Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
human

Results and discussion

In vitro

Results
Remarks on result:
other: details is filled in "any onther infomation on results incl. tables"
Remarks:
details is filled in "any onther infomation on results incl. tables"

Any other information on results incl. tables

  optic density (OD) at 570 nm
 replica  1  2  3  4  5  6  7  8  9
 blank  0.047  0.047  0.048  0.049  0.048  0.048      
 negative control  1.628  1.528  1.469  1.487  1.647  1.644  1.656  1.511  1.551
 positive control  0.073  0.067  0.065  0.063  0.097  0.061  0.085  0.066  0.065
 sample  1.29  1.336  1.308  1.272  1.274  1.227  1.274  1.284  1.29

 
   average OD  acceptability  result  SD%  acceptability  result
 negative control  1.569  1.2< OD <2.5  complying  4.780  <18  complying

 
   vitality %  acceptability %  result  SD %  acceptability %  result
 positive conttol  0.071  < 40  complying  16.901  < 18  complying
 
 samply  % viability  acceptability
 1,3-diphenylpropane-1,3-dione  81.32  >50%

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU