Dioctyltin di(acetate)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Cross-reference

Reason / purpose for cross-reference:

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

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.