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Description of key information

Sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in a primary skin irritation study according to OECD guideline 404 and EU method B.4. The test item was not irritating to rabbit`s skin.  Furthermore, a phototoxicity test was carried out according to the CTFA Safety Testing Guidelines with 15 female Albino Hartley guinea pigs. It can be concluded that the test article sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate does not exhibit a photoirritating potential in the guinea pig. No elevated number of animals with erythema was observed compared to only UV-A treated control animals.
Sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in two primary eye irritation studies according to OECD giudeline 405 and EU method B.5. In both studies, the test item was severly damaging to rabbit`s eyes.

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:
adverse effect observed (irritating)

Additional information

Skin iritation/corrosion:

Sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in a primary skin irritation study (Ciba, 1988) according to OECD guideline 404 and EU method B.4. The single dose of 0.5 g/animal of test item was placed on the skin of rabbits (1 male; 2 females). The test item was found to cause a primary mean irritation score of 0.0 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema. In the area of application, no staining of the treated skin by pigment or coloring of the test article was observed. The test item was not iritating to rabbit`s skin.

In order to assess the cutaneous phototoxic potential of sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate a phototoxicity test (Ciba, 1997) according to the CTFA Safety Testing Guidelines was carried out in 15 female (10 test and 5 control) Albino Dunkin Hartley guinea pigs.

It can be concluded that the test article sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate does not exhibit a photoirritating potential in the guinea pig under the study conditions.

Eye irritation:

In the first study (CIBA, 2001) the eye irritation potential of sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was assessed in rabbits according to OECD guideline 405 and EU method B.5. The test item was instilled into one eye of one rabbit . The eye was examined for 21 days, to assess the grade of ocular reaction.

Instillation into the eye caused practically no initial pain (class 1 on a 0-5 scale). Slight or mild comeal opacity (mean score of 1.67 (24/48/72 h)), involving the whole cornea, was seen from 1 day after instillation and was still present after 21 days. There were no iridial effects ( mean score of 0 (24/48/72 h)). Conjunctival effects consisted of slight or moderate redness (mean score of 1.67) for up to 4 days, slight or mild chemosis (mean scroce of 1.33) for up to 4 days and a slight or moderate discharge for up to 7 days.

Additional signs of irritation consisted of lachrymatory, mucoid and Harderian discharge; irregular corneal surface and raised comeal opacity; erythema, oedema, thickening and convolution of the eyelids; dried secretion around the periorbital skin and neovascularisation (the latter covering in excess of 14 of the comea). Effects were still apparent 21 days after instillation and there was little evidence of recovery.

The animal was humanely killed and no further animals were dosed.

The test item is thus judged to be severely damaging to the rabbits eye.

In a second study (CIBA, 1988), sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in a primary eye irritation study according to OECD giudeline 405 and EU method B.5. The single dose of the test item (0.1 g per animal) was placed in the conjunctival sac of rabbit eyes. The test item was found to cause a mean cornea score of 1 (24/48/72 h), a mean iris score of 1 (24/48/72 h), a conjunctivae score of 2 (24/48/72 h) and a chemosis score of 0.63 (24/48/72 h).The test item was found to cause a primary irritation score of 4.3, when applied to the rabbit eye mucosa. No staining of the cornea and conjunctivae of the treated eyes by pigment or of test item was observed. Slight corrosion on the cornea was observed in all animals within 48- to 72 hours. The test item is severly damaging to rabbit eye, as irritation of one animal is irreversible within 21 days.h


Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, the test substance is not classified with regard to skin irritation according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.

Based on the available data, the test item has to be classified with regard to eye irritation according to Direcetive 67/548/EEC (DSD) with R41 (Irritant, Risk of serious damage to eyes) and Regulation (EC) No 1272/2008 (CPL) with eye damage (class 1), H318 (causes serious eye damage) .

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