Registration Dossier

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: Guideline study without detailed documentations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24+38+72h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24+48+72h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24+48+72h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24+48+72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24+48+72h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24+48+72h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
other: all animals
Time point:
other: 24+48+72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: all animals
Time point:
other: 24+48+72h
Score:
0
Max. score:
2
Irritant / corrosive response data:
A slight to moderate conjunctival irritation, which cleared in 3 days, was observed. All the individual key scoring levels were low; the mean 24+48+72 h scores for each rabbit are reported in following Table.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008
Conclusions:
DMSO induced a slight to moderate conjunctival irritation which cleared in 3 days  (total reversibility at J4).
Executive summary:

In a test performed by the French Health National Laboratory of the Medicine Agency following OECD Guideline # 405 (LNS, 1992; reliability 2), 0.1 mL of undiluted DMSO was instilled into the eyes of 3 rabbits. A slight to moderate conjunctival irritation, which cleared in 3 days, was observed. All the individual key scoring levels were low.