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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate in study report

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
68 milligrams
Duration of treatment / exposure:
Eye closed with test material in the conjunctival sac of the right eye during 1 second.
Observation period (in vivo):
1 hour, 24 hours, 48 hours , 72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Time point:
other: 1, 24, 48, 72 h
Score:
10
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes at the 24-hour observation and in one treated eye at the 48-hour observation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The organic part of PACTT, 2 Na is not classified as irritant for eyes. As the mineral part of PACTT, 2 Na, Sodium Bromide, is not either classified as irritant for eyes, it can be concluded that the multi-constituent substance has not to be classified as irritant for eyes.

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