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EC number: 200-291-6 | CAS number: 56-84-8
- 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
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- The "maximisation test" of B. Magnusson and A. M. Kligman modified according to Maurer & Hess was performed to reveal a possible sensitising potential of "L-Asparaginsäure". Investigations performed were in conformance with the EC-directive 96/54, 8.6., "Skin Sensitisation" and the OECD-guideline 406, "Skin Sensitisation". As the test substance was insoluble in a variety of solvents, the protocol according to Maurer and Hess was followed (Th. Maurer and R. Hess (1989). The Maximization test for skin sensitization potential - updating the standard protocol and validation of a modified protocol. Fd. Chem. Toxic. Vol. 27, No. 12, p. 807-811).
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Supplier: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen.
Species, strain: Supplier: Guinea pigs, Dunkin Hartley, HsdPoc:DH.
Sex, specification: Female healthy young adult and non pregnant animals
Age of the animals: Approx. 4 - 7 weeks at the first application.
Weight range of the animals at the first application: 211 g to 389 g.
Room temperature: Average of 22 °C, continuous control and recording
Relative humidity: Average of 50.8 % in step 1, of 63.2 % in step 2; continuous control and recording.
Air exchange: Approx. 12/h.
Light: Only artificial light from 6.00 a.m. to 6.00 p.m.
Cages: Until Day 0: Makrolon cages type III (23 cm x 39 cm bottom area, 18 cm height) with wire mesh lids, single caging. From Day 0: group caging in plastic containers (46 cm x 105 cm x 36 cm), partly shaded, 1 group per container.
Feed: Altromin Maintenance Diet No. 3122, rich in crude fibers, ad libitum, offered in stainless steel containers.
Bedding material: Wood chips (aspen). Reduction of microorganisms by autoclaving.
Water: Tap water offered in Makrolon bottles with stainless steel canules ad libitum.
Acclimatisation: 4 days. - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 % (w/w) in white petrolatum for the first epicutaneous induction,
50 % (w/w) in white petrolatum for the second epicutaneous induction and
50% (w/w) in white petrolatum for the challenge exposure.
A test substance concentration of 50 % (w/w) in white petrolatum was the highest technically feasible concentration. - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 % (w/w) in white petrolatum for the first epicutaneous induction,
50 % (w/w) in white petrolatum for the second epicutaneous induction and
50% (w/w) in white petrolatum for the challenge exposure.
A test substance concentration of 50 % (w/w) in white petrolatum was the highest technically feasible concentration. - No. of animals per dose:
- 2 x 10 animals for the test substance group; 2 x 5 animals for the control group.
- Details on study design:
- The study was performed in two consecutive steps: In the first step 10 control and 5 test substance animals were used and as negative results were obtained, additional 10 + 5 animals were used.
As the test substance was insufficiently or not at all soluble in water, acetone, DMSO and ethanol, white petrolatum (ÖAB9) was used as a vehicle and as a reference substance for the epicutaneous induction exposures and for the challenge exposure.
First induction exposure on Day 0: intradermal injections of FCA (to enhance a possible sensitisation) and immediately afterwards epicutaneous application of the test substance to the sites of the intradermal injections. Application site was an area of approx. 2 cm x 4 cm in the interscapular region. The exposure time was 24 hours.
Second induction exposure on Day 8: epicutaneous application of the test substance to the sites of the intradermal injections. The exposure time was 48 hours.
Challenge exposure on Day 22: epicutaneous application of the test substance to the left flanks and application of the vehicle to the right flanks of all animals. Exposure for 24 hours. - Challenge controls:
- Epicutaneous application of the test substance to the left flanks and application of the vehicle to the right flanks of all animals, including the control animals.
- Positive control substance(s):
- yes
- Remarks:
- periodic check with hexylcinnamic aldehyde
- Positive control results:
- 80 % of the positive control animals were sensitized.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results of this study, L-aspartic acid needs not to be labelled with "R43 May cause sensitisation by skin contact".
- Executive summary:
The "maximisation test" of B. Magnusson and A. M. Kligman modified according to Maurer & Hess was performed to reveal a possible sensitising potential of "L-Asparaginsäure". Investigations performed were in conformance with the EC-method B.6., "Skin Sensitisation" and the OECD-guideline 406, "Skin Sensitisation". As the test substance was insoluble in a variety of solvents, the protocol according to Maurer and Hess was followed.
The study was performed in two consecutive steps: In each step 10 female guinea pigs were used as a test substance group and another 5 females were used as a negative control group. Immediately after the injection of Freund's complete adjuvant the test substance was administered epicutaneously on the same area. One week later a second epicutaneous induction exposure followed and two weeks afterwards the epicutaneous challenge exposure. Test substance concentrations were:50 % (w/w) in white petrolatum for the first epicutaneous induction,
50 % (w/w) in white petrolatum for the second epicutaneous induction and
50% (w/w) in white petrolatum for the challenge exposure.
Results:
Skin reactions after the challenge exposures:
The control sites of all animals of both groups were normal at each reading time.
After the challenge exposures, no animal of the test substance group had positive skin reactions at the test substance treated sites 24 hours and/or 48 hours after the end of the exposure. No adverse skin reactions were observed in the control animals. Therefore no animal of the test substance group was regarded to be sensitised.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
No sensitisation was observed in a guinea pig maximisation test.
Justification for selection of skin sensitisation endpoint:
the key study is selected.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There is no indication to justify a classification.
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