Registration Dossier

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study will be available 31/08/2019
Reliability:
1 (reliable without restriction)
Justification for type of information:
The dossier is submitted under DCG issue 10.3 as communicated to ECHA in communication INC000000234289. Incomplete endpoint summary records are indicated in the relevant sections of the dossier. Complete information is not availabole for CSR or Guidance on safe use.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
yes
Remarks:
The volume of test item corresponding to 500 mg was very large, thus it was not possible to add the whole quantity on the membrane surface. The substance used was in excess of the treated area, the deviation has affected the integrity of the study.
GLP compliance:
yes

Test material

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

In vitro test system

Test system:
artificial membrane barrier model
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Negative control: 500 microliters
Positive control: 500microliters
Test item: 500 miligrams
Number of replicates:
Negative control: 1 replicate
Positive control: 1 replicate
Test item: 4 replicates

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
test item
Value:
> 65
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The assay was considered valid if the following criteria were met:
– the positive control should give the expected penetration response time (historical mean value + 3 SD), based on RTC historical control values (12.33±6.75 minutes; n = 16).
– the negative control should not be corrosive within 60 minutes.

Applicant's summary and conclusion