Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Type of information:

other: Bibliographic source

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

According to skin irritation test, same possitive result is expected.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 31 August 2017 to 14 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD No. 439: In Vitro Skin Irritation. Reconstructed Human Epidermis Test Method, 28 July 2015

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Details on animal used as source of test system:

This test uses the EpiDerm reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human, i.e. the epidermis.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25 mg + 25 µL DPBSL

Duration of treatment / exposure:

60 min

Duration of post-treatment incubation (if applicable):

42 h

Number of replicates:

3

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 7.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Executive summary:

In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as "irritant" in accordance with UN GSH "Category 2".

Data source

Reference

Reference Type:

review article or handbook

Title:

ANTIMONY POTASSIUM TARTRATE

Author:

WN Harrison; SM Bradberry; JA Vale

Year:

2011

Bibliographic source:

UKPID MONOGRAPH

Materials and methods

Principles of method if other than guideline:

Occupational exposure study

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

28300-74-5

Molecular formula:

C8H4K2O12Sb2 ∙ 3H2O

Details on test material:

Trihydrate salt.

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

Occupational exposure to antimony compounds. Antimony spots being more severe in warm surroundings. They are symptomatic of excessive exposure to dirty working conditions

Results and discussion

In vivo

Results

Irritation parameter:

other: Irritant to the skin and eyes.

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Irritant to the skin and eyes. Exposure to high concentrations may produce severe eye irritation. "Antimony spots" (papules and pustules around sweat
and sebaceous glands) may develop after repeated exposure, particularly in warm conditions.