NA/750 FULL PUBLIC REPORT Reactive Orange DER 8089 1. APPLICANT Ciba Specialty Chemicals of 235 Settlement Rd., THOMASTOWN, VIC 3074 has submitted a standard notification statement in support of their application for an assessment certificate for Reactive Orange DER 8089. 2. IDENTITY OF THE CHEMICAL The chemical name, CAS number, molecular and structural formulae, molecular weight, spectral data and details of impurities present, along with the details of the Predicted Environmental Concentration (PEC) calculations have been exempted from publication in the Full Public Report and the Summary Report. Marketing Name: Reactive Orange DER 8089 Lanosol Black CE Cibacron Black LS-N Other Names: FAT 45' 176/A FAT 40' 560/A Lanosol Orange 8089 Method of Detection and Determination: UV/visible spectrophotometry Infrared spectrometry 1H nmr spectrometry reference spectra have been provided by the notifier 3. PHYSICAL AND CHEMICAL PROPERTIES The physical and chemical properties given below are for the product Orange DER 8089, containing > 50 % notified chemical, rather than for the notified chemical. The notified chemical is in a mixture of at least 29 reaction products (identified by HPLC) which are not individually isolated. Appearance at 20°C and 101.3 kPa: orange brown powder Melting Point: > 400°C (see comments below)
Number/sex of animals: 1 male, 2 female Observation period: 3 days Method of administration: 0.5 g of test material, moistened with bi-distilled water, was applied to a clipped intact region of the dorsal skin and secured under a gauze patch with a semi-occlusive dressing for 4 hours; at the end of this time residual material was removed with lukewarm water; animals were examined for skin reaction 1, 24, 48 and 72 hours following application of the test substance Test method: OECD TG 404 Observations: Draize scores were all zero at all time intervals; light orange staining of the treated skin persisted throughout the study Result: the notified chemical was not irritating to the skin of rabbits 9.1.5 Eye Irritation (Braun, 1997a) Species/strain: rabbit/New Zealand White Number/sex of animals: 1 male, 2 female Observation period: 14 days Method of administration: 0.1 g of test material applied as supplied into conjunctival sac of the left eye of each animal; the contralateral eye served as the control; animals were examined for eye lesions 1, 24, 48 and 72 after test substance application; further observations were made after 7 and 14 days Test method: OECD TG 405 Observations chemosis was observed in one animal and discharge was observed in all of the animals 1 hour after application of the test material; all Draize scores were zero for the remainder of the study; light orange staining of the conjunctivae and sclera of the treated eyes was observed in all animals at 24 and 48 hours; staining was restricted to the nictating membrane and lid hairs after this time; staining of the nictating membrane had cleared by day 14 Result: the notified chemical was not irritating to the eyes of rabbits 9.1.6 Skin Sensitisation (Maximisation Test) (Arcelin, 1997b)
Species/strain: guinea pig/Ibm: GOHI SPF Number/sex of animals: 10 males test group, 5 males control group Induction procedure: test group: day 1 day 8 to a clipped area of the scapular dorsal skin, each animal received 3 pairs of 0.1 mL injections as follows – 1:1 (v/v) mixture of Freund’s Complete Adjuvant and physiological saline the test material diluted to 5 % in bi-distilled water the test material diluted to 5 % by emulsion with 1:1 (v/v) mixture of Freund’s Complete Adjuvant and physiological saline a filter paper patch with 0.3 g of test material (50 % (w/v) in bi-distilled water) was placed over the injection area; covered with aluminium foil and secured with elastic plaster and impervious adhesive tape control the induction procedure was identical to that for the test group, except that water only was used in place of the aqueous solution of test material in both induction phases Challenge procedure: day 22 a 24 hour occluded application of 0.2 mL of a 25 % solution of the test material was applied to the shaved flank of both test and control animals Test method: OECD TG 406 Comment: no skin response to the challenge application of test material was observed in either the test or control animals Result: the notified chemical was not sensitising to the skin of guinea pigs 9.2 Repeated Dose Toxicity (Allard et al., 1997) Species/strain: rat/HanIbm: WIST (SPF) Number/sex of animals: group 1: 10/sex 2: 5/sex group 3: 5/sex group 4: 10/sex