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EC number: 309-913-1 | CAS number: 101357-16-8
- 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
Key study: OECD 422. GLP study: The NOEL/NOAEL were 1000 mg/kg bw/day in rats (no effects observed at highest dose).
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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method according to OECD Guideline 422. GLP study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation: 10 weeks old
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methylcellulose aqueous solution (suspended)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg
- 0.5% w/v methylcellulose aqueous solution (suspended) - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males: 42 days (from 14 days before mating, and through the mating period until a day before necropsy).
Females: 41-48 days (from 14 days before mating, and through the mating period until day 4 of lactation). - Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0 (control), 40, 200, 1000 mg/kg/day
Basis:
actual ingested - No. of animals per sex per dose:
- Males: 7 (control), 12 (40 mg/kg bw/day), 12 (200 mg/Kg bw/day), 7 (1000 mg/kg bw/day), 5 (control with recovery), 5 (1000 mg/kg bw/day with recovery).
Females: 12 (control), 11 (40 mg/kg bw/day), 11 (200 mg/Kg bw/day), 12 (1000 mg/kg bw/day), 5 (control with recovery), 5 (1000 mg/kg bw/day with recovery). - Control animals:
- yes
- Details on study design:
- - Dose selection rationale: In the 14-day range finding study with 5 males and 5 females at dose levels of 0, 100, 300, 1000 mg/kg/day, there were no changes attributed to the treatment at any groups. (Inspection items: clinical signs, body weight, food consumption, necropsy, organ weight, hematology and blood chemistry).
- Post-exposure recovery period in satellite groups: 14 days. - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: End of the dosing and recovery period.
- How many animals: All animals
- Parameters checked: RBC, WBC, Hb, Plat., MCV, MCH, MCHC, Ret., Eosino., Baso., Mono., Lymph., Neutro., LUC, PT, APTT, Fibrin.,
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: End of the dosing and recovery period.
- How many animals: All animals
- Parameters checked: ASAT, ALTA, ALP, CPK, T. Bil., T. Prot., Albumin, T. Chol., TGL, PL, Glucosa, BUN, Creat., IP, Ca, Na, K, Cl, α1-glob., α2-glob., β-glob., γ-glob., A/G.
URINALYSIS: Yes (in males)
NEUROBEHAVIOURAL EXAMINATION: Yes
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all animals at the end of the dosing and recovery periods.
Absolute and relative organ weight:
Males: Adrenals, testis, thymus, spleen, brain, heart, lung, liver, kidney, epididymus, sem. vesic., prostate.
Females: Adrenals, ovaries, thymus, spleen, brain, heart, lung, liver, kidneys.
HISTOPATHOLOGY: Yes, animals within control and highest dose tested (1000 mg/kg bw/day), at the end of dosing and recovery period.
Male: Femoral bone marrow, heart, kidney, liver, lung, prostate, stomach, thyroid, trachea.
Females: Adrenal, femoral bone marrow, heart, kidney, liver, lung, spleen, stomach, thymus, thyroid, trachea, uterus, adipose tissue. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- 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:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No animal died in any test article group.
No test article-related changes were observed in clinical signs.
Only test article-colored feces were observed in all groups.
BODY WEIGHT AND WEIGHT GAIN
No test related effects were observed.
FOOD CONSUMPTION.
No test related effects were observed.
HAEMATOLOGY
No test related effects were observed.
CLINICAL CHEMISTRY
No test related effects were observed.
URINALYSIS
No test related effects were observed in males.
NEUROBEHAVIOUR
No test related effects were observed.
ORGAN WEIGHTS
No test related effects were observed.
GROSS PATHOLOGY
No test related effects were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No test related effects were observed. - Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: (no effects observed at highest dose)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: (no adverse effects observed at highest dose)
- Critical effects observed:
- not specified
- Conclusions:
- The NOEL and NOAEL for repeated dose toxicity in rats were determined to be 1000 mg/kg bw/day since no effects were observed in the highest dose tested.
- Executive summary:
A combined repeated dose toxicity study with the reproduction/developmental screening test was performed with the test item according to OECD Guideline 422 (GLP study). Based on a preliminary 14 -days range-finding study, test item was administered orally to 12 male and female rats at 0 (control), 40, 200 and 1000 mg/kg bw/day for 42 days (from 14 days before mating, and through the mating period until a day before necropsy) and for 41-48 days (from 14 days before mating, and through the mating period until day 4 of lactation) respectively. For the control and 1000 mg/kg bw/day groups, a 2 -week recovery period was set to follow the 42 -day repeated oral administration period to assess the reversibility of the toxicity. Animals were subjected to necropsy at the end of the dosing and recovery periods. No animals died in any test article group, and no test article related changes were observed in clinical signs, detailed observations, grip strength, locomotor activity, body weight, food consumption, hematology, blood chemistry, urinalysis (only perfomed in males), organ weight, necropsy, or histopathology. Based on these results, the NOEL and NOAEL for repeated dose toxicity in rats was determined to be 1000 mg/kg bw/day since no effects were observed in the highest dose tested.
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS:
NON-CONFIDENTIAL NAME OF SUBSTANCE: Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
[please address all points below]:
- Available GLP studies: Not available.
- Available non-GLP studies: Not available.
- Historical human data: Not available.
- (Q)SAR : Not available.
- In vitro methods: Not available.
- Weight of evidence: Not available.
- Grouping and read-across : Not available.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The specific adaptation possibilities of Column 2 of REACH Annex VIII are not adequate to generate the necessary information since:
- In a reliable short-term toxicity study (28 days) no adverse effects were observed which concluded a classification as STOT RE according to the CLP Regulation (EC) no. 1272/2008. Thus,no extrapolation towards the NOAEL-90 days would be allowed.
- There is no reliable chronic study available.
- There is no sufficient information on the cleavage products (both for systemic and effects at the site of updatake).
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The following study is proposed:
Test method according to OECD Guidance 408, i.e. 90 days repeated exposure by oral route, in rats. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Species:
- rat
- Critical effects observed:
- not specified
Referenceopen allclose all
See the observed effects attached.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study is GLP compliant and of high quality (Klimisch score = 1).
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
Key study: Experimental data.
Test method according to OECD 422. GLP study.
The NOEL and NOAEL for repeated dose toxicity in rats were determined to be 1000 mg/kg bw/day since no effects were observed in the highest dose tested.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available.
Justification for classification or non-classification
Based on the available information, the substance is not classified for repeated dose toxicity according to CLP Regulation (EC) No. 1272/2008.
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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