Registration Dossier

Diss Factsheets

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:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Principles of method if other than guideline:
This in vitro study was performed in order to evaluate the potential of Lubricating oils, used, distd. / Distillato leggero to evoke skin irritation in a reconstructed human epidermis (RhE) test method.
Skin irritation refers to the production of reversible damage to the skin following the appli-cation of a test chemical.
The test consists of a topical exposure of the neat test item to a human reconstructed epi-dermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide, present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated nega-tive controls is used to predict the skin irritation potential.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Lubricating oils, used, distd.
EC Number:
295-421-1
EC Name:
Lubricating oils, used, distd.
Cas Number:
92045-40-4
IUPAC Name:
Lubricating oils, used, distd.
Test material form:
other: liquid
Details on test material:
Representative sample of the substance.

Test system

Controls:
yes
Duration of treatment / exposure:
60 minutes

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: Optical density
Value:
1.4
Vehicle controls validity:
valid
Negative controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item Lubricating oils, used, distd. / Distillato leggero is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) test method.
According to CLP regulation, the substance should not be classified as skin irritant.