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EC number: 200-795-6 | CAS number: 73-22-3
- 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
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-11-27 to 2007-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 423 (adopted 2001)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Strain: Hsd:Sprague-Dawley SD
Source: Harlan Italy S.r.l.
Body weight: 176 – 200 g
Age: ca. 6 - 8 weeks
Acclimatisation period: at least 5 days
Housing: in groups of 3, polycarbonate cages, equipped with a stainless steel mesh lid and floor
Diet: laboratory rodent diet (4 RF 18) ad libitum throughout the study except for an overnight fast prior to dosing and a period of approximately 4 hours after dosing
Water: ad libitum
Environmental conditions
Temperature (°C): 22 ± 2
Relative humidity (%): 55 ± 15
Photoperiod (hrs dark / hrs light): 12 / 12 by fluorescent tubes
Air changes (per hr): 15-20 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- The test item was formulated for dosing by suspension in 0.5% aqueous solution of carboxymethylcellulose to give a concentration of 200 mg/mL.
Dose volume: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Two groups with 3 females each were tested
- Control animals:
- no
- Details on study design:
- Animals were fasted overnight prior to dosing and food was made available approximately 4 hours after dosing.
Mortality and morbidity: Throughout the study all animals were checked twice daily.
Clinical signs: Animals were observed for clinical signs immediately upon dosing, approximately 30 min, 2 and 4 hours after dosing and daily thereafter for a total of 14 days.
Body weight: All animals were weighed at allocation to the study (day -1), immediately prior to dosing (day 1) and on days 2, 8 and 15.
All animals were killed on day 15 and were subjected to a gross necropsy examination for both external and internal abnormalities. The cranial, thoracic and abdominal cavities were opened to allow examination of their contents. Larger organs were sectioned. Both the stomach and representative sections of the gastro-intestinal tract were opened for examination of the mucosal surfaces. - Statistics:
- not further specified
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: In trial 1, clinical signs were limited to piloerection seen on the day of dosing at the 2 and 4 hour post-dose observations. In trial 2, piloerection, hunched posture and reduced activity were observed in the animals on the day of dosing. Complete recove
- Gross pathology:
- No abnormalities found at termination
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity of L-tryptophan feed grade was investigated in a GLP study according to OECD guideline 423. Two groups of 3 female Sprague-Dawley rats were dosed with 2000 mg/kg bw and observed for a period of 14 days. No mortality occurred. In trial 1, clinical signs were limited to piloerection seen on the day of dosing at the 2 and 4 hour post-dose observations. In trial 2, piloerection, hunched posture and reduced activity were observed in the animals on the day of dosing. Complete recovery occurred by day 2. Changes in body weight were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination at termination of the study. From this study a LD50 value of > 2000 mg/kg bw can be derived.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- LD50 value: > 2000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-03-12 to 2008-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline 403 (adopted 1981)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- traditional inhalation LC50 study
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Charles River Deutschland GmbH, Sulzfeld, Germany
Age at study initiation: 8 – 9 weeks at time of administration
Body weight: 229 - 322 g before exposure
Housing: single caging in Makrolon type III cages; wire mesh lids
Diet: Ssniff R/M-H maintenance diet ad libitum
Water: tap water, ad libitum
Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
Temperature (°C): 21.7-24.3
Humidity (%): 46.2-64.9
Air changes (per hr): 12
Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Exposure apparatus: exposure chamber from TSE, Technical & Scientific Equipment GmbH, Germany
Exposure chamber volume: 19 L
System of dust generating: dust generator Technical & Scientific Equipment GmbH, Germany
Method of particle size determination: cascade impactor
Rate of air: 700 L/h
MMAD: 3.1 um - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Measurement by gravimetric analysis. Dust was collected 12 times during exposure period. The exact amount of collected air was measured by a gas meter.
- Duration of exposure:
- 4 h
- Concentrations:
- Target concentration: 5 mg/L
Actual concentration of the dust: 5.17 mg/L - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Frequency of observations: 1 - 6 hours after the start of exposure and daily thereafter
Frequency of weighing: day 0 and on days 7 and 14 following administration
Necropsy of survivors performed: yes
Other examinations performed: clinical signs, body weight - Statistics:
- Means and standard deviations of each test group were calculated for body weight and body weight gain. Median was calculated for environmental condition in the animal room. The particle size distribution was statistically evaluated based on probit analysis. As a limit test was performed, no calculation of the LC50 was possible.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.17 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- No mortality.
- Clinical signs:
- other: All animals were normal during the whole 14-day observation period
- Body weight:
- Mean body weights: Prior to study: 322 g (males) and 229 g (females); End of study: 407 g (males) and 252 g (females)
Mean weight gain: days 0-7: 38.4 g (males) and 5.4 g (females); days 7-14: 45.8 g (males) and 18.0 g (females)
Two females lost weight in the first week after exposure - Gross pathology:
- Nothing abnormal was seen in any of the animals
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- L-tryptophan feed grade was tested in a GLP study according to OECD guideline 403. The 4h-inhalation exposure of male and female Sprague-Dawley rats at a concentration of 5.17 mg/L gave no indications for adverse effects. Therefore, the 4h-LC50 is greater than 5.17 mg/L air.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 170 mg/m³ air
- Quality of whole database:
- LC50 value: > 5170 mg/m3
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity of L-tryptophan was investigated in a GLP study according to OECD guideline 423. Two groups of 3 female Sprague-Dawley rats were dosed with 2000 mg/kg bw and observed for a period of 14 days. No mortality occurred. In trial 1, clinical signs were limited to piloerection seen on the day of dosing at the 2 and 4 hour post-dose observations. In trial 2, piloerection, hunched posture and reduced activity were observed in the animals on the day of dosing. Complete recovery occurred by day 2. Changes in body weight were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination at termination of the study. From this study a LD50 value of > 2000 mg/kg bw can be derived.
L-tryptophan feed grade was tested in a GLP study according to OECD guideline 403. The 4h-inhalation exposure of male and female Sprague-Dawley rats at a concentration of 5.17 mg/L gave no indications for adverse effects. Therefore, the 4h-LC50 is greater than 5.17 mg/L air.
Justification for classification or non-classification
Due to the effect levels obtained in the acute toxicity studies, no classification according to EU and GHS criteria is required.
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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