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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye 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 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(only 0.05 mL applied, no 72 h reading)
Principles of method if other than guideline:
The test substance was applied undiluted to rabbit eyes and the eyes observed for 8 days.
The eyes were not washed out after 24 hours.
GLP compliance:
no

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 / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.82 and 3.02 kg
- no further data


ENVIRONMENTAL CONDITIONS
- no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.05 mL
Duration of treatment / exposure:
- single application (eyes were not washed out after 24 hours)
Observation period (in vivo):
The animals were observed several times on the treatment day and up to 7 or 8 days afterwards, and findings were recorded on working days. Findings were recorded at 10 min, 1, 3, 24 and 48 h and at the end of the observation period.
Number of animals or in vitro replicates:
2 rabbits
Details on study design:
50 µL of the test substance were applied to the conjunctival sac of one eye of 2 animals.
The non- or saline-treated adjacent eye served as a control.

The animals were observed several times on the treatment day and up to 7 or 8 days afterwards,
and findings were recorded on working days.

Removal of the test substance.
The eyes were not washed out after 24 hours as specified in OECD Guideline 405.

Scoring system:
Draize scores

Tool used to assess score:
Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reading after fluorescein application
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: reading after fluorescein application
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

At the 24 h reading, one animal had a conjunctivae score grade 1, the other animal was without findings. At the 48 h reading, both animals were without findings. No chemosis or injury to cornea and iris was observed at any time.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Although only 0.05 mL test substance was applied instead of the 0.1 mL recommened (OECD 405 guideline) the test item can be classified as not irritating to the eye according to EU- and GHS criteria due to the very mild reversible eye reactions noted.
Executive summary:

Although only 0.05 mL of the test substance was applied instead of the 0.1 mL recommened in todays OECD 405 guideline, the test substance can be considered as not irritating to the eye due to the very mild reversible eye reactions noted under the conditions of this study according to Regulation 1272/2008/EC. (BASF, 1967)