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Toxicological information

Skin irritation / corrosion

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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:
2002
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

Constituent 1
Reference substance name:
ethoxylated trimethylolpropane triacrylate (TMPeoTA)
IUPAC Name:
ethoxylated trimethylolpropane triacrylate (TMPeoTA)
Constituent 2
Chemical structure
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:
2,2-bis({[2-(prop-2-enoyloxy)ethoxy]methyl})butyl prop-2-enoate; 2-({2-[2-(prop-2-enoyloxy)ethoxy]ethoxy}methyl)-2-{[2-(prop-2-enoyloxy)ethoxy]methyl}butyl prop-2-enoate; 2-{2-[2,2-bis({[2-(prop-2-enoyloxy)ethoxy]methyl})butoxy]ethoxy}ethyl prop-2-enoate
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

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.