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
Study period:
1970s-1980s
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: olive oil
Duration of treatment / exposure:
72h
Observation period (in vivo):
1, 6, 10, 24, 48 and 72h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other:
Conclusions:
CLP criteria not met
Executive summary:

The introduction into eyes of 0.2 ml of a 3% AGS solution in olive oil, without washing, caused in 2 of the 6 rabbits the injection of few conjunctival vessels. Recovery was complete within 48 h. The results showed no irritant activity on the rabbits' eye. The results obtained indicate that, at concentration tested, AGS is practically devoid of any significant irritant activity. In fact, according to the method, a material is considered irritant if 4 or more animals, in a test group of 6 rabbits, exhibit a positive reaction in any tissue.