Registration Dossier

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: The study was conducted according to the O.E.C.D. test guideline 404 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl o-tolyl ether
EC Number:
218-645-3
EC Name:
2,3-epoxypropyl o-tolyl ether
Cas Number:
2210-79-9
Molecular formula:
C10H12O2
IUPAC Name:
2-[(2-methylphenoxy)methyl]oxirane
Constituent 2
Reference substance name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
IUPAC Name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The animals were acquired from Kleintierfarm Madoerin AG CR 4414 Fuellinsdorf / Switzerland were 14-15 weeks old and weighed 2.4-2.6 Kg. The animals were maintained Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 0—7830 Emmendingen / FRG). The rabbits were allowed access to Pelleted standard Kliba 341, rabbit maintenance diet (°Kliba, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) and water ad libitum. The animal room was air-conditioned with 10—15 air changes per hour and hourly monitored environment with temperature 20+—3 degrees centigrade, relative humidity 40—70%, 12 hours
artificial fluorescent light/12 hours dark/light period. The animals were acclimated to laboratory conditions for four days before being placed on-study.


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hr
Observation period:
7 days
Number of animals:
3
Details on study design:
Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). On test day 1, 0.5 ml of the test substance was applied to the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed at 1, 24, 48 and 72 hours and at 7 days Intervals. The skin reactions were accessed according to O.E.C.D. Test Guideline no. 404.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: Seven day observation period.
Score:
ca. 1.2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Local signs (mean 1 hour to 7 days) consisted of grade 0.67 erythema and grade 0.27 edema.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The Primary Irritation Index of 1.2 suggests that the test substance is a "mild irritant" of the skin. However, the study data does not support Classification and Labeling as a skin irritant.
Executive summary:

The test substance, 2,3 -epoxypropyl o-tolyl ether was evaluated for skin irritation potential in an O.E.C.D. Test Guideline no 404 study. The Primary Irritation Index of 1.2 observed in the suggests that the test substance is a "mild irritant" of the skin. However, the study data does not support Classification and Labeling as a skin irritant.