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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(only 50 µL of the test substance were used and the observation period was 8 days)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylethanolamine
- Analytical purity: >99%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.19 and 3.17 kg
- Diet: Sniff (no further details were given)
No further data.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
1.5
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
0
Max. score:
0
Reversibility:
other: not affected
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

Findings: animal 1 / animal 2

 Time

corneal opacity

 erythema

chemosis

iritis

 1 h

2/3

0/2

2/1

0/0

 24 h

2/3

2/2

2/2

0/0

 48 h

2/3

2/2

1/2

2/0

 72 h

-/-

-/-

-/-

-/-

 8 d

3/3

2/2

2/2

2/0

 mean

2/3

2/2

1.5/2

1/0

Mean values over 24 and 48 h. Effects were not evaluated after 72 h

The substance led to bloody secretion 1 h after application in both animals. Detachment of the cornea was observed in one animal 48 h after application. At the end of the observation period after 8 days necrosis of the eyelids, loss of hair around the eye, corrosion and purulence was observed.

Applicant's summary and conclusion

Interpretation of results:
Category I
Remarks:
Migrated information irreversible effects on the eye Criteria used for interpretation of results: EU
Conclusions:
Butylethanolamine produced serious damage to rabbits' eyes.
Executive summary:

In a primary eye irritation study (BASF 1977) 0.05 mL of the unchanged test substance was instilled into the conjunctival sac of two Vienna White rabbits (without washing). Animals then were observed for 8 days. The original grading was converted into the numerical grading according to Draize. The test substance led to bloody secretion 1 h after application in both animals. Detachment of the cornea was observed in one animal 48 h after application. The mean (24 – 48 h) cornea, conjunctivae, chemosis and iris score was 2, 2, 1.5, 1 for animal 1 and 3, 2, 2, 0 for animal 2, respectively. All effects were not reversible within 8 days. Additionally, necrosis of the eyelids, loss of hair around the eye, corrosion and purulence was observed at the end of the observation period after 8 days.