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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
Study period:
no data available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study performed according to OECD Guideline 405 (Acute Eye Irritation / Corrosion).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Morpholine
- Analytical purity: 99 %

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individual in cages
- Diet: controlled access
- Water: ad libitum
- Acclimation period: appr. one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours dark/12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted
Duration of treatment / exposure:
single application,
exposure period: 4 seconds, 30 seconds, 24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 animals per exposure period
Details on study design:
REMOVAL OF TEST SUBSTANCE
If necessary, the treated eye was washed with tap water, at least 24 hous after treatment.

SCORING SYSTEM: according to OECD GL 405

TOOL USED TO ASSESS SCORE: biomicroscope / fluorescein / ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(exposure 4 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 2 - <= 2.3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(exposure 30 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 2 - <= 2.7
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
(exposure 24 h )
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 2.7 - <= 3
Max. score:
3
Irritation parameter:
chemosis score
Remarks:
(exposure 4 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 1 - <= 2.3
Max. score:
4
Irritation parameter:
chemosis score
Remarks:
(exposure 30 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 1 - <= 2.3
Max. score:
4
Irritation parameter:
chemosis score
Remarks:
(exposure 24 h)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 2.7 - <= 3.7
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(exposure 4 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 1.7 - <= 2.3
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(exposure 30 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 1.3 - <= 2
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(exposure 24 h)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 1.3 - <= 1.7
Max. score:
4
Irritation parameter:
iris score
Remarks:
(exposure 4 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 0.5 - <= 0.7
Max. score:
2
Irritation parameter:
iris score
Remarks:
(exposure 30 s)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 0.3 - <= 0.5
Max. score:
2
Irritation parameter:
iris score
Remarks:
(exposure 24 h)
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
>= 0 - <= 0.3
Max. score:
2

Any other information on results incl. tables

All expositions with Morpholine (for 4 s, 30 s, and 24 h) resulted in eye irritation of animals. In addition, rabbits showed necrosis around the eyes. After an exposure time of 24 hours burns (corrosion) were observed. In 2 rabbits corrosion was noted both inside and around the eyes after 30 seconds of exposure. After an observation period of 21 days eye injuries were still observed in one animal.

 

Exposure group 24 hours:

All animals showed necrosis in the eye and loss of fur, sores, redness, and scarring on the front of the upper eyelids outside. In one animal eye injuries were cleared within 10 days and detachment of the outer layers of the cornea were observed.

 

Exposure group 30 s:

In all animals whitish secretions were observed both in and around the eyes.In 2/3 animals eye injuries were cleared within 10 days and detachment of the outer layers of the cornea were observed. In the 2 animals where corrosion was noted, hair loss was also observed.

 

Exposure group 4 s:

In all animals whitish secretions were observed both in and around the eyes. In 2/3 animals eye injuries were cleared within 10 days and detachment of the outer layers of the cornea were observed. One rabbit showed a pale flash film, perhaps with scars.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:
In a primary eye irritation study (Koch et al., 1985), 100 µL of undiluted Morpholine (99 %) was instilled into the conjunctival sac of the left eye of 3 rabbits. The eyes were washed out after 24 hours. Further exposure times were 4 and 30 seconds, respectively (3 rabbits/exposure time). Animals were observed for 21 days. Irritation was scored according to OECD guideline 405. All three expositions gave rise to eye irritation. All animals showed necrosis in and around the eyes. After an exposure time of 24 hours burns (corrosion) were observed. Two of the animals also gave rise to corrosion both inside and around the eyes at 30 seconds of exposure. After the observation period eye injuries were still observed in one animal. The authors classified Morpholine as irritant substance; however, corrosive effects in several animals were observed. Thus, Morpholine can be regarded as a corrosive substance. This study is classified acceptable. It satisfies the requirement of OECD test guideline 405.