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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Meets generally accepted scientific standards, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(longer exposure duration, occlusive conditions, no 72 h reading)
Principles of method if other than guideline:
The test substance was applied to the rabbit skin 1, 5 and 15 minutes and for 20 hours using occlusive conditions.
In addition, skin tissue from the ear was tested by wrapping the ear.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-morpholinecarbaldehyde
EC Number:
224-518-3
EC Name:
4-morpholinecarbaldehyde
Cas Number:
4394-85-8
Molecular formula:
C5H9NO2
IUPAC Name:
morpholine-4-carbaldehyde
Details on test material:
- Name of test material (as cited in study report): N-Formylmorpholin
- Physical state: liquid
- Analytical purity: 99.6 %
- pH: neutral
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean ca. 2.95 kg



ENVIRONMENTAL CONDITIONS
- no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
TEST MATERIAL
- the test item was applied undiluted
Duration of treatment / exposure:
20 hours (reading at 1, 5 and 15 minutes and after 20 h)
Observation period:
The animals were observed 7 to 8 days and skin changes were recorded on working days.
Number of animals:
2 rabbits
Details on study design:
Test site
- Area of exposure: 2.5 x 2.5 cm2
- Dressing: occlusive dressing
- Washing: after the application time, the skin was washed with water and Lutrol

Scoring System
- BASF grading for redness and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 5 days
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

Any other information on results incl. tables

At 24 h after patch removal, grade 1 erythema was observed in both animals. At 48 h, grade 1 erythema was observed in the first animals but no erythema in the second animal.

No edema was observed in both animals at any time. All findings were fully reversible within 5 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Based on the results observed it was concluded that N-formylmorpholine shows no irritating or corrosive potential and should not be classified as skin irritating or corrosive according to Regulation 1272/2008/EC. (BASF, 1967)