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Diss Factsheets

Administrative data

Endpoint:
skin 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 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
See certificate in study report

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 grams
Duration of treatment / exposure:
4 hours
Observation period:
1 hour, 24 hours and 48 hours
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0.2
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Very slight erythema was noted at two treated skin one hour after patch removal and at one treated skin at the 24-hour observation. One treated skin appeared normal throughout the study, one other treated skin appeared normal at the 24-hour observation and the remaining treated skin appeared normal at the 48_hour observation. No corrosive effects were noted.

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 skin. As the mineral part of PACTT, 2 Na, Sodium Bromide, is not either classified as irritant for skin, it can be concluded that the multi-constituent substance has not to be classified as irritant for skin.

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