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EC number: 942-732-1 | CAS number: -
- 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
Description of key information
The toxicity of the carboxylic acid component of the registered substance following a repeated exposure was determined in accordance with the OECD Guideline for Testing of Chemicals 422. The NOEL and NOAEL for the test substance is defined as 400 mg/kg bw/day. The LOEL for the test substance is defined as 1600 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 23 May 2012 to 30 September 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 422. The study was conducted on 6-[(p-Tosyl)amino]hexanoic acid, which is the carboxylic acid component of the registered substance.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Daily administration by stomach tube for 54 days
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River, Germany, D-97633 Sulzfeld- Age at purchase: 11 weeks - weight rage at time of grouping: males, 175-200 g- Fasting period before study: no- Housing: 2 per cage, - Cages: TECHNIPLAST filter top cages type 2145 F with an G-Temp (PSU) durable filter cover, 480x265x210 mm³, floor area 940 cm²,- Source: Techniplast Company, Italy- Diet: ad libitum, M3, BONAGRO Ltd., reg. CZ 10174, Czech Republic- Water: ad libitum, tap water- Acclimation period: 9 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +/- 2- Humidity (%): 40 - 70- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE: Suspension in water- Amount of vehicle: 10 ml/kg- single daily administration at similar times each day
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 54 administrations, (2 weeks before mating, 2 weeks during mating and 26 days after mating)dissection ca. 24 hours after the last administration
- Frequency of treatment:
- daily
- Remarks:
- Doses / Concentrations:0, 100, 400, 1600 mg/kg body weight (mg/kg bw)Basis:actual ingested
- No. of animals per sex per dose:
- 12 males and 12 females per group including control group. 5 males and 5 females per satellite group.
- Control animals:
- yes
- Details on study design:
- - Control groups: drinking water- Dose selection rationale: Results of an acute toxicity study with oral administration to male and female rats- Result: no effects up to and including 2000 mg/kg bw.- Rationale for animal assignment: randomly grouped- Section schedule rationale: all animals were sacrificed
- Positive control:
- no
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule: dailyBODY WEIGHT: Yes - Time schedule for examinations: on administration days 1, 8, 15, 22, 29, 36, 42, 50 and on day of autopsyFOOD CONSUMPTION : 2 weeks before mating, after 2 week mating period and weekly until the end of the studyHAEMATOLOGY: Yes - Time schedule for collection of blood: day 14 (before mating) and prior to autopsy from the satellite groups and from the control and highest dose group.CLINICAL CHEMISTRY: Yes- Time schedule for collection of blood:day 14 (before mating) and prior to autopsy from the satellite groups and from the control and high dose group.URINALYSIS: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes- Organ weights: brain, heart, thymus, spleen, liver, testis, epididymis, kidney, adrenal glandHISTOPATHOLOGY: Yes: high dose and control animals- Organ: medulla oblongata, brain, heart, pancreas + lymph node, spleen, liver, lung, small intestine, stomach, kidneys, adrenal gland, testes, prostrate, urinary bladder, bone + bone marrow, thymus, trachea, white + brown fat, muscle, pituitary gland
- Statistics:
- Statistical evaluation was operated using the software SPPS version 16.0. Group data were represented by mean, standard deviation and median. Statistical analysis in case of data measured once during the study (organ weight, haematology, clinical chemistry) : Mann-Whitney U test for pairwise comparison between control and individual experimental groups on significance level alpha = 0.05.Statistical analysis in case of repeated data measurement (body weight, food intake): Repeated measures ANOVA (procedure General Linear Model (GLM) for Repeated Measures in SPSS statistical software).
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- statistically significant decrease after dosages of 1600 mg/kg bw./day
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS:- 100, 400 and 1600 mg/kg bw/day: no differences to the control animals observableMORTALITY: noBODY WEIGHT GAIN: 1600 mg/kg bw: reduced FOOD CONSUMPTION: no statistical differencesHAEMATOLOGY/ CLINICAL CHEMISTRY:Haematology and clinical chemistry reveals some statistically significant differences, but these were neither related to dosage not confirmed by the findings in other groups, for example by the results of the satellite groups, or the effects are of biological low relevance i.e..URINALYSIS: not examinedNEUROBEHAVIOUR: not examinedORGAN WEIGHTS: no statistical differencesGROSS PATHOLOGY: no dosage related effectsHISTOPATHOLOGY: NON-NEOPLASTIC: no statistical differencesHISTOPATHOLOGY: NEOPLASTIC: no statistical differencesHISTORICAL CONTROL DATA: not given
- Dose descriptor:
- NOEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decrease in body weight (not exceeding 10%)
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decrease in body weight (not exceeding 10%)
- Dose descriptor:
- LOEL
- Effect level:
- 1 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: decrease in body weight (not exceeding 10%)
- Critical effects observed:
- not specified
- Conclusions:
- Daily dosages of 0, 100, 400, and 1600 mg/kg bw of the test substance were administered by stomach tube to groups of 12 male rats for 54 days. Satellite animals in a control and the highest dose group (1600mg/kg bw) with 5 individual each were also included. The test-article was formulated in drinking water and administered in 10 ml/kg bw.At dosages of 100 and 400 mg/kg bw. the animals showed no differences to the control animals (NOAEL).1600 mg ASC plus/kg bw. , considered as the LOEC, may have induced an influence on the body weight gain of the males (and the survival of pups until day 4 after birth).NOAEL: 400 mg/kg bw.
