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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:
other: 24, 48, 72 average
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr average
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr average
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr average
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr average
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.