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Diss Factsheets
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EC number: 202-050-0 | CAS number: 91-21-4
- 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
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- repeated dose toxicity: other route
- Remarks:
- other: short-term (4-day treatment period)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline study, available as unpublished report, restrictions in reporting (available report is a summary) but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
- Principles of method if other than guideline:
- Male mice were treated intraperitoneally with 1,2,3,4-Tetrahydroisoquinoline on 4 consecutive days at three different dose levels (10 mice/dose). A concurrent control group of the same size was treated similarly with the vehicle (physioligical saline) only. Hereafter, the animals were kept for a 9-day treatment-free observation period. Endpoints to assess toxicity included clinical observations, body weight, food consumption, motor activity, brain weight, necropsy and microscopic examination of the brain.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 1,2,3,4-tetrahydroisoquinoline
- EC Number:
- 202-050-0
- EC Name:
- 1,2,3,4-tetrahydroisoquinoline
- Cas Number:
- 91-21-4
- Molecular formula:
- C9H11N
- IUPAC Name:
- 1,2,3,4-tetrahydroisoquinoline
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): 1,2,3,4-Tetrahydroisoquinoline
- Stability of the test material in 0.9% saline solution at room temperature for a period of 5 days was demonstrated before the study (01Y0797/058062). No homogeneity and concentration control analyses in the carrier was carried out in this study.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: C57BL/6 J Rj
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: 0.9% saline solution
- Details on exposure:
- 1,2,3,4-Tetrahydroisoquinoline was administered to groups of 10 male C57BL/6 J Rj mice via intraperitoneal application at dose levels of 0, 3, 50 and 200 mg/kg bw/d for 4 days followed by 9 days treatment-free observation period. The daily dosage was divided in two applications. One application was in the early morning, the second was in the afternoon.
Due to severe clinical findings the dose level in test group 3 was changed from 200 mg/kg bw/d to 100 mg/kg bw/d after the first administration on study day 0. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 days
- Frequency of treatment:
- daily dose was divided in two applications
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 3, 50 and 200 mg/kg bw/day (highest dose was reduced from 200 to 100 mg/kg bw/day after the first application)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: at least once daily
BODY WEIGHT: on days 0, 3 and 12.
FOOD CONSUMPTION: over 1-day periods on days 3 and 12.
MOTOR ACTIVITY: on days -1, 3 and 12 (12 time blocks) - Sacrifice and pathology:
- Animals which died intercurrently and those that were sacrificed moribund were disposed of without any pathological examinations.
The first 5 surviving animals per test group were subjected to deep anesthesia with isoflurane and sacrificed by perfusion fixation.
The remaining 5 animals per test group were sacrificed by decapitation under isoflurane anesthesia. The exsanguinated animals were necropsied and the brains were removed, weighed and processed for microscopic examination (HE stained slides and neuronal cell count on tyrosine hydroxylase immunohistochemical stained slides).
The corpus striatum was dissected, shock-frozen with liquid nitrogen and stored at -70°C for further examination.
Results and discussion
Results of examinations
- Details on results:
- MORTALITY
In test group 3 (200 and 100 mg/kg bw/d) 3 animals were found dead, i.e. on day 0 one animal after the second treatment, on day 1 one animal before the second treatment, and on day 3 one animal after the second treatment.
CLINICAL SIGNS
- In test group 3 (200 and 100 mg/kg bw/d) severe signs of general toxicity were observed, i.e. all animals showed high stepping gait until the end of the administration period, 9 animals showed reduced attention until the end of the administration period, 7 animals had an unsteady gait until the end of the administration period, 4 animals had tremors after the first application on day 1, 3 animals showed moderate tonic-clonic convulsions after the first application on day 0, 2 animals with poor general condition (one animal on day 1 after the first application and one animal from day 7 onwards), one animal showed salivation after the first application on day 0, and one animal showed piloerection from day 7 onwards.
- In test group 2 (50 mg/kg bw/d) 5 animals showed reduced attention until the end of study day 1.
- In test group 1 (3 mg/kg bw/d) no test substance-related, adverse findings were observed.
BODY WEIGHT AND WEIGHT GAIN
On day 3 body weight loss of 5% was observed for animals of test group 3 (200 and 100 mg/kg bw/d). Body weight change values were also significantly decreased in this group on study day 3 (-271%).
FOOD CONSUMPTION
No test substance-related findings were observed.
MOTOR ACTIVITY
In test group 1 (3 mg/kg bw/d) the single interval 9 on study day 3 was significantly decreased. On study day 12 the single intervals 8, 9 and 12 were significantly decreased in test group 2 (50 mg/kg bw/d). These findings were assessed as being incidental and not test substance-related as no dose-response relationship was observed.
BRAIN WEIGHT
The mean absolute and relative weights of treated animals did not show relevant differences compared to the control group.
GROSS PATHOLOGY
No gross lesions were observed in all test animals.
HISTOPATHOLOGY OF THE BRAIN
The light microscopic examination of HE-stained slides as well as the neuronal cell count on tyrosine hydroxylase immunohistochemical stained slides revealed no differences between control animals and treated animals of test group 3.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Based on clinical signs of toxicity (from 50 mg/kg bw/day) and reduced body weight (at 200/100 mg/kg bw/day)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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