Registration Dossier
Registration Dossier
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EC number: 500-066-5 | CAS number: 28961-43-5 1 - 6.5 moles ethoxylated
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 Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- ethoxylated trimethylolpropane triacrylate (TMPeoTA)
- IUPAC Name:
- ethoxylated trimethylolpropane triacrylate (TMPeoTA)
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-066-5
- EC Name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- Cas Number:
- 28961-43-5
- Molecular formula:
- n.a.
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-[(1-oxo-2- propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
- Details on test material:
- - Physical state: liquid
- Analytical purity: > 83 %
- Lot/batch No.: B40071
- Stability under test conditions: The stability of the test substance was confirmed by reanalysis
- Storage condition of test material: room temperature, exclusion of light
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: Centre Lago S.A., France
- Age at study initiation: 8-9 months
- Weight at study initiation: 3.95-4.00 kg
- Housing: individually
- Diet: 130g/animal/day (Kliba-Labordiät)
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours as all animals were free of signs of irritation
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: test patch and Fixomull stretch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: animals were free of signs of edema at all times
Any other information on results incl. tables
The mean individual scores (24/48/72 hours) of the animals were:
erythema: 0 in 2/3 animals, 1 in 1/3 animals
edema: 0 in 3/3 animals
The test substance is not irritating to the skin according to EU- and GHS-criteria as only marginal signs of irritation were observed in one animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not irritating
- Conclusions:
- TMPeoTA does not give indication of an irritant property to the skin under the test conditions chosen
- Executive summary:
The potential of "confidential substance name" to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing.
After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after removal of the patch.
Slight or moderate erythema was observed in all animals during the course of the study. The cutaneous reactions were reversible in all animals within 72 hours after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.3 for erythema and 0.0 for edema.
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