Registration Dossier
Registration Dossier
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EC number: 946-764-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- -
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: ECC Directives 91/325
- Principles of method if other than guideline:
- The skin test ratings were interpreted according the Council Dir. 83/467/EEC adapting to technical progress for the 50th time the Council Dir. 67/548/EEC.
- GLP compliance:
- no
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt
- EC Number:
- 946-764-7
- Molecular formula:
- -
- IUPAC Name:
- D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 10 cm of area has been designated for the position of the patch. Square gauze pads have been used, secured in place by thin bands of adhesive tape. The entire trunk of the animal has been then wrapped with rubberized cloth.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours and after 5, 7 days
- Number of animals:
- 3 males
- Details on study design:
- Each animal had a non-treated area and a treated area with test material. Each animal served as its own control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: -
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 min, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: -
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 5 and 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: -
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 5 and 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: -
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- The test material EUCAROL AGE ET/UP, in according with EEC Directives 91/325, can be considered non irritant.
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