Registration Dossier
Registration Dossier
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EC number: 940-678-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 3 - 10, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The eye irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows that the substance is an eye irritant. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts) was old name for EUCAROL AGE SS/ND before REACH regulatory - new nomenclature. The substance was identified with: CAS: 151911-53-4 EC: 500-331-5
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC directive 91/325
- Principles of method if other than guideline:
- Results were interpreted according to the Council Dir. 83/467/EEC adapting for the 50th time Council Dir. 67/548/EEC .
- GLP compliance:
- no
Test material
- Reference substance name:
- D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts
- EC Number:
- 500-331-5
- EC Name:
- D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts
- Cas Number:
- 151911-53-4
- IUPAC Name:
- 151911-53-4
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Breeding "Conelli" - Arona, Italy
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages of mm 450 x 500 x 380 with automatic washing cycle
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered water from local network
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml/animal
- Observation period (in vivo):
- 1-24-48 and 72 hours and 7 days from instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- Each animal had an eye treated and the other eye which remained untreated, as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, when administered by ocular route to rabbits, in single administration, in according with EEC Dir. 91/325, is to be considered irritant for the eye.
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