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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting 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other: Guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO; MED. versuchstierzuchten GMBH, 7964 Kisslegg/Allgau, FRG
- Weight at study initiation: males 2.44 and 2.56 kg and female 2.62 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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL undiluted
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Application: Single instillation into the conjunctival sac of the right eyelid
- The test substance was not washed out.
- Readings: 1 h, 24 h, 48 h and 72 h after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Clearly increased discharge was observed in all animals 1 hour after instillation of the test substance. Slight conjunctivae redness was observed in two animals and was fully reversible within 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information