Benzene-1,3,5-tricarbonyl trichloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

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 skin corrosion, leading to classification as serious eye damage (Category 1)

the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)

other:

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.2, the study for serious eye damage/eye irritation in vitro, does not need to be conducted since the substance is a strong acid (pH ≤ 2.0 in water) and/or the substance is classified under Regulation (EC) 1272/2008: Skin Corrosive: category 1 thereby leading to classification as serious eye damage (Category 1). According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2.7, July 2017) the study does not need to be conducted.

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

acidity / alkalinity

Remarks:

(1) pH and/or (2) acidity/alkalinity per OECD TG 122: Determination of pH, Acidity and Alkalinity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-03-2022 to 28-04-2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

GLP compliance:

yes (incl. QA statement)

Reagent:

NaOH solution

Details on titrant used:

- Volume of titrant used: 11.6070 mL 0.2 N NaOH solution for acidity measurement (i.e. 0.2 mol/L NaOH solution)
- Titer of titrant used: See above.
- Other: At 0.1%w/v concentration in water, since the test item did not fully dissolve in water and, thus, could not be titrated it was pre-treated with 10 mL acetone prior to adding 100 mL deionised water. The mixture was left stirring overnight to ensure the test item was fully dissolved.

Key result

pH value:

1.97

Temp.:

20 °C

Concentration:

1 other: %w/v dilution in water

Remarks on result:

other: mean (n=2) pH ; pH range 1.96 to 1.98 ; temperature: 20 ± 1 °C ; 1% (w/v) dilution in water per OECD TG 122

Key result

Acidity or alkalinity:

acidity

Value:

111

Remarks on result:

other: units: %m/m Acidity, calculated as H2SO4 ; concentration: 0.1%w/v dilution into water; test item pre-treated with 10 mL acetone prior to dilution in 100 mL water due to limited solubility per OECD TG 122

pH:
The pH values in duplicate were measured using the combined glass electrode and the pH was determined to be 1.96, and 1.98, respectively. The mean pH was 1.97.

Acidity:
The acidity of test item calculated as H2SO4, was determined to be 111 %m/m calculated as H2SO4 when the test item was pre-treated with 10 mL acetone prior to diluting in 100 mL deionised water. The amount of titrant 0.2 N sodium hydroxide solution used was 11.6070 mL

Applicant assessment indicates, when added to water the test item forms a highly acidic solution of pH < 2.0.

Conclusions:

The pH values in duplicate were measured using the combined glass electrode and the pH was determined to be 1.96, and 1.98, respectively. The mean pH was 1.97. The acidity of test item calculated as H2SO4, was determined. The amount of titrant used 0.2 N sodium hydroxide solution was 11.6070 mL. The acidity of the test item was determined to be 111 %m/m calculated as H2SO4 when the test item was pre-treated with 10 mL acetone prior to diluting in 100 mL deionised water.

Executive summary:

The pH and/or acidity/alkalinity properties of the test item was determined in a OECD TG 122 study using electrometric end point determination under GLP. The pH was measured using a 906 Titrando and a combined glass electrode using a test item 1%w/v aqueous solution at 20 ± 1 °C. The pH meter was calibrated using three commercially available buffer solutions pH 4, pH 7 and pH 10. At the start and at the end of the measurements, pH of the buffer solution at pH 7 was measured to ensure proper performance of the pH meter. The determination of the acidity or alkalinity of the test item was performed if the pH of the test item or a 1% (w/v) dilution in water is < 4 or > 10 and if the test item is sufficiently soluble in water or acetone/water mixtures. 0.1029 g test item was accurately weighed into a titration vessel and dissolved in 100 mL deionised water under stirring. Since the test item did not fully dissolve in water and, thus, could not be titrated it was pre-treated with 10 mL acetone prior to adding to the 100 mL deionised water. The mixture was left stirring overnight to ensure the test item fully dissolved. After homogenization, the solution was titrated electrochemically to pH 7 at ambient temperature while stirring. To achieve this, a 0.2 N standardized sodium hydroxide solution (t mL) was used at 20 ± 1 °C. The test was performed in duplicate (n=2). The pH values in duplicate were measured using the combined glass electrode and the pH was determined to be 1.96, and 1.98, respectively. The mean pH was 1.97. The acidity of test item calculated as H2SO4, was determined. The amount of titrant used 0.2 N sodium hydroxide solution was 11.6070 mL. The acidity of the test item was determined to be 111 %m/m calculated as H2SO4 when the test item was pre-treated with 10 mL acetone prior to diluting in 100 mL deionised water.