits (3/sex). Animals then were observed for 7 days. Irritation was scored by the method of Draize.
No eye irritation was observed. In this study, substance is not an eye irritant.
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