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Toxicological information

Eye irritation

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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:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- State of aggregation : liquid
- Appearance : colourless to yellow brown
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).