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EC number: 200-273-8 | CAS number: 56-41-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1993-04-23 to 1993-06-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, used for read-across
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- L-tert-Leucine
- IUPAC Name:
- L-tert-Leucine
- Reference substance name:
- 20859-02-3
- EC Number:
- 606-659-6
- Cas Number:
- 20859-02-3
- IUPAC Name:
- 20859-02-3
- Reference substance name:
- (s)-2-Amino-3.3-dimethylbutyric acid
- IUPAC Name:
- (s)-2-Amino-3.3-dimethylbutyric acid
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzuchten GmbH & Co. KG, Borchen, Germany
- Age at study initiation: males: 9 weeks; females: 9 weeks
- Weight at study initiation: males: 431 - 486 g; females: 387 - 440 g
- Caging: Macrolon cages type IV
- Diet (e.g. ad libitum): ad libitum, Standard Diet ssniff G, "Special diet for guinea pigs", supplied by ssniff Spezialdiäten GmbH, Soest, Germany
- Water (e.g. ad libitum): water was provided using a time switched drinking water system
- Acclimation period: The animals were kept 6 days under test conditions before application of the test substance
ENVIRONMENTAL CONDITIONS
- according to guideline
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Physiological saline solution (0.9%)
- Concentration / amount:
- Preliminary test: 1.) irritant concentration, intracutaneous: 1%; 2.) irritant concentration, epidermal: 50%; 3.) non-irritant concentration, epidermal: 10%.
Selected concentration of the test substance in the vehicle in main study:intracutaneous application: 1 % ; after 1 week, epidermal application: 50% ; 2 weeks after that (challenge), epidermal application: 10% .
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Physiological saline solution (0.9%)
- Concentration / amount:
- Preliminary test: 1.) irritant concentration, intracutaneous: 1%; 2.) irritant concentration, epidermal: 50%; 3.) non-irritant concentration, epidermal: 10%.
Selected concentration of the test substance in the vehicle in main study:intracutaneous application: 1 % ; after 1 week, epidermal application: 50% ; 2 weeks after that (challenge), epidermal application: 10% .
- No. of animals per dose:
- Number of groups: 2 control groups, 1 treatment group
Animals per group:
Control group 1: 6 (Nos. 1- 3 m, 4- 6 f); Control group 2: 6 (Nos. 7- 9 m, 10-12 f); Treatment group: 10 (Nos. 13-17 m, 18-22 f) - Details on study design:
- RANGE FINDING TESTS:
In preliminary tests, the maximum non-irritating concentration for the intracutaneous or the slight to moderate irritating concentrations for the epidermal application during the induction phase as well as a non-irritating concentration for the epidermal application during the challenge phase were determined.
MAIN STUDY
A. INDUCTION EXPOSURE
1.) Intracutaneous application:
- Day of application: Day 1
- Immunostimulation: Freunds Gomplete Adjuvant (FGA), batch No. 3231, supplied by Difco Laboratories, Detroit, Michigan, USA
- Vehicle: Physiological saline solution (0.9%), batch No. CM 3590 Al, supplied by Fresenius AG, Bad Homburg, Germany
- Concentration of the test substance in the vehicle: 1%
- Application Volume: 0.1 ml
- Application Site: Scapular area
- Number of Applications: Total 6; 2 x FGA/physiol. saline solution (1:1); 2 x test substance solution; 2 x test substance solution/FCA (1:1)
- Animals of the control group: Identical treatment, however, the vehicle was used instead of the test substance solution.
2.) Epidermal application:
- Day of application: Day 8
- Route of application: Occlusive patch
- Duration of application: 48 h
- Patch material: Filter paper with plastic foil backing (3 x 4 cm)
- Vehicle: Physiological saline solution (0.9%), batch No. CM 3590 Al, supplied by Fresenius AG, Bad Homburg, Germany
- Concentration of the test substance in the vehicle: 50% (slightly to moderately irritant concentration)
- Amount applied: ca. 1 g
- Application Site: Scapular area
- Number of Applications: 1
- Animals of the control group: Identical treatment, however, the vehicle was used instead of the test substance solution.
B. CHALLENGE EXPOSURE
- Day of application: Day 22
- Route of application: Epidermal (occlusive patch)
- Duration of application: 24 hours
- Patch material: Leukotest(R) supplied by Beiersdorf AG, Hamburg, Germany
- Vehicle: Physiological saline solution (0.9%), batch No. CM 3590 Al, supplied by Fresenius AG, Bad Homburg, Germany
- Concentration of the test substance in the vehicle: 10%
- Application volume: 0.2 ml
- Application sites: Right flank (vehicle); Left flank (test substance)
- Number of applications: 2
- Assessment of the reactions at the application sites: Days 24 and 25 (24 and 48 hours after the end of exposure)
- Animals of the control group 1: Identical to treatment of animals of the test substance group. The control animals Nos. 1-3 and 4-6 were used.
- Repetition of the challenge: As the results of the first challenge were unequivocal, no second challenge was performed. The scheduled control group animals Nos. 7-9 and 10-12 were left untreated. - Challenge controls:
- Induction exposure of the control animals:
Identical treatment like test animals, however, the vehicle was used instead of the test substance solution.
Challenge exposure:
Animals of the control group 1: Identical to treatment of animals of the test substance group. The control animals Nos. 1-3 and 4-6 were used. - Positive control substance(s):
- yes
- Remarks:
- 1,4- phenylenediamine x 2 HCl
Results and discussion
- Positive control results:
- Proof of the sensitivity of the Guinea Pig Strain:
Last examination: April 1993, test substance: 1,4-phenylenediamine x 2 HCl, Study No. 895140,
result: all animals showed signs of sensitization.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- L-Tert-Leucine was applied to the skin of guinea pigs to determine its sensitizing properties by the maximization test method.
Following epidermal challenge, none of the animals showed changes at the exposed skin areas.
None of the animals of the control group showed changes at the exposed skin areas.
L-Tert-Leucine has no sensitizing properties on the skin of the guinea pig.
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