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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

skin irritation
in vivo, rabbit: not irritant (GLP, OECD 404; BASF AG 1997)
eye irritation
in vivo, rabbit: not irritant (GLP, OECD 405; BASF AG 1997)
respiratory irritation
no data available

Key value for chemical safety assessment

Additional information

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

 

skin irritation

In order to 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 1997). An amount of 0.5 g of the test substance (purity: 97.9 %) 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 average score (24 to 72 hours) for irritation was calculated to be 0.2 for erythema and 0.0 for edema. The skin findings were reversible in all animals within 72 hours after removal of the patches; thus the study was terminated.

Considering the described cutaneous reactions as well as the average score for irritation, MGDN does not show a skin irritation potential under the test conditions chosen.

 

eye irritation

In order to 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 1997). An amount of 0.1 mL bulk volume (about 41 mg) of the test substance (purity: 97.9 %) was applied to one eye of three White New Zealand rabbits. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 24, 48 and 72 hours after application.

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.4 for conjunctivae redness. The findings were reversible in all animals within 72 hours after application; thus the study was terminated.

Considering the described ocular reactions as well as the average score for irritation, MGDN 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, EU-GHS and OECD-GHS, respectively.

respiratory irritation

No data available