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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

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
Reference substance name:
Reference substance 001
Cas Number:
153812-94-3
Test material form:
liquid
Details on test material:
Name of the test substance used in the study report: Beta-Formylcrotonsaeuremethylester
Purity: > 95%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Acclimatization period: at least 8 days before study start
One animal per cage (type: stainless steel with wire mesh walk floors; floor area: 40 x 51 cm).
Animal identification via ear tattoo.
They were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
The animals were offered a standardized animal laboratory diet (ca. 130 g/animal/day) as well as tap water (ca. 250 ml/animal/day).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
1
Details on study design:
Single instillation into the conjunctival sac of the right eyelid; the tes substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after test substance instillation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritant / corrosive response data:
Testing was discontinued after 15 days because of severe irritation.
Findings seen 15 days after test substance instillation: loss of hair at margins of eyelids; marginal vascularization of the cornea; pannus; small retrections in the eyelids; suppuration; staphyloma

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria