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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD), but no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxybutane
EC Number:
221-877-8
EC Name:
2,3-epoxybutane
Cas Number:
3266-23-7
Molecular formula:
C4H8O
IUPAC Name:
2,3-dimethyloxirane
Details on test material:
- Name of test material (as cited in study report): N-Butylenoxid-2,3
- Substance-No.: 81/356

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Weight at study initiation: 3.12 kg (male); mean 2.77 kg (female)
- Housing: individually in stainless stell cages with wiremesh floor (Area: 40 x 51 cm)
- Diet (e.g. ad libitum): OVATOR SOLIKANIN 4 MM; Muskator-Werke (Duesseldorf); ca. 130 g/animal/day
- Water (e.g. ad libitum): VE-water on workdays; tap water on weekends (ca. 250 ml/animal/day); ad libitum
- Acclimation period: ca. 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated other eye from same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
1 male, 2 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: acc. to Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
4
Reversibility:
not fully reversible within: 8 days in 1/3 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects noted
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Animal 1: females, 2.39 kg

Animal 2: male, 3.12 kg

Animal 3: female, 3.14 kg

Results:

Readings Animal Cornea Iris Conjunctival Symptoms
Opacity Area Erythema  Chemosis Discharge
24 h 1 1 4 0 2 2 2  
2 0 0 0 2 2 1  n
3 0 0 0 1 1 1  
48 h 1 1 4 0 2 1 1  
2 0 0 0 1 1 1  
3 0 0 0 1 0 0  
72 h 1 1 4 0 1 0 0  
2 0 0 0 1 0 0  
3 0 0 0 1 0 0  
8 d 1 1 2 0 0 0 0  
2 0 0 0 0 0 0  
3 0 0 0 0 0 0  
mean 24 - 72 h 1 1.0 4.0 0.0 1.7 1.0 1.0  
2 0.0 0.0 0.0 1.3 1.0 0.7  
3 0.0 0.0 0.0 1.0 0.3 0.3  
mean 1 0.3 1.3 0.0 1.3 0.8 0.7  

n: narrowed pupil

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU