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EC number: 225-896-2 | CAS number: 5137-55-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Toxicity to reproduction
No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to be above 25-100mg/kg/day, When male and female rats were treated with Methyltrioctylammonium chloride (5137-55-3) orally. Thus, based on the avaliable experimental study of structurally similar read across substance No Observed Adverse Effect Level (NOAEL) was considered to be above 25 -100mg/kg bw . Thus, comparing this value with the criteria of CLP regulation Methyltrioctylammonium chloride (5137-55-3) cannot be classified as reproductive toxicant.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is Klimicsh 2 and from authoritative database
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity
Data available for the read across chemicals was reviewed to determine the reproductive toxicity of Methyltrioctylammonium chloride (5137-55-3). The studies are as mentioned below:
Study 1
Two generation reproduction study of test material was performed on male and female Sprague Dawley CD® rats in accordance with OECD guideline 416 (1983). Although oestrus cycle, sperm parameters and sexual maturation of pups was not investigated, no reproductive effects were observed indicating indirectly no effect on these parameters. The study is considered acceptable. The test material mixed with food in dose concentration 0, 20, 50 and 100 mg /kg bw/day (0, 300, 750 and 1500 mg/kg food ).28 male and 28 female placed in each dose group. Diet starting 10 weeks before mating (F0) or at weaning (F1), throughout mating, gestation and lactation periods until scheduled necropsy. F0 rats were mated twice to produce F1a and F1b litters. Twenty-eight parents/sex of the F2 generation were selected from the F1b litters. They were mated twice to produce F2a and F2b litters. Mating was allowed for up to 21 days. Necropsy was performed on 10 pups/sex/dose from the F1a and F1b generation. Clinical signs, mortality, body weight and Food consumption were noted in each generation. No treatment-related clinical signs were observed. There were no treatment related deaths during the study. One male at each dosing level was killed due to trauma or caging accident or sacrificed moribund. Body weight gain was reduced in males and females at 100 mg/kg/day food during the premating period. Food consumption was reduced at 100 mg/kg /day during the premating period in males and females. At necropsy no treatment-related abnormalities were observed, including histopathological examinations there were no changes detected between parental animals of the treated and control groups in mating indices and pregnancy rates. No treatment-related changes were detected in litter size, live birth index, viability index, lactation index and sex ratio of the F0 offspring. F1 pup weight gains were initially similar to those in the control group, but were significantly decreased on day 21 and 28 post-partum at 100 mg/kg /day (82-87% and 83-86% of control for F1a males and females, and 76-85% and 78-83% of control for F1b males and females, resp.). F1a and F1b pups showed no treatment-related macroscopic findings. F1 parental animals showed no treatment-related mortality or clinical signs. Body weight gain was only incidentally reduced for F1 parents. Body weights of males and females at 100 mg/kg /day were already significantly reduced at the beginning of mating due to the reduced body weight gain during their lactation period. Body weights of females were still decreased during gestation and were equal to controls at the end of lactation due 10 increased body weight gains relative to controls during gestation and lactation (F28 and F2b). Food consumption was significantly reduced at 100mg/kg /day in F1 males until week 7 and F1 females during the whole pre-mating period. No changes were noted between parental animals of the treated and control groups in mating indices, pregnancy rates and male fertility. At necropsy no treatment-related abnormalities were observed, including histopathological examination. No treatment-related changes were observed in litter size, live birth index, viability index,l actation index or sex ratio of the F, offspring (F2pups). F2apup weight gains were decreased at 100 mg/kg /day on day 21 and 28 post-partum (85-89% and 83-90% of control for males and female resp.). F2bpup weight gains were decreased at 100 mg/kg/day on day 21 and 28post-partum (85-89%and 84-86% of control).F2a andF2b pups showed no treatment- related macroscopic finding. Hence No Observed Adverse Effect Level (NOAEL) for F0 generation was considered to be 100mg/kg/day, As No treatment related changes were noted in mating behaviour, conception and gestation and the NOAEL for developmental toxicity was considered to be 50 mg/kg /day, based on decreased body weight. When female Sprague Dawley rats were treated with test material orally.
Study 2
Reproductive and development toxicity study oftest material was performed on femalewistar rats.20-22 rats /dose group were used. The test materialwas administered in dose concentration 0, 8, 25,50 mg/kg bw/day from day 5 through day 14 of gestation by gastric intubation route. All of the dams were killed on day 20 of gestation and Uterine contents examined. The foetuses were weighed, sexed and subjected to external, soft tissue or skeletal examinations.The incidence of resorption site was increased in the dams from the 50 mg/kg bw dose group. Fetal survival was reduced in 50 mg/kg bw dose group. No evidence of adverse effects on litter size , viability ot litter weight in any dose group.There were no treatment-related malformations or variations in any groups at external, soft tissue or skeletal examinations. Hence No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to be 25 mg/kg/day, and the dose-level of 50 mg/kg/day was considered to be the NOAEL for embryo-foetal toxicity.When femalewistar rats were treated withtest material orally.
Thus, based on the avaliable experimental study of structurally similar read across substance No Observed Adverse Effect Level (NOAEL) was considered to be above 25 -100mg/kg bw. Thus, comparing this value with the criteria of CLP regulation Methyltrioctylammonium chloride (5137-55-3) cannot be classified as reproductive toxicant.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus, comparing this value with the criteria of CLP regulation Methyltrioctylammonium chloride (5137-55-3) cannot be classified as reproductive toxicant.
If however the content of CAS # 68814-95 -9 (Repro Cat. 1B, Fertility and Development) is at or greater than 0.3 % (but less than 10 %), a classification with Repro Cat. 1B (F, D) is warranted.
Additional information
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