Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the available information indicates that the substance should be classified for respiratory sensitisation or corrosivity
Cross-reference
Reason / purpose:
reference to other study
Reference
Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
no
GLP compliance:
yes
Test system:
human skin model
Source species:
other: reconstructed epidermis (details see test report)
Cell type:
other: see test report
Cell source:
other: see test report
Source strain:
not specified
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Duration of treatment / exposure:
3m, 1h
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3m
Value:
ca. 10
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1h
Value:
ca. 6.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
This study was conducted to determine whether the test article, Dioctyltin di(acetate),
causes corrosion in the in vitro skin model EpiDermTM.
Duplicate EpiDermTM inserts were treated with test article, purified water (negative
control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At
the end of the treatment period, the tissues were washed with phosphate buffered
saline (PBS) and cell viability was assessed using the MTT assay. The skin
corrosivity potential was classified according to the remaining cell viability obtained
after test material treatment with either of the two treatment times.
Skin viability after a three minute or one hour exposure to the test article was 10%
and 6.3%, respectively.
The OD values for the negative controls met the acceptance criteria.
Skin viability after a three minute or one hour exposure to the positive control article
was 2% and 9.4%, respectively, demonstrating appropriate performance of the assay.
One positive control replicate was excluded from analysis due to loss of tissue during
wash off procedures. All data was calculated using the remaining replicate only.
The test article, Dioctyltin di(acetate), was considered to be corrosive (Category 1A)
according to the UN GHS classification system.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion