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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:
1988-07-12 to 1988-08-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study without deviations
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- colourless liquid
- purity: ca. 99%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Toxicoloy, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.3 - 3.4 kg
- Housing: single in cages, acclimatised room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3°C
- Humidity (%): 50 +-20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL undiluted
unrinsed
Duration of treatment / exposure:
24 h, afterwards washing with saline and fluorescein staining
Observation period (in vivo):
1, 24, 48 and 72 h
if necessary 7 days
Number of animals or in vitro replicates:
3
Details on study design:
No additional information

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24+48+72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24+48+72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24+48+78 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24+48+72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24+48+72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24+48+72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24+48+72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24+48+72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24+48+72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24+48+72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24+48+72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24+48+72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Other effects:
No additional information

Any other information on results incl. tables

 Results of eye irritation study (24-h exposure): Mean effects scores over all animals and time

 

Cornea

Iris

Conjunctiva

Redness

Chemosis

Score (average of animals investigated)

0 to 4

0 to 2

0 to 3

0 to 4

1 h

0.00

0.33

2.00

2.67

24 h

0.67

0.67

2.67

2.00

48 h

1.00

0.00

2.00

1.00

72 h

1.00

0.00

1.67

0.33

Average 24 h, 48 h, 72 h

0.89

0.22

2.11

1.11

Reversibility*

c

-

c

c

Average time for reversion

7 d

-

7 d

7 d

*   c:  completely reversible
            

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:

Based on CLP, butyraldehyde has to be allocated to category 2 (irritating to eyes).
Executive summary:

In a valid standard guideline study using 3 rabbits according to OECD 405 and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion), instillation of a single dose of undiluted butyraldehyde (0.1 ml) produced slight to moderate irritation which completely reversed within 48 h to 7 d: One through 72 hours p.a., conjunctivae were distinctly hyperaemic (score 3 and 2), associated with slight to moderate swelling (score 3, 2, 1). In 2/3 animals, the iris was transiently reddened (score 1 and 0), and the cornea transiently diffusely turbid (scores 1 and 0). Additionally, initially a clear, later a white slimy discharge and bleeding of the conjunctivae and nictitating membranes was observed. All effects completely subsided within 7 d.