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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1a Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylenediamine, propoxylated
EC Number:
500-035-6
EC Name:
Ethylenediamine, propoxylated
Cas Number:
25214-63-5
Molecular formula:
(C3H6O)n (C3H60)n (C3H6O)n(C3H6O)n C2H8N2 sum of n: >1 - 8.5
IUPAC Name:
Ethylenediamine, propoxylated
Details on test material:
Name: Ethylenediamine, propoxylated
Molecular weight: 360
Color: brownish
Purity: not reported

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS: Rabbit
- Strain: Himalayan
- Sex: males
- Source: Leuschner & Co., Germany
- Age: approximately 5 months
- Weight at study initiation: 2300 - 2500 g
- Number of animals: 3
- Controls: surrounding untreated skin area served as control

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: undiluted
- Area of exposure: approx. 6 cm2
- Occlusion: semiocclusive
- Vehicle: none
- Total volume applied: 500 µl
- Postexposure period: 7 days
- Removal of test substance: after 4h patches were removed and skin sites evaluated

EXAMINATIONS
- Scoring system: Draize
- Examination time points: 1, 24, 48, and 72 hours after patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1
- Edema: 0

SKIN REACTIONS: All three rabbits exposed for 4 hours to 0.5 ml, ethylenediamine, propoxylated showed an erythema (grade 1) at the examination time-point 60 minutes after patch removal, rabbit no. 1 until 24 hours and rabbit no. 3 until 48 hours after patch removal.

REVERSIBILITY: All test sites appeared normal at 72 hours.
Other effects:
None

Any other information on results incl. tables

AVERAGE SCORE - Erythema: 1 - Edema: 0 SKIN REACTIONS: All three rabbits exposed for 4 hours to 0.5 ml, ethylenediamine, propoxylated showed an erythema (grade 1) at the examination time-point 60 minutes after patch removal, rabbit no. 1 until 24 hours and rabbit no. 3 until 48 hours after patch removal. REVERSIBILITY: All test sites appeared normal at 72 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the present test conditions slight irritation was observed with ethylenediamine, propoxylated. The findings do not warrant classification as skin irritant under GHS.