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EC number: 203-916-0 | CAS number: 111-86-4
- 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
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2005-10-12 through 2007-07-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, but as read-across from supporting substance maximum reliability is 2. Read-across hypothesis: for details please see read-across report in IUCLID section 13.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD (SD) IGS
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 14 days
- Proof of pregnancy: sperm in vaginal smear; referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged (how): singly - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males 47-48 days; females 42-46 days
- Frequency of treatment:
- daily
- Details on study schedule:
- - Age at mating of the mated animals in the study: 13 weeks
- Remarks:
- Doses / Concentrations:
0, 37.5, 75, 100/150 mg/kg bw/day
Basis:
analytical conc. - No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects on clinical signs; mortality; body weight live birth index; litter size; pup weight; sex ratio; survival index;
- Reproductive effects observed:
- not specified
- Conclusions:
- There were no signs of toxicity to reproduction seen in parental animals or offspring in a valid OECD TG 422 oral gavage screening study using rats up to and including 100 mg octylamine hydrochloride/kg bw/day. The NOAEL for reproduction toxicity was therefore 100 mg/kg bw/day.
- Executive summary:
Octylamine-HCl was examined for its potential for repeated toxicity, developmental and neurotoxicity in a combined OECD TG 422 study under GLP conditions. The dose levels used (0, 37.5, 75, an 100/150 mg/kg bw/day; oral gavage; 12 rats/sex/dose) were selected based on the results of two range finding studies, one in the range 100-1000 mg/kg bw/day, and one in the range 3-100 mg/kg bw/day. The high dose group was initially dosed at 150 mg/kg bw/day, but this was lowered 100 mg/kg bw/day by test day 14 because two mortalities were seen in this group. Therefore, this dose level is called “100/150 mg/kg bw/day”. It should however be mentioned that subsequent examinations revealed that these mortalities resulted from maldosing and were not related to the test substance.
The parameters examined in parental animals (gestation length, reproductive function indices [mating index, fertility index, gestation index, implantation efficiency], and corpora lutea counts] and in the offspring (viability at birth and on post partum day 4, sex ratio, weight at birth and on post partum day 4, clinical signs) were comparable across all groups including the control group. The NOAEL for reproduction toxicity was therefore 100 mg/kg bw/day under the conditions of this study.
Overall, there were no signs of toxicity to reproduction seen in parental rats or offspring in a valid OECD TG 422 oral gavage screening study receiving
octylamine hydrochloride up to and including 100 mg/kg bw/day (DuPont, 2007).
Reference
Read-across hypothesis: for details please see read-across report in IUCLID section 13.
.There was no statistically significant change in any of the dose groups compared to the control group in any of the parameters examined in the parental animals or in the offspring. Detail infromation is contained in the attached document.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- reliable guideline study with RA substance octylamine-HCl
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Octylamine-HCl was examined for its potential for repeated toxicity, developmental and neurotoxicity in a combined OECD TG 422 study under GLP conditions. The dose levels used (0, 37.5, 75, an 100/150 mg/kg bw/day; oral gavage; 12 rats/sex/dose) were selected based on the results of two range finding studies, one in the range 100-1000 mg/kg bw/day, and one in the range 3-100 mg/kg bw/day. The high dose group was initially dosed at 150 mg/kg bw/day, but this was lowered 100 mg/kg bw/day by test day 14 because two mortalities were seen in this group. Therefore, this dose level is called “100/150 mg/kg bw/day”. It should however be mentioned that subsequent examinations revealed that these mortalities resulted from maldosing and were not related to the test substance.
The parameters examined in parental animals (gestation length, reproductive function indices [mating index, fertility index, gestation index, implantation efficiency], and corpora lutea counts] and in the offspring (viability at birth and on post partum day 4, sex ratio, weight at birth and on post partum day 4, clinical signs) were comparable across all groups including the control group. The NOAEL for reproduction toxicity was therefore 100 mg/kg bw/day under the conditions of this study.
Overall, there were no signs of toxicity to reproduction seen in parental rats or offspring in a valid OECD TG 422 oral gavage screening study receiving
octylamine hydrochloride up to and including 100 mg/kg bw/day (DuPont, 2007).Short description of key information:
No toxicity to reproduction was seen in parental rats or offspring in a valid OECD TG 422 oral gavage GLP screening study receiving
octylamine hydrochloride up to and including 100 mg/kg bw/day (DuPont, 2007).
Justification for selection of Effect on fertility via oral route:
only study available
Effects on developmental toxicity
Description of key information
No toxicity to reproduction was seen in parental rats or offspring in a valid OECD TG 422 oral gavage GLP screening study receiving
octylamine hydrochloride up to and including 100 mg/kg bw/day (DuPont, 2007).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- reliable guideline study with RA substance octylamine-HCl
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Octylamine-HCl was examined for its potential for repeated toxicity, developmental and neurotoxicity in a combined OECD TG 422 study under GLP conditions. The dose levels used (0, 37.5, 75, an 100/150 mg/kg bw/day; oral gavage; 12 rats/sex/dose) were selected based on the results of two range finding studies, one in the range 100-1000 mg/kg bw/day, and one in the range 3-100 mg/kg bw/day. The high dose group was initially dosed at 150 mg/kg bw/day, but this was lowered 100 mg/kg bw/day by test day 14 because two mortalities were seen in this group. Therefore, this dose level is called “100/150 mg/kg bw/day”. It should however be mentioned that subsequent examinations revealed that these mortalities resulted from maldosing and were not related to the test substance.
The parameters examined in parental animals (gestation length, reproductive function indices [mating index, fertility index, gestation index, implantation efficiency], and corpora lutea counts] and in the offspring (viability at birth and on post partum day 4, sex ratio, weight at birth and on post partum day 4, clinical signs) were comparable across all groups including the control group. The NOAEL for reproduction toxicity was therefore 100 mg/kg bw/day under the conditions of this study.
Overall, there were no signs of toxicity to reproduction seen in parental rats or offspring in a valid OECD TG 422 oral gavage screening study receiving
octylamine hydrochloride up to and including 100 mg/kg bw/day (DuPont, 2007).Justification for selection of Effect on developmental toxicity: via oral route:
only study available
Justification for classification or non-classification
A reproductive and developmental NOAEL of 100 mg/kg bw/day (highest dose tested), determined in a combined repeated dose toxicity study with a reproduction/developmental toxicity screening test (OECD test guideline 422), indicates that no classification is required under Regulation (EC) No 1272/2008. There is no evidence of n-octylamine hydrochloride inducing adverse effects on parental fertility or development of offspring.
Additional information
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.
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