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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
rabbit, 4 h semiocclusive: irritant (GLP, OECD 404; BASF 2004)
rabbit, 24 h occlusive: moderately irritant (Moreno 1976, Val. 4)
Eye
rabbit, rinsed after 24 h: not irritant (GLP, OECD 405; BASF 2004)
in vitro HET-CAM: not corrosive (standardized test protocol according to Luebke 1985/ Spielmann 1995/ Spielmann et al. 1996; BASF 2004)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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

skin

In a GLP conform in vivo study according to OECD 404, clipped skin of three New Zealand White rabbits were exposed to 0.5 mL unchanged test substance (purity 99.1area%) for 4 hours under semiocclusive conditions. Slight to moderate erythema were observed which were not fully reversible within the observation period of maximum 14 days. Erythema scores were 2.33, 2.33 and 1.67 for the three test animals during the relevant reading period (24 -72 h). Corresponding mean edema scores were 0.0 for all animals. At the final reading, erythema (in 2/3 animals) and scaling (1/3) extended beyond the area of exposure (BASF 2004).

In a poorly reported skin irritation test with rabbits, the unchanged test substance caused moderate irritation effects to intact or abraded rabbit skin for 24 hr under occlusion. No further details were reported (Moreno, 1976, Val. 4).

eye

In a GLP conform in vivo study according to OECD 405, 100 µL of the unchanged test substance (purity 99.1 area%) were instilled into one eye of three New Zealand White rabbits. The treated eyes were rinsed after 24 h. No corneal opacity, iritis or chemosis was observed during the observation period of 72 h (score 0 according to the OECD/Draize scheme). Slight to moderate conjunctivae redness was observed which was completely reversible within 72 h; the mean score was 0.67 during the relevant reading period (24 -72 h; BASF 2004).

In addition, an standardized in vitro test was performed using hen’s egg chorio allantoic membranes as tissues for the corrosive/ severe eye irritation potential of substances (according to Luepke ,1985, Spielmann, 1995, and Spielmann et al., 1996). The undiluted test substance caused haemorrhagia in 1/3 eggs 153 seconds after application and coagulation in 3/3 eggs 235 seconds after application (mean). No haemorrhagia and coagulation were observed during the observation period of 5 minutes if the test substance was applicated as 10% dilution in olive oil. In conclusion, the test substance did not produce changes indicative for corrosion (BASF 2004).


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

According to the results of the available test, the test substance has to be classified as skin irritant (R38 following 67/548/EEC requirements and skin irritation Cat. 2 following GHS requirements, respectively).

According to the available test results, the test substance has not to be classified as eye irritant following 67/548/EEC and GHS requirements, respectively.