Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 August 2020 thru 21 August 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts

Molecular formula:

C33H66N3S6Sb to C51H102N3S6Sb

IUPAC Name:

Carbamodithioic acid, bis(mixed 2-ethylhexyl and 2-methylbutyl and pentyl) derivs., antimony (3+) salts

Test material form:

liquid: viscous

Specific details on test material used for the study:

PYSICAL DESCRIPTION: Highly viscous amber liquid.

PURITY: >99%

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: WT05-19
- Expiration date of the lot/batch: not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp.
- Stability under storage conditions: stable for the duration of testing.

In vitro test system

Test system:

human skin model

Source species:

other: reconstituted human skin

Vehicle:

unchanged (no vehicle)

Details on test system:

These procedures were based on the EpiDerm™ Skin Irritation Test (SIT) Kit instructions (MatTek document MK-24-007-0023, released 07/11/2014).

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

30 microliters

Duration of treatment / exposure:

These procedures were based on the EpiDerm™ Skin Irritation Test (SIT) Kit instructions (MatTek document MK-24-007-0023, released 07/11/2014).

Duration of post-treatment incubation (if applicable):

These procedures were based on the EpiDerm™ Skin Irritation Test (SIT) Kit instructions (MatTek document MK-24-007-0023, released 07/11/2014).

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Average

Value:

10.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Tissue-Type	Substance	Average Optical Density Reading	SD (Optical Density)	Average % Viability	SD (Viability)	CV (%)	Irritant/ Non-Irritant
Viable	Negative Control (DPBS)	2.030	0.110	100.0	5.40	5.40	Non-Irritant
	Positive Control (5% SDS)	0.060	0.011	2.9	0.55	18.73[1]	Irritant
	Test Item	0.215	0.015	10.6	0.73	6.95	Irritant

[1]Although the Positive Control CV (%) is 18.73% (slightly above ≤ 18%), the average % viability result of the test substance was 10.6%. The result of the test substance is ≤ 50%; therefore the test substance is considered an irritant.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance was found to be a skin irritant in the In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method).

Executive summary:

In an OECD 439 Guideline study conducted under GLP conditions using the in vitro Reconstructed Human Epidermis test model, the test substance was found to be a skin irritant. The reliability of this model for substances of this type is not known. Other similar substances have been found to be non-irritating in vivo.