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EC number: 700-144-0 | CAS number: 13115-71-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 December 2021 - 26 January 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (2S)-2-(2-aminoacetamido)-4-carbamoylbutanoic acid
- EC Number:
- 700-144-0
- Cas Number:
- 13115-71-4
- Molecular formula:
- C7H13N3O4
- IUPAC Name:
- (2S)-2-(2-aminoacetamido)-4-carbamoylbutanoic acid
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8-10 weeks old
- Weight at study initiation: 174 to 197 g
- Fasting period before study: no
- Housing: individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized wooden fibers as bedding material equipped with water bottles.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was
provided ad libitum
- Water: Municipal tap-water was freely available to each animal via water bottles
- Method of randomisation in assigning animals to test and control groups: all animals within ± 20% of the sex mean body weights
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (target 20-24°C)
- Humidity (%): 50-60% (target 40-70%)
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 January 2022 To: 26 January 2022
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The samples were applied after moistening with 0.5. mL water (Elix), to ensure close contact to the skin.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 x 7 cm
- % coverage: 18 cm2 for females
- Type of wrap if used: surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- 2178 mg/kg bw (monohydrate form; test item; CAS 172669-64-6) equivalent to
2000 mg/kg bw (anhydrous form; CAS 13115-71-4) - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter; animals were weighed individually on Days 1 (pre-dose), 8 and 15
- Necropsy of survivors performed: yes
- Irritation: skin reactions were assessed at least once daily after removal of the dressing and test
item
Results and discussion
- Preliminary study:
- A range finding study was performed in order to select the dose causing no mortality or significant toxicity to be used in the main study. One animal was dosed at 2000 mg/kg.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 178 mg/kg bw
- Based on:
- test mat.
- Remarks:
- monohydrate form (CAS 172669-64-6; test item)
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- anhydrous form (CAS 13115-71-4)
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortality occurred.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight gain shown by two of the animals during the observation period was within the range expected for rats used in this type of study. The lack of body weight gain between Days 1 and 15 in one animal was considered not indicative of toxicity, based on the absence of any corroborative findings in these animals.
- Gross pathology:
- No abnormalities were found at macroscopic postmortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Based on these results, Glycyl-L-Glutamine monohydrate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
- Conclusions:
- The dermal LD50 value of Glycyl-L-Glutamine monohydrate (CAS 172669-64-6) in Wistar Han rats was established to exceed 2178 mg/kg body weight, equivalent to 2000 mg/kg body weight of the anhydrous form Glycyl-L-Glutamine (CAS 13115-71-4).
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