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EC number: 500-062-3 | CAS number: 28390-91-2
- 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
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:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No guideline but according to Magnusson & Kligman
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Principles of method if other than guideline:
- according to Magnusson,S. and Kligman,J. Maximisation test. J. Invest. Derm. 52, 268 - 276 (1969) and Contact Dermatitis 6, 46 - 50, (1980)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- At beginning the guinea pigs were 10 weeks old (267 - 400 gm, body weight) . They were housed individually in Macrolon cages (type3) , and individually identified with ear tags. They were kept at constant room temperature (21 +/- 2°C) and a humidity of 50 +/- 10%, and on a 12 hour dark/light cycle. All animals received diet and water ad libitum.
The sensitivity of the strain was tested every 6 months with p-phenylendiamine - Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- 10% in acetone
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 10% in acetone
- No. of animals per dose:
- 10 males and 10 females per group
- Details on study design:
- First induction with 0.1 ml Freund's adjuvant intradermally, and test substasnce epidermally directly on the injection site with occlusive dressing (24 hours).
Second induction week test substance epidermally applied with occlusive dressing (application sites pretreated with 10% lauryl sulfate as an open application)
Challenge: 14 days later substance applied on filter paper to the shaved flank with occlusive dressing for 24 hours.
24 and 48 hours later the skin reactions were scored
A control group received the same treatment but with out test substance. - Challenge controls:
- The maximum sub-irritant concentration was used for the challenge reactions.
- Positive control substance(s):
- no
- Statistics:
- no statistics was applied
- Positive control results:
- performed every 6 months to prove the sensitivity of the guinea pig strain . no data in the report
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no signs of toxicity
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of toxicity.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no observations
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no observations.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- erythema and oedema reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- erythema and oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: erythema and oedema.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Whlie 5/20 animals showed a skin reaction with oedema and erythema in the treated group no reaction were found in the control group (0/20).
The result shows that MY 720 has a weak skin sensitizing potential, which does however not lead to labelling - Executive summary:
Whlie 5/20 animals showed a skin reaction with oedema and erythema in the treated group no reaction were found in the control group (0/20). The result shows that MY 720 has a weak skin sensitizing potential, which does however not lead to labelling
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The tests in Guinea pig showed a weak potential to cause skin sensitization. This has also been observed in workers exposed to the compound as shown in chapter 7.10.4.
Most epoxy compounds have a potential to cause skin sensitization, if sufficiently soluble in water or organic solvents. This is also the case for TGMDA which has 4 epoxid groups.
Migrated from Short description of key information:
A modified maximization test was performed.The substance is considered to be a weak skin sensitizer
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
TGMDA is a skin sensitizier in animals and man. However, no test for respiratory sensitization has been conducted in animals and no case reports are available indicating that this substance is a respiratory sensitizer in Humans.
In addition, none of the industrial epoxides used at high tonnage levels have indicated that they are respiratory sensitizers despite the fact that all are skin sensitizers
In the absence of such data it has to be assumed that TGMDA is devoid of a respiratory sensitization potential.
Migrated from Short description of key information:
No respiratory sensitization tests can be eprformed as there is no validated test system available. Based on experience with other epoxy compounds, respiratory sensitization is rather unlikely, as for only few epoxy compounds case reports are available indicating that respiratory sensitization has occurred in the past.
Justification for classification or non-classification
Based on its potential to cause skin sensitization in animals and man, TGMDA is classified as Xi, R43 for skin sensitization.
No classification and lebelling is requierd for respiratory sensitization as this is unlikely and, in the absence of relevant data, not justified.
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