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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
Study period:
1986-04-08 to 1986-04-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, non GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
EC Number:
289-214-5
EC Name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
Cas Number:
86261-90-7
Molecular formula:
C9H14N2O3
IUPAC Name:
2-(2-oxoimidazolidin-1-yl)ethyl methacrylate
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 2.76 kg; females 2.86 kg
- Housing: single in stainless steel cages
- Diet: Kliba 341, 4mm, Fa. Klingentalmuehle AG, Kaiseraugst, CH, ca. 130 g/d
- Water: tap water, ca. 250 mL/d
- Acclimation period: at least 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
water
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 80% (w/w)
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm; upper third of the back or flanks
- Type of wrap if used: four layers of absorbent gauze plus porous bandage


REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1)


SCORING SYSTEM: OECD Draize scoring system
30 -60 min after patch removal the first reading was performed; the relevant readings for classification were performed after 24, 48 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
No irritant effects seen in any reading.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU