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Registration Dossier
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EC number: 701-363-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- adopted September 19, 1984
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine
- EC Number:
- 701-363-4
- Molecular formula:
- Not specified UVCB - Reaction product of ethoxylated (0-7 EO) propylidenetrimethanol with acrylic acid and dibutylamine (propylidenetrimethanol with acrylic acid : dibutylamine = 5:1)
- IUPAC Name:
- propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine
- Details on test material:
- - Name of test material (as cited in study report): Laromer LR8869
- Physical state: yellowish liquid
- Analytical purity: 99.8
- Purity test date: 02/1992
- Lot/batch No.: 1/92
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator; exclusion of light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach, FRG
- Age at study initiation: young adult
- Weight at study initiation: 3.18 - 3.59kg
- Housing: single in stainless steel cages with wire mesh floors (40x51cm)
- Diet (e.g. ad libitum): Kliba lab.diet 341 ad lib. (app. 130g / animal / day)
- Water (e.g. ad libitum): 250ml tap water / day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml / rabbit - Duration of treatment / exposure:
- 4h
- Observation period:
- 8 days
observations: 1h after removal of dressing, 1, 2, 3, 8 days after application - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 X 2x5 cm
- Type of wrap if used: test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, D-W6750 Kaiserslautern) and Fixomull@ Stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period, using Lutrol and Lutrol/water (1 : 1)
- Time after start of exposure:4h
SCORING SYSTEM: Draize, as described in OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean day 1-3
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scaling observed on day 8
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean day 1-3
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: scaling observed on day 8
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean day 1-3
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: scaling observed on day 8
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: day 1-8
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the skin.
- Executive summary:
The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml to the intact skin of 3 White Vienna rabbits for 4 hours under semiocclusive dressing. The average score (24 to 72 hours) for irritation was calculated to be 0.9 for erythema and 0.0 for edema. The skin reactions were reversible within 8 days, thus the study was terminated.
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