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EC number: 943-304-7 | CAS number: -
Reactive Blue 50 is considered to have a NOAEL of 1000 mg/kg bw/day on repeated exposure.
The study was conducted to assess the possible effects of FAT 20033/L at the dose level of 100, 300 and 1000 mg/kg repeated dose administration to male and female Wistar rats according to OECD 422 guideline. The test item was administered daily in graduated doses to 3 groups of test animals, one dose level per group for a treatment period of 54 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 3 in females. Males were dosed after the mating period until the minimum total dosing period of 28 or 29 days were completed. Animals of an additional control group were handled identically as the dose groups but received aqua ad injectionem, the vehicle used in this study. The 4 groups comprised 10 male and 10 female Wistar rats.
The following doses were evaluated:
Control (C): 0 mg/kg/d
Low Dose (LD): 100 mg/kg/d
Medium Dose (MD): 300 mg/kg/d
High Dose (HD): 1000 mg/kg/d
The test item formulation was once in every ten days and stored at 2-8 °C. The administration volume was 5 mL/kg body weight. During the period of administration, the animals were observed each day for signs of toxicity. At the conclusion of the test, surviving animals were sacrificed and observed macroscopically. Body weight and food consumption were measured weekly. Functional observations including sensory reactivity to different stimuli, grip strength, motor activity assessments and other behavior observations were performed in the week before the treatment and at the end of the study. Haematological, clinical biochemistry and urine analysis evaluations were performed on blood samples collected at terminal sacrifice from five males and five randomly selected lactating females from each group. A full histopathological evaluation of the tissues was performed of 5 randomly selected male and female animals of the control and high dose groups. Gross lesions from all groups were examined by light microscopy. No treatment related adverse effects were found in any of the dose group.No gross lesions were observed in this study those could be attributed to treatment with the test item. All gross lesions were within the range of normal background alterations which may be recorded in animals of this strain and age, or were considered to be incidental macroscopic findings that did not correlate with microscopic changes. There were no adverse toxicological effects in the adult males and females at any administered dose. Thus, the no observed adverse effect level (NOAEL) of FAT 20033/L is considered to be 1000 mg/kg/d for systemic toxicity in males and females.
Data on repeated dose toxicity are not available for the target substance i.e FAT 40069. To fill the data gaps, read across approach is adapted using similar substance FAT 20033/L. Read-across is claimed basis of structural relationship of the target and the source chemicals. Read-across substance is FAT 20033/L and have been investigated for repeat dose toxicity.
Based on this toxicity screening test with FAT 20033/L in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg/d conducted according to OECD 422 guideline (GLP compliant), there were no adverse toxicological effects in the males and females observed at any administered dose level. Thus, the no observed adverse effect level (NOAEL) of FAT 20033/L is considered to be 1000 mg/kg/d for systemic toxicity in males and females.
Currently no study to assess the repeated dose inhalation toxicity potential of Reactive Blue 050 is available. However, the vapour pressure for the substance can be considered low owing to the high melting point (>320 °C). Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further, the chemical is found to have water solubility of 257 g/L, hence, in the case of dust of the substance entering the respiratory tract, it will be trapped in the mucus and cleared, thereby further limiting the absorption. No systemic toxicity was observed when the source substance, Acid Blue 277, was administered up to 1000 mg/kg bw/day via gavage in a combined repeated dose toxicity study with reproductive/developmental toxicity screening. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon inhalation exposure and not after systemic application. Taking into consideration the above arguments, low toxicity potential is expected on repeated exposure of Reactive Blue 050 via inhalation route and safety for human health can be estimated using the principles of read across and route to route extrapolation. Hence, the conduct of repeated dose toxicity study via inhalation route for Reactive Blue 050 is considered to be scientifically not necessary.
Currently no study to assess the repeated dose dermal toxicity of Reactive Blue 050 is available. However, the molecular weight of the chemical is 773.93 g/mol , indicating it being too large for dermal absorption. It has water solubility of 257 g/L and n-octanol/water partition coefficient (log P) of -3.51, indicating it being too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance will be low. No systemic toxicity was observed when the source substance Acid Blue 277 was administered upto 1000 mg/kg bw/day via gavage in a combined repeated dose toxicity study with reproductive/developmental toxicity screening. Similarly, absence of systemic toxicity in skin irritation and sensitisation studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Taking above arguments into account, low toxicity potential is expected on repeated exposure via dermal route and safety for human health can be estimated using the principles of read across and route to route extrapolation. Hence, the conduct of repeated dose toxicity study via dermal route for Reactive Blue 050 is considered to be scientifically not necessary.
Based on the findings of the repeated dose toxicity study, the test substance does not meet the criteria of the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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