Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 407-240-9
CAS number: 159604-94-1
BLUE 10 25 964
The data presented in this dossier only allow a qualitative of the toxicokinetic behaviour of Blue 10 25 964.However, a couple of significant conclusions can be made.Physico-chemical data:Blue 10 25 964 is a blue powder, which serves as a basic dyestuff for paper tissues. The substance has a MMD < 22 um(50% mass below or equal to 22 um). The water solubility was determined to be greater than 300000 mg/L.Toxicological data:Blue 10 25 964 was tested for its acute oral and dermal toxicity properties, for subacute oral toxicity and forirritant effects on skin and eyes. The potential to cause skin sensitization was evaluated with the Maximisation Test.Two mutagenicity tests were performed with Blue 1025 964 .In the tests for acute oral and dermal toxicity, the substance was applied to Wistar rats at a single dose levelof 5000 and 2000 mg/kg body weight respectively. The substance was "not classified" according to the EU classification criteria.Deaths occurred during the acute oral toxicity test, both in male and female rats. All deaths occurred within the firstfour hours of dosing. Macroscopic examination revealed a blue staining of stomach and intestine. Lethargy and/orconvulsions were seen in about half of the animals during the first day. Piloerection was also occasionally seen during this time.In the acute dermal toxicity test no macroscopic findings at necropsy were recorded. No clinical signs of toxicity wereobserved during the study period. No deaths occurred during the test. Erythema was observed in 1 male and 1 female overthe first 3-4 days at the treatment site. Blue staining was also observed and had disappeared by day 12-13. All animalsshowed body weight gain over the study period.In the skin irritation test, no clinical signs of systemic toxicity were noted and no mortality occurred. The observedskin irritation consisted of very slight erythema in all three animals. The irritation was reversible within 24 hoursafter exposure in all three animals. The test item caused a blue staining of the treated skin in all three animals. This was noted 45 minutes after test item exposure.Coloration disappeared in one animal at 24 hours. Neither alterations of the treated skin were observed nor werecorrosive effects evident on the skin.According to EU-criteria the substance is not irritating to the rabbit skin.The instillation of Blue 10 25 964 into the eye affected the cornea and the iris of one animal and affected theconjunctivae of all three animals. The opacity of the cornea was reversible within 7 days and the injection of the iriswithin 48 hours in one animal. The irritation of the conjunctivae was reversible within 14 days in all three animals. Blue discoloration and/or adherence of the test item in the treated eye were observed in all three animals.There was no evidence of ocular corrosion.According to EU-criteria the substance is not irritating to the rabbit eye.Blue 10 25 964 was found to be a sensitizer according to the Maximisation sensitization test.The epidermal exposure resulted in seven positive sensitization reactions in response to the 5% concentration.This corresponds to a sensitization rate of 35%. The reactions were characterized by redness and scaliness. Nosymptoms of systemic toxicity nor mortality were observed in all animals. Therefore, according to EU-criteria thesubstance is sensitizing to guinea pig skin.In the subacute toxicity test, repeated oral (gavage) administrations of Blue 10 25 964 to Wistar rats at doses of50, 200 and 1000 mg/kg/day for 28 days resulted in no mortality, no clinical signs of toxicological relevanceduring weekly observations or during functional observational battery, no effects on the body weight andbody gain, no effects on haematology, clinical biochemistry or urinalysis, no effects on organ weights and on microscopic/macroscopic findings. No effects were seen in the eye following ophthalmological examination. Dark feceswere recorded in all treated animals from day 5 of treatment until termination. The macroscopic examination revealed noblack appearance of gastro-intestinal tissue. Based on the results of the repeated dose oral toxicity, the no observed-adverse-effect-level (NOAEL) of Blue 10 25 964 was determined to be 1000 mg/kg/day body weight.Because of the possibility of release of 3,3'-dihydroxy-benzidine, known for its genotoxic effects, from metabolism, a Prival-Mitchell modified Ames Test was conducted. The bacterial reverse mutagenic assay showed that the item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.Therefore, Blue 10 25 964 is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reversemutation assay.In the mammalian bone marrow Micronucleus Assay (in vivo), Blue 10 25 964 did not induce micronuclei in the bone marrowcells of mouse. No increase in the frequency of micronucleated polychromatic erythrocytes was observed.Absorption and metabolism:Blue 10 25 964 is characterized by a very high water solubility (>300 g/L), a log Pow <-4 and a high molecular weight. These characteristics indicate that dermal absorption will be very low and that absorption followingoral exposure will also be hampered. Moreover, the high hydrophilicity and very low octanol - water partitioncoefficient of Blue 10 25 964 do not indicate a potential for absorption in lipids. Metabolism via hydrolysis is notexpected.The substance has a MMD ca. 22 um (50% mass circa 22 um), thus indicating a certain amount of the substance to settlein the nasopharyngeal region, when exposed to dusts.Distribution and excretion:As Blue 10 25 964 is a highly water soluble product, potential for accumulation in fatty tissue can be neglected.Due to its high molecular weight elimination via bile is likely to be the main excretion mechanism.On the base of the present data, neither a conclusion on whether the substance is metabolized, nor a conclusion aboutthe distribution pattern can be drawn.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again