Registration Dossier

Administrative data

Description of key information

Skin irritation
In a preliminary in vitro study using the EpiDerm human skin model test, it was concluded, that 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate does not show a corrosive potential.
Skin irritation/corrosion of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate was investigated in an in vivo test in rabbits. Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.3 and 0.7 for erythema and 0.0 for edema. Thus, the test substance is not irritating to the skin.
Eye irritation
In an in vivo eye irritation study in rabbits 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate was shown to be not irritation to the eye.
The results of the in vivo eye irritation tests were confirmed by a preliminary in vitro HET-CAM test and an Isolated Chicken Eye (ICE) test both showing no indication of severe eye irritation.
Respiratory irritation
No data available

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)

Additional information

There are reliable studies availably to assess the potential of the test substance for skin and eye irritation.

Skin irritation

A preliminary in vitro study using the EpiDerm human skin model as described in OECD 431 showed the non-corrosivity of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate (GLP; BASF AG 2006). The test substance did not reduce the cell viability relative to the negative control after 3 min and 1 h, respectively, while the treatment with the positive control substance, 8n potassium hydroxide, produced valid reactions.

In order to further assess the acute skin irritation potential of the test substance, a GLP conform dermal irritation/corrosion test in White New Zealand rabbits was performed according to the method described in OECD guideline 404 (BASF AG 2006). An amount of 0.5 g of the test substance was applied for 4 hours to the intact skin of three rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch.

Slight or moderate erythema were observed in all animals during the observation period. The cutaneous reactions were reversible in all animals within 72 hours after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 1.0, 0.3 and 0.7 for erythema and 0.0 for edema.

Considering the described cutaneous reactions as well as the average score for irritation, 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate does not show a skin irritation potential under the test conditions chosen.

Eye irritation

In a preliminary GLP conform in vitro study using the chorionallantoic membrane in incubated hen eggs (HET-CAM test) 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate did not produce changes indicative for severe eye irritation; neither haemorrhagia nor coagulation was detected during the observation period of 3.5 minutes (BASF AG 2006). This result is also confirmed by an Isolated Chicken Eye (ICE) also showing no eye damaging effects (TNO, 2006).

In order to further assess the acute eye irritation potential of the test substance an GLP conform eye irritation test in rabbits was performed according to the method described in OECD guideline 405 (BASF AG 2006). An amount of 0.1 mL bulk volume (about 26 mg) of the test substance (purity: 93.0 weight-%) was applied to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 1 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application.

Slight or moderate conjunctival redness, slight conjunctival chemosis and slight discharge were observed in the animals during the observation period. In addition, injected scleral vessels in a circumscribed area were noted in a single animal after 1 hour, only. The ocular reactions were reversible. One animal had recovered by 24 hours (all scores "0" for cornea, iris and conjunctiva). A second animal had recovered by 48 hours, and the third by 72 hours. Mean scores calculated for each animal over 24, 48 and 72 h were 0.0 for corneal opacity and for iris lesions,1.0/0.3/0.0 for redness of the conjunctiva and 0.3/0.0/0.0 for chemosis.

Considering the described ocular reactions as well as the average score for irritation, 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate does not show an eye irritation potential under the test conditions chosen.

Respiratory irritation

No data available

Justification for classification or non-classification

Skin and eye irritation:

Based on the available in vivo and in vitro studies, there is no indication for an irritating potential of the test substance on skin or eyes. Thus, no classification is warranted according to 67/548/EEC and Regulation (EC) No 1272/2008 (GHS, CLP) respectively.

Respiratory irritation:

No data available