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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
Study period:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Meets generall accepted scientific standards, well documented and acceptable for assessment. Study similar to OECD guideline 404.

Data source

Reference
Reference Type:
publication
Title:
Skin Irritation
Author:
Japanese government
Year:
2005
Bibliographic source:
OECD SIDS Initial Assessment Report for SIAM21 and OECD Agreed Conclusions

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:
4-ethylmorpholine
EC Number:
202-885-0
EC Name:
4-ethylmorpholine
Cas Number:
100-74-3
Molecular formula:
C6H13NO
IUPAC Name:
4-ethylmorpholine
Test material form:
liquid
Details on test material:
- Alternative names of reference substance: Jeffcat NEM; N-ethylmorpholine; 4-ethylmorpholin; Morpholine, 4-ethyl-
- Molecular formula: C6H13NO
- Molecular weight: 115.17
- SMILES notation: CCN1CCOCC1
- InChl: InChI=1/C6H13NO/c1-2-7-3-5-8-6-4-7/h2-6H2,1H3

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
contact periods were 1, 5, and 15 minutes and 20 hours
Observation period:
24hrs and 8 days post treatment
Details on study design:
TEST SITE
- Area of exposure: dorsal region
- % coverage: no data
- Type of wrap if used: occlusive, no further data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: table of Draize contained in the OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: after 1 min exposure
Time point:
other: 24 hrs
Score:
2
Irritation parameter:
erythema score
Basis:
other: after 5 min exposure
Time point:
other: 24 hrs
Score:
3
Irritation parameter:
erythema score
Basis:
other: after 15 min exposure
Time point:
other: 24 hrs
Score:
3
Remarks on result:
other: N2
Irritation parameter:
erythema score
Basis:
other: after 20 hrs exposure
Time point:
other: 24 hrs
Score:
3
Remarks on result:
other: N2
Irritation parameter:
edema score
Basis:
other: after 1 min exposure
Time point:
other: 24 hrs
Score:
0
Irritation parameter:
edema score
Basis:
other: after 5 min exposure
Time point:
other: 24 hrs
Score:
2
Irritation parameter:
edema score
Basis:
other: after 15 min exposure
Time point:
other: 24 hrs
Score:
0
Irritation parameter:
edema score
Basis:
other: after 20 hrs exposure
Time point:
other: 24 hrs
Score:
2
Irritation parameter:
erythema score
Basis:
other: after 1 min exposure
Time point:
other: 8 days
Score:
3
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
other: after 5 min exposure
Time point:
other: 8 days
Remarks on result:
other: N 2
Irritation parameter:
erythema score
Basis:
other: after 15 min exposure
Time point:
other: 8 days
Remarks on result:
other: N 3
Irritation parameter:
erythema score
Basis:
other: after 20 hrs exposure
Time point:
other: 8 days
Remarks on result:
other: N 3
Irritant / corrosive response data:
Moderate to severe skin irritation was noted at 24 hours post treatment even after short contact periods of 1 or 15 minutes. The lesions aggravated and developed into full thickness necrosis within 8 days post treatment

Any other information on results incl. tables

Skin reaction scores similar to the table contained in OECD guideline 404 after 24 hours or 8 days:

                       24 hrs             8 days
-----------------------------------------------------------
Erythema
1 minute         2                     Desquamation 3
5 minutes        3                     N 2
15 minutes      3 / N 2            N 3
20 hours         3 / N 2            N 3
-----------------------------------------------------------
Edema
1 minute         0
5 minutes        2
15 minutes      0
20 hours         2
-----------------------------------------------------------
N = necrosis

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The test substance was considered corrosive category 1 to skin.