- Executive summary:
The repeated dose toxicity of the test substance to rats was determined in accordance with the OECD Guideline for Testing of Chemicals 422. Doses of 0, 100, 400, and 1600 mg/kg bw/day of the test substance were administered by stomach tube to groups of 12 male rats for 54 days. The test-article was formulated in drinking water and administered in 10 ml/kg bw. At dosages of 100 and 400 mg/kg bw/day the animals showed no differences to the control animals (NOEL). All examined organs and tissues showed a normal histological structure. 1600 mg/kg bw/day may have induced an influence on the body weight gain of the males (and the survival of pups until day 4 after birth). The NOEL and NOAEL for the test substance is defined as 400 mg/kg bw/day. The LOEL for the test substance is defined as 1600 mg/kg bw/day.
Read-across between the carboxylic acid (6-[(p-Tosyl)amino]hexanoic acid) and the registered substance is considered justified as the registered substance is manufactured directly from 6-[(p-Tosyl)amino]hexanoic acid by simple neutralisation with 2-aminoethanol in water. In water as they are in the reaction mass, the acid and amine components of the Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) are completely dissociated and behave essentially as independent substances. Toxicity of 2-aminoethanol is local and due to its high pH value. In the reaction mass, it acts as a pH-control for the 6-[(p-Tosyl)amino]hexanoic acid, so no local toxicity is expected. No long-term systemic toxicity is expected as the substance will rapidly metabolise with NH3 and acetyl-CoA as its final degradation products. Therefore, it is considered that the acid component of the reaction mass will have a more significant impact on the outcome of any (eco)toxicological or environmental tests. The pKa of the carboxylic acid group in the reaction mass. As a result, 6-[(p-Tosyl)amino]hexanoic acid will respond to changes of pH in the same way whether it is in the salt form or as the parent carboxylic acid and hence its bioavailability will be the same. As 6-[(p-tosyl)amino]hexanoic acid, the registered substance is not considered to be toxic following a repeated exposure and does not need to be classified as such according to EU CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 400 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The repeated dose toxicity of the test substance to rats was determined in accordance with the OECD Guideline for Testing of Chemicals 422. Doses of 0, 100, 400, and 1600 mg/kg bw/day of the test substance were administered by stomach tube to groups of 12 male rats for 54 days. The test-article was formulated in drinking water and administered in 10 ml/kg bw. At dosages of 100 and 400 mg/kg bw/day the animals showed no differences to the control animals (NOEL). All examined organs and tissues showed a normal histological structure. 1600 mg/kg bw/day may have induced an influence on the body weight gain of the males (and the survival of pups until day 4 after birth). The NOEL and NOAEL for the test substance is defined as 400 mg/kg bw/day. The LOEL for the test substance is defined as 1600 mg/kg bw/day.
Read-across between the carboxylic acid (6-[(p-Tosyl)amino]hexanoic acid) and the registered substance is considered justified as the registered substance is manufactured directly from 6-[(p-Tosyl)amino]hexanoic acid by simple neutralisation with 2-aminoethanol in water. In water as they are in the reaction mass, the acid and amine components of the Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) are completely dissociated and behave essentially as independent substances. Toxicity of 2-aminoethanol is local and due to its high pH value. In the reaction mass, it acts as a pH-control for the 6-[(p-Tosyl)amino]hexanoic acid, so no local toxicity is expected. No long-term systemic toxicity is expected as the substance will rapidly metabolise with NH3 and acetyl-CoA as its final degradation products. Therefore, it is considered that the acid component of the reaction mass will have a more significant impact on the outcome of any (eco)toxicological or environmental tests. The pKa of the carboxylic acid group in the reaction mass. As a result, 6-[(p-Tosyl)amino]hexanoic acid will respond to changes of pH in the same way whether it is in the salt form or as the parent carboxylic acid and hence its bioavailability will be the same.
As 6-[(p-Tosyl)amino]hexanoic acid is not considered toxic via repeated oral exposure, the registered substance does not need to be classified as such according to EU CLP criteria.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Study was conducted by a GLP accredited laboratory using OECD Testing Guideline 422. The study was conducted on 6-[(p-Tosyl)amino]hexanoic acid, which is the carboxylic acid component of the registered substance. The NOEL and NOAEL for the test substance is defined as 400 mg/kg bw/day. The LOEL for the test substance is defined as 1600 mg/kg bw/day.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
In accordance with REACH, Annex XI, no testing is required as no significant inhalation exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
In accordance with REACH, Annex XI, no testing is required as no significant dermal exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
In accordance with REACH, Annex XI, no testing is required as no significant dermal exposure is expected in all scenarios of the manufacture and all identified uses. The substance is only associated with industrial uses and is handled by professional users with protective equipment in controlled conditions. Moreover, the substance will only be used in diluted form.
Justification for classification or non-classification
Read-across between the carboxylic acid (6-[(p-Tosyl)amino]hexanoic acid) and the registered substance is considered justified as the registered substance is manufactured directly from 6-[(p-Tosyl)amino]hexanoic acid by simple neutralisation with 2-aminoethanol in water. In water as they are in the reaction mass, the acid and amine components of the Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) are completely dissociated and behave essentially as independent substances. Toxicity of 2-aminoethanol is local and due to its high pH value. In the reaction mass, it acts as a pH-control for the 6-[(p-Tosyl)amino]hexanoic acid, so no local toxicity is expected. No long-term systemic toxicity is expected as the substance will rapidly metabolise with NH3 and acetyl-CoA as its final degradation products. Therefore, it is considered that the acid component of the reaction mass will have a more significant impact on the outcome of any (eco)toxicological or environmental tests. The pKa of the carboxylic acid group in the reaction mass. As a result, 6-[(p-Tosyl)amino]hexanoic acid will respond to changes of pH in the same way whether it is in the salt form or as the parent carboxylic acid and hence its bioavailability will be the same.
As 6-[(p-Tosyl)amino]hexanoic acid is not considered toxic via repeated oral exposure, the registered substance does not need to be classified as such according to EU CLP criteria.
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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