Registration Dossier
Registration Dossier
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EC number: 614-503-3 | CAS number: 68441-62-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated
- EC Number:
- 614-503-3
- Cas Number:
- 68441-62-3
- Molecular formula:
- (C3H7O2)xC4H4O2Br2(C4H9O2)y with x + y = 2.5
- IUPAC Name:
- 2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated
- Reference substance name:
- Triethyl phosphate
- EC Number:
- 201-114-5
- EC Name:
- Triethyl phosphate
- Cas Number:
- 78-40-0
- Molecular formula:
- C6H15O4P
- IUPAC Name:
- triethyl phosphate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): B251, suspensions in 1% tragacanth mucilage.
- Lot/batch No.: Batch No. 1106
- Physical state: liquid
- Analytical purity: not specified
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TNO, Zeist, The Netherlands
- Age at study initiation: not specified
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-20
- Humidity (%): 65-85
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped free of hair
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3 (male rabbits)
- Details on study design:
- After the acclimatization period the backs of three rabbits were clipped free of hair. From each animal one place was used for the application of the
test material. A quantity of 0.5 g of the test material was introduced under one 6 square em patch of aluminium foil.
After application the animals were immobilized in an animal holder for four hours with the patches secured in place by adhesive tape. Food and water were available ad libitum.
After four hours of exposure the patches were removed, the skin was wiped and the resulting skin reactions were evaluated at 30-60 minutes and 24, 48 and 72 hours after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- No erythema nor edema was observed at any of the readings and therefore the substance is considered not to be irritant to the shaven non-abraded skin of the rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Polyol IXOL B251 is not irritating to skin.
- Executive summary:
The primary skin irritation potential of Polyol IXOL B251 to the rabbit skin was investigated in a study performed according to OECD guideline 404 and under GLP (Duphar B.V., 1985b). 0.5 g of the test substance was applied on the shaven non-abraded skin of three rabbits and occluded under patches for four hours. The patches were removed, and readings of the reactions for erythema and edema were made at 30-60 minutes and at 24, 48 and 72 hours after patchremoval.There was neither erythema nor edema at any of the readings and therefore the test substance is considered not to be irritating to the shaven non-abraded rabbit skin.
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