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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: well-documented, guideline-conform study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)
EC Number:
257-765-0
EC Name:
2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)
Cas Number:
52234-82-9
Molecular formula:
C21H35N3O6
IUPAC Name:
6-(aziridin-1-yl)-2-({[3-(aziridin-1-yl)propanoyl]oxy}methyl)-2-ethyl-4-oxohexyl 3-(aziridin-1-yl)propanoate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: WF 4746

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
Acclimatization period: at least 8 days before study start
Mean body weight: male 3.18 kg, females 2.92 kg
Singly housing in stainless steel wire mesh cages (floor area 40 x 51 cm).
The animals were identified 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 (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the animals
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 min after removal of the test patches and 24 h, 48 h, 72 h after the beginning of the application
Number of animals:
3
Details on study design:
Clipping of the fur at least 15 hours before study start.
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Removal of the test substance at the end of the application period with Lutrol and Lutrol/water (1:1).
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after beginning of application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met