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EC number: 825-609-6 | CAS number: 98458-83-4
Two reliable studies are available for the analogue 1,3-H6XDI. The data are read across to 1,4-H6XDI.
No signs of ill health or toxicity were noted. Bodyweight increases in test group animals were comparable to control group animals.
Intradermal injections resulted in necrosis at sites receiving Freund's Complete Adjuvant in test and control animals. Slight irritation was seen in test animals at sites receiving Takenate 600, 0.01% v/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.
Slight erythema was observed in test animals following topical induction application with Takenate 600, 20% v/v in Alembicol D. Slight erythema was seen in the control guinea pigs.
After challenge, dermal reactions (erythema and oedema) were seen in all of the ten test animals at 24 and 48 hours after challenge, compared to none in the controls. Well-defined erythema was seen in 9/10 animals, in one animal slight erythema was seen.
Oedema formation was slight in one animal, well-defined (edges of area well-defined by definite raising) in 6 animals and moderate (raised approximately 1 mm) in 3 animals.
A skin sensitising test in guinea pigs was performed according to OECD guidance and GLP principles. Based on a dose range finder experiment, concentrations for intradermal injection, topical application and challenge application were established at 0.01% v/v, 20% v/v and 2.5%/5% v/v Takenate 600. No signs of ill health or toxicity were noted. Bodyweight increases in test group animals were comparable to control group animals. After challenge, dermal reactions (erythema and oedema) were seen in all of the ten test animals at 24 and 48 hours after challenge, compared to none in the controls. Well-defined (or slight) erythema was seen in 10/10 animals.
For substance analogue 1,3-H6XDI, two studies are available, both performed according to OECD/EC test guidelines and GLP principles. In the first study, a skin sensitising test in guinea pigs, after challenge, dermal reactions (erythema and oedema) were seen in all of the ten test animals at 24 and 48 hours after challenge, compared to none in the controls. In the second, a test for delayed contact hypersensitivity was performed with 1,3-XDI according to Magnusson and Kligman (1970). Challenge resulted in slight to severe dermal reactions (erythema and oedema), in part accompanied by thickening, dryness and sloughing of the skin in 9/10 test animals. Only slight skin effects were seen in one control animal. Based on these data, 1,3-XDI was found to be a skin sensitiser.
These results are read across to 1,4 -H6XDI.
In accordance with the ECHA Guidance document "Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance" of July 2017, diisocyanates need to be considered for classification as a respiratory sensitiser. In the scientific literature diisocyanates are identified as chemicals causing the development of occupational asthma after workplace exposure. There are no data available that show that such a classification is not warranted for 1,4-H6XDI.
Based on the available studies on a substance analogue, 1,4-H6XDI is classified cat.1A for skin sensitising properties according to the CLP Regulation (EC) No. 1272/2008.
As 1,4-H6XDI is a diisocyanate, it is classified according to the CLP Regulation (EC) No. 1272/2008 and ECHA Guidance as
a respiratory sensitiser cat. 1.
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