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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Constituent 1
Chemical structure
Reference substance name:
1-butyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile
EC Number:
254-296-3
EC Name:
1-butyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile
Cas Number:
39108-47-9
Molecular formula:
C11H14N2O2
IUPAC Name:
1-butyl-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile
Details on test material:
Name of the test substance used in the study report: N-Butyl-2-hydroxy-3-cyan-4-methylpyridon(6)
solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
A standardized animal laboratory diet was used.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
ca. 50 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 5 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 2 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: d 2
Irritant / corrosive response data:
Control eye (Talkum) showed also redness / conjuctivae score of 1 up to day 7, but not any more at day 8.

Applicant's summary and conclusion

Interpretation of results:
irritating
Conclusions:
Although the treated eyes were not fully recovered at day 8, the findings are expected to be reversible, as the raw data showed an improvement for the corneal opacity from day 0 up to to 8. This is supported by the HET-CAM, which showed no risk of serious damage to the eyes.