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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(5-ethyl-1,3-dioxan-5-yl)methyl acrylate
EC Number:
266-380-7
EC Name:
(5-ethyl-1,3-dioxan-5-yl)methyl acrylate
Cas Number:
66492-51-1
Molecular formula:
C10H16O4
IUPAC Name:
(5-ethyl-1,3-dioxan-5-yl)methyl acrylate
Details on test material:
- Name of test material (as cited in study report): SR 349
- Physical state: Viscous liquid
- Analytical purity: no data
- Lot/batch No.: HYJ1628
- Expiration date of the lot/batch: Jan 1994
- Storage condition of test material: room temperature in the dard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (UK)
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.3 - 3.1kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): SDS Stanrab (P) ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: all rabbits were acclimatised

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light):12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1ml
Duration of treatment / exposure:
substance was not washed out
Observation period (in vivo):
7 days
1h, 1, 2, 3, 4, 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Day 1-7
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Day1-7
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Day 1-7
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Day 1-7
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: #2,3
Time point:
other: 1h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1day
Irritation parameter:
chemosis score
Basis:
animal: #2,3
Time point:
other: 1h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Other effects:
No signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance was not irritating to the eyes of three rabbits.