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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Acceptable study comparable to guideline (no GLP, TS purity not specified, 50 µl TS, 8-day observation period).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
50 µl TS, 8-day observation period
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylmorpholine
EC Number:
203-640-0
EC Name:
4-methylmorpholine
Cas Number:
109-02-4
Molecular formula:
C5H11NO
IUPAC Name:
4-methylmorpholine
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-Methylmorpholin

Test animals / tissue source

Species:
rabbit
Strain:
Angora
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.54 and 2.61 kg

ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of the same rabbits treated with NaCl (0.9%)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.05 ml
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2 (all females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: comparable to the OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

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: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
The mean scores (24/48/72 hours) of the individual animals were:
- cornea score: 1 in 2/2 animals
- iris score: 1 in 2/2 animals
- conjunctivae score: 1 in 2/2 animals
- chemosis score: 0 in 2/2 animals
Other effects:
Mucous bleeding, pupil retraction, ciliary injection and misty opacity were generally present, but also reversible within 5-8 days.

Any other information on results incl. tables

In a skin irritation test, the test substance was corrosive. It might be possible that the results in this eye irritation test were not as severe as expected as only 0.05 ml of the test substance instead of 0.1 ml as recommended in OECD guideline 405 were applied to the eye. Due to the findings of this study, the test substance would have to be classified as eye irritant Cat. 2B according to GHS-criteria. The test substance is however corrosive to the skin (Cat. 1B).

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
In a skin irritation test, the test substance was corrosive.
It might be possible that the results in this eye irritation test were not as severe as expected as only 0.05 ml of the test substance instead of 0.1 ml as recommended in OECD 405 were applied to the eye. Due to the findings of this study, the test substance would have to be classified as eye irritant Cat. 2B according to CLP criteria, although the test substance is corrosive to the skin (Cat. 1B).