Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 239-556-6 | CAS number: 15520-10-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 14 MAR 1984 to 06 MAY 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets sceintific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Principles of method if other than guideline:
- skin sensitisation test in guinea pigs. Primary irritation phase (1 drop open epikutan). Two days thereafter followed by induction phase (4 intradermal injections with 0.1 ml of 1% (v/v) emulsion, 1 injection per week). Challenge treatment (open epicutan) of animals was done two weeks after last induction injection.
- GLP compliance:
- no
- Type of study:
- intracutaneous test
Test material
- Reference substance name:
- 2-methylpentane-1,5-diamine
- EC Number:
- 239-556-6
- EC Name:
- 2-methylpentane-1,5-diamine
- Cas Number:
- 15520-10-2
- Molecular formula:
- C6H16N2
- IUPAC Name:
- 2-methylpentane-1,5-diamine
- Details on test material:
- - Name of test material (as cited in study report): 2-methylpentanediamine, MPMD
- Substance type: clear, colourless liquid
- Physical state: fluid
- Analytical purity: 90%
- Impurities (identity and concentrations): approx. 10 % 2-ethylbutanediamine
- Composition of test material, percentage of components:
- Isomers composition:
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- primary irritation: 1 drop of 1 or 10 % emulsion of test substance in physiological saline
sensitisation: 4 intradermal injections of 0.1 mL of a 1.0 % emulsion
challenge: 1 drop of 1 or 10 % emulsion of test substance in physiological saline (control group also treated)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- physiological saline
- Concentration / amount:
- primary irritation: 1 drop of 1 or 10 % emulsion of test substance in physiological saline
sensitisation: 4 intradermal injections of 0.1 mL of a 1.0 % emulsion
challenge: 1 drop of 1 or 10 % emulsion of test substance in physiological saline (control group also treated)
- No. of animals per dose:
- 10 male animals per group.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or edema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or edema observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema observed in 8/10 animals, no edema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 8/10 animals, no edema observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema observed in 8/10 animals, no edema observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 8/10 animals, no edema observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or edema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no erythema or edema observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no erythema or edema observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema observed in 10/10 animals, no edema observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 10/10 animals, no edema observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema observed in 8/10 animals, no edema observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: very slight erythema observed in 8/10 animals, no edema observed.
Any other information on results incl. tables
All animals survived throughout the study. Animals challenged with the test material exhibited no potential to produce dermal sensitisation in guinea pigs.
erythema scores:
0: no erythema
1: slight erythema
2: mild erythema
3: moderate erythema
4: severe erythema
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the applied test conditions, the test substance is no skin sensitisiser.
- Executive summary:
In an intracutaneous guinea pig test 10 male guinea pigs were treated with two concentrations of MPMD each (10 % or 1 % of test substance). First Primary irritation was tested (1 drop open epikutan). Two days thereafter 4 intradermal injections with 0.1 ml of 1% (v/v) emulsion (1 injection per week) followed.
After challenge (done open epicutaneous; two weeks after last induction injection) with the test substance animals in the 10 % group showed very slight erythema in the 24 and 48 h reading (i.e. 8/10 and 10/10 animals). In the corresponding control group (animals were only treated once in the same manner as challenge treatment was performed) 8/10 animals showed also slight erythema in the 24 and 48 h reading, revealing the irritant potential of the substance at this concentration level. In the 1 % test group no effects were observed. According to the authors the test material is no skin sensitiser.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)