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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

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)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(Z)-[(octadec-9-enyloxy)methyl]oxirane
EC Number:
262-268-7
EC Name:
(Z)-[(octadec-9-enyloxy)methyl]oxirane
Cas Number:
60501-41-9
Molecular formula:
C21H40O2
IUPAC Name:
2-[(octadec-9-en-1-yloxy)methyl]oxirane
Details on test material:
- Name of test material (as cited in study report): Cremophor Vorstufe
- Lot/batch No.: 58

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SAVO; MED. versuchstierzuchten GMBH, 7964 Kisslegg/Allgau, FRG
- Weight at study initiation: males 2.02 and 2.05 kg and female 2.02 kg
- Housing: One animal per cage, stainless steel with wire mesh walk floors (floor area: 40 x 51 cm). No bedding in the cages.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, about 130 g per animal per day.
- Water: About 250 mL tap water per animal per day
- Acclimation period: at least 8 days before study start

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL undiluted test substance
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3 (2 males 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm, upper third of the back or flanks, clipped at least 15 hours before the beginning of the study.
- Type of wrap if used: The test patches were secured in position with a porous dressing. Four layers of absorbent gauze + porous bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1).
- Time after start of exposure: at the end of the application period (4 hours)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48, and 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48, and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information