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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 July 2020 thru 19 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

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.

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

EpiOcular tissue construct designed to medel the cornea epithelium with progressively stratified, but non-cornified cells.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50 micro-liters

Duration of treatment / exposure:

30 min

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

2

Details on study design:

- RhCE tissue construct used, including batch number : MatTek Corporation EpiOcular EIT MK-24-007-0055, released 02/10/2017
- Negative Control: deionized water
- Positive Control: methyl acetate
- Doses of test chemical and control substances used : 50 micro-liters
- Optical density (OD) was read in a 96-well plate spectrophotometer using a wavelength of 570 nm without using a reference filter

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

Average Viability (%)

Value:

82.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Substance	Average Optical Density Reading	SD (Optical Density)	Average % Viability	SD (Viability)	Irritant/ Non-Irritant	GHS Category
Test Item	1.883	0.014	82.6[1]	0.61	Non Irritant	No Category
Freeze Killed - Test Article	0.299	0.038	13.1	1.67	-	-
Freeze Killed – Negative Control	0.041	0.001	1.8	0.03	-	-
Negative Control (deionized water)	2.279	0.049	100.0	2.14	Non Irritant	No Category
Positive Control (methyl acetate)	0.888	0.167	39.0	7.32	Irritant	2

[1]The corrected % viability of the test article was calculated to be 71.285%.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was not an eye irritant in the in vitro EpiOcular reconstructed human cornea-like epithelium (RhCE) Eye Irritation Test.

Executive summary:

In an OECD Method 492 Guideline study conducted under GLP conditions using the in vitro EpiOcular reconstructed human cornea-like epithelium (RhCE) Eye Irritation Test, the test item did not produce a significant irritation response. Average viability of the tissue was 82.6% (corrected to 71.285%) following treatment with the test item.