Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts

Endpoint summary

Description of key information

Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts as present in commercial form (31-32% active substance in aqueous solution) was shown to be an irritant in vitro (OECD TG 439) but not corrosive (OECD TG 431). Taken together the results indicate that the substance as supplied would be classified as a category 2 skin irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 November 2020 - 27 November 2020

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

ColaTeric CNA-40 batch/lot # 775OI19
31.5% active substance in aqueous solution.

Test system:

human skin model

Source species:

human

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 minutes

Value:

0.176

Negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

ColaTeric CNA-40 was classified as an irritant to the skin.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 February 2021 - 25 February 2021

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Cola®Teric CNA-40
Batch/Lot # 2093C20
Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3(hydroxyethyl), hydroxides, sodium salts 31.5 % w/w; Water 68.5 % w/w

Test system:

human skin model

Source species:

human

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

57.85

Negative controls validity:

valid

Positive controls validity:

valid

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minutes

Value:

88.388

Negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

ColaTeric CNA-40 was evaluated for skin corrosion using EpiDerm tissue model following OECD TG 431 and was found to be Non-corrosive

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

06 July 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

a. Category definition
A category of six analogues is defined for the purpose of data-gap filling of acute toxicity by the oral route (as LD50). The analogues are shown in the attached Category Report file.
b. Hypothesis for grouping chemicals
The working hypothesis is that the selected analogues can be grouped together for the prediction of eye irritation. The hypothesis is based on the profilers’ outcome, which supports the assumption that the analogues are structurally related and share similar reactivity. The grouping approach is described further in the attached Prediction Report.
c. Category description
• The category members are tertiary amines that are > 50% structurally similar to the target chemical.
• The covered molecular log Kow range is from -2.08 to 3.69 and the target chemical is within the range. A data matrix report is listed in an attached excel file.

The prediction is based on 9 values, 3 of them (33.3%) equal to predicted value
Prediction confidence is measured by the p-value: 0.00567.

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

OECD Toolbox Read-Across (grouping approach)

GLP compliance:

not specified

Remarks on result:

probability of mild irritation

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on read-across data, EC No. 273-535-2's main (C12) component is a category 2 eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)