Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (GLP)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 402, EC B.3, OPPTS 870.1200
Deviations:
no
Remarks:
24 hours exposure
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technical product

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
2000 mg/kg bw
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
5m, 5fm

Results and discussion

In vivo

Results
Irritation parameter:
other: scar formation
Basis:
animal #3
Time point:
other: day 9 post exposure
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
other: female rats

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
2000 mg/kg bw of Aflammit SAP is corrosive to skin after 24 hours exposure. Scar formation becomes visible at day 9 post application.