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EC number: 229-194-7 | CAS number: 6425-39-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-dimorpholinyldiethyl ether
- EC Number:
- 229-194-7
- EC Name:
- 2,2'-dimorpholinyldiethyl ether
- Cas Number:
- 6425-39-4
- Molecular formula:
- C12H24N2O3
- IUPAC Name:
- 4-{2-[2-(morpholin-4-yl)ethoxy]ethyl}morpholine
- Test material form:
- liquid
- Details on test material:
- - State of aggregation : liquid
- Appearance : colourless to yellow brown
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: H 50541 H x B (Substance number: 95/452)
- Analytical Purity: 98.4%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, exclusion of oxygen (under nitrogen)
OTHER SPECIFICS:
- Name of test substance (as cited in study report): 2,2'-Dimorpholinodiethylether
- Physical state: liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach
- Age at study initiation: yound adult animals
- Weight at study initiation: 3.28 kg and 3.08 kg (males); 3.33 kg (female)
- Housing: single housing in stainless steel mesh cages with grating, floor area: 3000 cm²
- Diet: Kliba-Labordiaet 341, Klingenthalmuehle AG, Kaiseraugust, Switzerland (about 130 g per animal per day)
- Water: about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 days (reading was performed at 1 h, 24 h, 48 h, 72 h and 8 days after application)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes (water)
- Time after start of exposure: 24 h
SCORING SYSTEM: evaluation according to the OECD Guideline Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Other effects:
- Suppuration (48 h) and loss of corneal tissue (48 h and 72 h) were observed in animal#2.
Small retractions in the eyelids (24 h, 48 h and 72 h), pupil contraction (24 h, 48 h and 72 h) and loss of corneal tissue (48 h and 72 h) were observed in animal#3.
Any other information on results incl. tables
Irritant response
Reading |
Animal |
Cornea |
Iris |
Conjunctiva |
Symptoms |
|||
OP |
AR |
RED |
SW |
DI |
||||
1 h |
1 |
0 |
|
0 |
2 |
2 |
2 |
|
2 |
0 |
0 |
0 |
2 |
2 |
2 |
|
|
3 |
0 |
0 |
0 |
2 |
2 |
2 |
|
|
24 h |
1 |
0 |
0 |
0 |
2 |
1 |
1 |
|
2 |
1 |
2 |
1 |
3 |
2 |
2 |
|
|
3 |
1 |
4 |
1 |
3 |
2 |
2 |
SR, PC |
|
48 h |
1 |
0 |
0 |
0 |
2 |
1 |
1 |
|
2 |
1 |
2 |
1 |
3 |
2 |
1 |
S, LC |
|
3 |
1 |
3 |
1 |
3 |
2 |
2 |
SR, PC, LC |
|
72 h |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
|
2 |
1 |
1 |
0 |
2 |
1 |
0 |
LC |
|
3 |
1 |
3 |
2 |
3 |
2 |
1 |
SR, PC, LC |
|
8 d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean |
1 |
0.0 |
|
0.0 |
2.0 |
1.0 |
|
|
2 |
1.0 |
|
0.7 |
2.7 |
1.7 |
|
|
|
3 |
1.0 |
|
1.3 |
3.0 |
2.0 |
|
|
|
Mean |
1, 2, 3 |
0.7 |
|
0.7 |
2.6 |
1.6 |
|
|
OP: opacity; AR: area of cornea involved (1: > 0; 2: >1/4; 3: >1/2; 4: >3/4); RED: redness; SW: swelling; DI: discharge
SR: small retractions in the eyelids; S: suppuration, PC: pupil contracted, LC: loss of corneal tissue
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- The eye irritation potential of the test substance was investigated in White Vienna rabbits according to OECD Guideline 405 and EU Method B.5. The test substance was observed to be irritating to the eyes (category 2B).
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