Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 (OECD), but no GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach, Germany
- Weight at study initiation: 3.04 kg (male), mean 2.86 kg (females)
- Housing: individually in stainless steel 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): daily 250 ml VE-water on working days; tap water on weekends
- Acclimation period: ca. 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: upper third of back or flanks of animals
- Type of wrap if used: 2.5 x 2.5 cm lint was applied to site and covered by tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol and lutrol:water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM:
Acc. to Draize-system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted

Any other information on results incl. tables

Animal 1: female, 3.13 kg

Animal 2: female, 2.58 kg

Animal 3: male, 3.04 kg

Results:

Readings Animal Erythema Edema Additional findings
24 h 1 0 0  
2 0 0  
3 0 0  
48 h 1 0 0  
2 0 0  
3 0 0  
72 h 1 0 0  
2 0 0  
3 0 0  
8 d 1 0 0  
2 0 0  
3 0 0  
mean 24 - 72 h 1 0.0 0.0  
2 0.0 0.0  
3 0.0 0.0  
mean 24 - 72 h   0.0 0.0  

Applicant's summary and conclusion

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