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Administrative data

Description of key information

3-Aminobenzenesulfonic acid is considered slightly irritating in the skin irritation test in rabbits. Furthermore, 3-Aminobenzenesulfonic acid is not irritant to skin in the Human Skin Model Test.
3-Aminobenzenesulfonic acid is not irritating in the eye irritation test in rabbits. Furthermore, 3-Aminobenzenesulfonic acid is not corrosive / not severe irritant to the eye in the BCOP assay.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In a non-GLP skin irritation test according to guideline similar to OECD 404, the flanks of 6 New Zealand White rabbits were clipped 24 before start of treatment on both sides of the trunk (​​approx. 8 x 8 cm) (Fraunhofer-Institut 1981). The skin of the right flank at the receiving location for the test patch was additionally scarified by a Schröpfschneppers. 2.5 x 2.5 cm patches of double layers of surgical gauze were soaked in 500 mg of metanilic acid wet suspended in water and covered with indifferent, impermeable PVC film (5 x 5 cm). The film with the underlying patch was fixed by skin-friendly adhesive tape (Leukoflex ®). Subsequently, the total trunk of the animals was wrapped with an elastic duration bandage (EloflexR) during 24h exposure time. Examinations were made 24, 48, 72 hours and 8 days after start of treatment. The irritation index was based on the 24 and 72 hours scores. At 24 and 72 hours erythema score of 1.83 and 1.17, respectively, was found in the intact skin and respectively 2.17 and 1.0 in the abraded skin. The edema score showed a score of 0.5 in the intact skin, and in abraded skin 0.33 at 24 hours. Edema was fully reversible within 72 hours. After 8 days still weak erythema was observed. Primary irritation was 1.8. Based on these observation the test substance is considered slightly irritating.

In a GLP-compliant in vitro study according to OECD guideline 439 the irritation potential of the test item was assessed by means of the Human Skin Model Test (Harlan CCR 2012). Three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes. Approximately 25 mg of the test item were applied to each tissue, wetted with 40 μL DPBS, and spread to match the tissue size. 30 μL of either the negative control (DPBS) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue. After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD ≥ 1.0 and ≤ 2.5 for the 60 minutes treatment interval thus showing the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval thus ensuring the validity of the test system. After treatment with the test item the mean relative absorbance value decreased to 93.8% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin according to UN GHS and EU CLP regulation.

Eye irritation

In a non-GLP in vivo eye irritation test according to guideline similar to OECD 405, 6 New Zealand White rabbits were administered 100 µL of 3 -Aminobenzenesulfonic acid substance in the right lower eyelid (Fraunhofer-Institut 1981). The eyes were not rinsed after application. The left eye remaind untreated and served as control. Observations on cornea, iris and conjunctiva were performed 24, 48 and 72 hours and 8 days after the start of treatment. The mean cornea score and iris score for all time points were 0.0. The mean conjunctivae score at 24, 48 and 72 hours were respectively 8, 6, 1.67 with fully reversibility at 8 days. The primary irritatation score was 5.2 (24-72 hours). Based on these observations 3 -Aminobenzenesulfonic acid is considered to be not irritating to the eye.

A GLP-compliant in vitro study was performed according to OECD 437 guideline, to assess the corneal irritation and damage potential of 3-aminobenzenesulphonic acid by means of the BCOP assay using fresh bovine corneae (Harlan CCR 2012). After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water of the test item, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained MEM medium supplemented with sodium bicarbonate and L-glutamine and 1% fetal calf serum (FCS) (complete medium = cMEM). After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (10% (w/v) Benzalkonium chloride in saline showed clear opacity of the corneae corresponding to a classification as corrosive / severe irritant to the eye (CLP/EPA/GHS (Cat 1)). Relative to the negative control, 3 -Aminobenzenesulfonic acid did not cause any increase of the corneal permeability. Slight opacity effects could be observed. The calculated mean in vitro irritation score of 19.83 was below the threshold of ≥ 55.1. Therefore the test item is classified as not corrosive / not severe irritant to the eye according to OECD 437. In conclusion, according to the current study and under the experimental conditions reported, 3 -Aminobenzenesulfonic acid is not corrosive / not severe irritant to the eye (CLP/EPA/GHS (Cat 1)).

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified as irritating to the skin and eye according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.