Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Sample submitted to INTOX PVT. LTD. , 375, Urawade, Tal. Mulshi, Dist. Pune, Maharashtra, 412115,
Type of information:
experimental study
Adequacy of study:
key study
Study period:
87 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

In vitro test system

Test system:
isolated skin discs
Remarks:
Epidermal surface of skin
Source species:
rat
Cell type:
other:
Cell source:
other: Epidermal surface of skin
Source strain:
Wistar
Vehicle:
not specified
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
150µL of Test item and Control items respectively were applied uniformly to the epidermal surface for 24hours at 22°C.
Duration of treatment / exposure:
Test item and Control items were applied for 24hours at 22°C.
Number of replicates:
3 replicates each for Test item, Positive control and Negative control.

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
not specified
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
transcutaneous electrical resistance (in kΩ)
Value:
10.92
Vehicle controls validity:
not valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
The study "In-vitro Skin Corrosion by Transcutaneous Electrical Resistance Test Method" confirms that Substance is considered as non-corrosive as per the UN GHS for classification of Chemicals.