Registration Dossier

Administrative data

Description of key information

- Skin irritation: Not irritating; no classification is required. 
Two studies (Klimish score 2) were available on the substance and are used as a weight of evidence approach because they were conducted on diluted product.
One study (Klimish score 2) was available on analogue substance (reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda) (read-across approach) and is used as a supporting study.
- Eye irritation: Severely irritating; Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE and Eye Damage, Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eyes damages at the end of the observation period (21 days).
Two studies (Klimish score 2) were available on the substance. One study was used as a key study and the other one used as supporting.
- Respiratory tract irritation: signs of irritation of the respiratory tract in the acute inhalation study (see 7.2.2 Ac. inh. rat V2 1987 BASF) and reporting of respiratory irritation cases in Human with the analogue substance Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda) (read-across approach (see 7.10.5 exposure related observation in humans: manufacturing plant)

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation/corrosion:

Two studies (Klimish score 2) were available on the substance and are used in a weight of evidence approach because they were conducted on diluted product.

One study (Klimish score 2) was available on analogue substance (reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda) (read-across approach) and is used as a supporting study.

Studies on the registered substance:

The substance has been tested for dermal irritation in rabbits, according to O.E.C.D. guideline Nb.404. 0.5 g of the test article was applied as a 50% aqueous dispersion to 3 rabbits under a semiocclusive dressing for 4 hours. Skin sites were then scored for erythema and edema 24 and 72 hours after patch removal. Irritation was scored.

4 hours after removing the test substance, one animal showed erythema with score 1 which was reversible by 24 hours.

Under the experimental conditions of this study, the test item, diluted at 50 %, was not irritant when applied topically to rabbits. Based on these results, the undiluted test item Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is expected not to be irritant and thus is considered not to require classification for skin irritation according to Annex VI of the Directive 67/548/CEE and to EU Regulation 1272/2008 (CLP).

In a primary dermal irritation study (1971), Albino rabbits (12 animals) were dermally exposed to 0.5 ml of test article (22% active ingredient).

Intact and abraded test sites were covered with an occlusive dressing for 24 hours. Skin sites were then scored for redness and swelling 24 and 72 hours after patch removal. Irritation was scored.

On intact skin, no irritant effect was observed at 24 and 72 hours in all the animals. On scarified skin, only redness (score 1 or 2) was observed at 24 hours in 3 animals and was present in 5 animals at 72 hours. 

Under the experimental conditions of this study, the test material, containing 22% active ingredient, was not irritant when applied topically to rabbits. Based on these results, the registered Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda at 100% is expected not to be irritant and thus is considered not to require classification for skin irritation according to Annex VI of the Directive 67/548/CEE and to EU Regulation 1272/2008 (CLP).

Study on an analogue substance :

In a primary dermal irritation study (1994), New Zealand Albino rabbits (3 animals) were dermally exposed to 0.5 g of undiluted test article. Intact and abraded test sites were covered with an occlusive dressing for 4 hours. Skin sites were then scored for erythema and oedema 3 min, 1 hour, 4, 24, 48, 72 hours and day 7 after patch removal. Irritation was scored by the method of Draize. Mean scores over 24, 48 and 72 hours for each animal were 0.0,0.33and 1.7 for erythema and 0.0,0.33and 1.0 for edema. Similar effects were observed with abraded skin. The modified primary irritation index is1.17. Under the experimental conditions of this study, the test item was slightly irritant when applied topically to rabbits.Based on these results, the test item reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is not classified as irritating to the skin according to Annex VI of the Directive 67/548/CEE and to EU Regulation 1272/2008 (CLP).

In conclusion, both the registered substance diluled at 22% or 50% and its analogue "Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda" tested undiluted showed no to slight irritation when applied on rabbit skin. Therefore, the registered substance is not classified as irritating to the skin according to Annex VI of the Directive 67/548/CEE and to EU Regulation 1272/2008 (CLP).

Eye irritation:

Two studies (Klimish score 2) were available on the substance. One study was used as a key study and the other one used as supporting:

In the key study (1987), the substance has been tested for eye irritation in rabbits, according to O.E.C.D. guideline Nb.405. 0.1 ml of the test article was instilled in the eye of White rabbits (3 animals). Animals were then observed for 21 days. Irritation was scored.

The substance was found to be severely irritating to the eye in the rabbit. Persistence of eye damages at the end of the observation period (21 days) was observed. Mean scores calculated for each animal over 24, 48 and 72 hours were 1.0, 1.0 and 1.0 for corneal opacity; 0.33, 0.0 and 0.0 for iris lesions; 2.0, 2.0 and 2.0 for redness of the conjunctiva and 0.66, 1.0 and 0.0 for chemosis.

Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit. Based on these results, the test item reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is classified Xi, R 41, risk of serious damage to eyes, according to Annex VI of the Directive 67/548/CEE and Eye Damage, Cat 1, H318 according to EU Regulation 1272/2008 (CLP), considering the persistence of eyes damages at the end of the observation period (21 days).

In the supporting study (1971), 0.1 ml of the test article was instilled into the pit of one eye of Albino rabbits (6 animals). The other eye is untreated and acts as a control. 24, 48 and 72 hours later the eyes are checked for reactions using a magnifying glass and hand lamp. After the 24 hour value has been determined one drop of fluorescein solution according to DAB is applied directly onto the cornea. After the excess fluorescein solution has been washed off with physiological saline solution the damaged parts of the cornea appear yellow, particularly in a dark room with UV lighting.

The compound caused distinct irritation of the mucosa of the eye in the rabbit.

Under the experimental conditions of this study, the test item was found severely irritating to the eye of rabbit.

Irritant effects of the respiratory tract:

The irritant effects on the respiratory tract of Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda in its solid form is determined based on effects reported in the acute inhalation toxicity study and by a read-across approach using the analogue substance Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda:

- In an acute inhalation study (1987), clinical signs indicative of a potential irritant effect on the respiratory tract were observed in rats exposed to the test substance as dust aerosol for 4 hours. These were characterized by accelerated respiration, irregular and intermittent respiration, reddish discharge from nose and/or respiratory sounds noted at 3.49 and 4.76 mg/L (mid and high doses). At necropsy dead animals from the high dose group showed a lung filled with blood and edema.

- Case of irritant effects of the respiratory tract were reported in workers manipulating powder of Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda in the manufacturing plant. Owing to its structure similarity, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is expected to display comparable effects when handled it its powder form.


Justification for selection of skin irritation / corrosion endpoint:
Two studies available on the substance, one study available on analogue substance.

Justification for selection of eye irritation endpoint:
Two studies available on the substance.

Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP3.

Self classification:

Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is not classified for skin irritation according to the Regulation (EC) 1272/2008 (CLP) and to the Directive 67/548/EEC.

Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is classified as Eye Damage Cat. 1, H318 according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R41 according to the Directive 67/548/EEC, considering the persistence of eyes damages in rabbit at the end of the observation period (21 days).

Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda is classified as STOT-SE 3, H335 according to the Regulation (EC) 1272/2008 (CLP) and as Xi, R37 according to the Directive 67/548/EEC considering the irritant effects on the respiratory tract observed in the acute inhalation study in rat and the human cases reported in the manufacturing plant during the handling of the solid form of the analogue substance "Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda".