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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
Endpoint summary
Administrative data
Description of key information
Skin irritation (in vivo, OECD 404): not irritating
Eye irritation (in vivo, OECD 405): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-12-01 to 1992-12-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 12 May, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Comission Directive No. 84/449/EEC
- Version / remarks:
- adopted 25 April, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, Halle, Germany
- Age at study initiation: 8 - 12 months
- Weight at study initiation: 2.31 - 2.46 kg
- Housing:individually in stainless steel cages with grating floor
- Diet: standard diet: ssniff K, special diet for rabbits; approx. 120 g/day/animal
- Water: drinking water, ad libitum
- Acclimation period: 1 day under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.5
- Humidity (%): 55 - 70
- Photoperiod: 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g test item glycyl-L-glutamine monohydrate, equivalent to 0.46 g anhydrous glycyl-L-glutamine, moistened with 0.25 mL water
VEHICLE
- Amount(s) applied: 0.25 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left site of the vertebral column (dorsal skin area between shoulder and sacrum), 6.25 cm2
- Type of wrap if used: The site of application was covered with a patch consisting of two layers: a cellulose fabric coated with natural rubber and a synthetic film glue. A bandage wrapped several times around the trunk provided a complete occlusion.
REMOVAL OF TEST SUBSTANCE
- Washing: After the end of the exposure period remaining test material was gently washed off as far as possible.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reversibility not applicable
- Irritant / corrosive response data:
- No local reactions indicative for skin irritation were observed at any time point in any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the test, the test item is not irritating to the skin.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-12-08 to 1992-12-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Comission Directive No. 84/449/EEC
- Version / remarks:
- adopted 25 April, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, Halle, Germany
- Age at study initiation: 8 - 9 months
- Weight at study initiation: 2.54 - 3.02 kg
- Housing: individually in stainless cages with grating floor, type ASTA, size 48.5 x 40 x 36.5 cm
- Diet: approx. 120 g/day / animal standard diet (ssniff K, special diet for rabbits)
- Water: drinking water, ad libitum
- Acclimation period: at least one day under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.5
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 39.7 - 44.1 mg test item glycyl-L-glutamine monohydrate, equivalent to 36.5 - 40.6 anhydrous glycyl-L-glutamine (representing a volume of about 0.1 mL) - Duration of treatment / exposure:
- Single exposure, no washing
- Observation period (in vivo):
- Reading time points: 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Cliptrix pencil light - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- During the observation period the only eye lesion observed was a slight discharge (grade 1) detected in one animal at 48 h after application. The effect was fully reversible within 72 h.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Glycyl-L-glutamine is not irritating to the eye.
CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
To assess the potential of the test material to cause skin irritation/corrosion an acute dermal irritation / corrosion study was performed in accordance with OECD guideline 404 and in compliance with GLP (92-0044-DNT). 0.5 g test item glycyl-L-glutamine monohydrate, equivalent to 0.46 g anhydrous glycyl-L-glutamine, was moistened in water and applied to the dorsal skin of 3 White Russian rabbits between shoulder and sacrum for 4 h under occlusive conditions. The adjacent area of the dorsal skin was treated in the same manner but without test substance (control site). Local skin reactions (erythema and edema) were evaluated according to the Draize scoring system, 1, 24, 48 and 72 h post-application.
There were no local skin reactions at any time point in any animal. The mean scores for the 3 animals over 24/48/72 h was 0 for erythema and oedema, respectively. Based on the results of the present study and under the experimental conditions mentioned, the test item is not considered to be irritating to the skin.
Eye irritation/corrosion
The eye irritating potential of the test item was evaluated in an acute eye irritation/corrosion in vivo study according to OECD guideline 405 and in compliance with GLP (92-0045-DNT). Three White Russian rabbits received a single test item dose of 39.7 - 44.1 mg test item glycyl-L-glutamine monohydrate, equivalent to 36.5 - 40.6 anhydrous glycyl-L-glutamine (corresponding to 0.1 mL) instilled into the conjunctival sack of the left or the right eye. The eye was not washed following installation. The other eye remained untreated and served as control.
The local irritation effects on the eyes were scored according to Draize criteria 1, 24, 48 and 72 h post instillation.
During the observation period, the only eye lesion observed was a slight discharge (grade 1) which was detected in 1/3 rabbits 48 h after test substance instillation. The effect was fully reversible within 72 h. There were no other indication of eye irritation observed. The mean scores for the 3 animals over 24/48/72 h was 0 for all the irritation parameters measured (cornea, iris, conjunctivae and chemosis, respectively).
Based on these results and under the experimental conditions of the present study, the test item is not considered to be irritating to the eye.
Justification for classification or non-classification
The available data on skin and eye irritation do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.
No classification for skin or eye irritation / corrosion is warranted according to the criteria of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations.
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