Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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:
Study, similar to OECD guideline 405, meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): undiluted

The undiluted test substance was administered into the conjunctival sac of the rabbit's eye.
Duration of treatment / exposure:
no data
Observation period (in vivo):
at 1 and 24 hrs, and 8d post treatment
Number of animals or in vitro replicates:
no data
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: corneal and conjunctival reactions were scored similar to the table contained in OECD guideline 405.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Time point:
other: 1h / 24h / 8days
Score:
ca. 3
Irritation parameter:
conjunctivae score
Time point:
other: 1h / 24h / 8days
Score:
>= 1 - ca. 3
Irritant / corrosive response data:
severe and persistent eye lesions were noted though the dose volume was only 50% of that required by the current OECD guideline 405

Any other information on results incl. tables

Eye reactions, scored similar to the table contained in OECD guideline 405 were as follows:

                       1 h      24 hrs 8 days
-----------------------------------------------------------
Conjunctiva
Erythema        3         3
Edema            3         3
                           bleeding    bleeding

Cornea
Opacity          3         3         1
-----------------------------------------------------------

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Corrosivity to the eyes must be taken into consideration