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EC number: 220-395-5 | CAS number: 2752-17-2
- 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
A reliable, GLP study was conducted in guinea pigs with the read-across substance BDMAEE according to OECD Guideline 406. Based upon the observations made in the assay, BDMAEE induced at 4%, challenged at 2% and rechallenged at 1% did not cause delayed contact hypersensitivity in guinea pigs (n=20, 10 male/10 female). One vehicle control animal died during the study but the death was determined to be due to non-test related factors.
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:
- 1992-07 - 1992-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- One vehicle control animal died. However, the death of this animal was considered not to be related to treatment. This does not seem to have an impact on the reliability of the study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing according to the REACH Regulation. However, this test was performed before entry into force of the REACH Regulation.
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 6933-10-5
- Physical state: liquid
- Analytical purity: responsibility of the sponsor
- Stability under test conditions: no apparent change in the physical appearance of the test article during administration
- Storage condition of test material: responsibility of the sponsor - Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Buckberg Lab Animals, Tomkins Cove, New York
- Weight at study initiation: assay: 304-400g; naive control-rechallenge: 489-962g
- Age at study initiation: 4 to 6 weeks
- Housing: individually in wire mesh cages
- Diet (e.g. ad libitum): purina guinea pig diet, ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: July 1992 To: August 1992 - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol (induction) and acetone (challenge)
- Concentration / amount:
- 0.3 ml/dose
induction: 4.0% (v/v)
challenge 2.0% (v/v)
rechallenge 1.0% (v/v) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: 80% ethanol (induction) and acetone (challenge)
- Concentration / amount:
- 0.3 ml/dose
induction: 4.0% (v/v)
challenge: 2.0% (v/v)
rechallenge: 1.0% (v/v) - No. of animals per dose:
- dose range: 10 (5m, 5f); test article: 20 (10m, 10f); positive control: 5 (2m, 3f); negative control: 10 (5m, 5f); naive control during rechallenge: 4 (2m, 2f)
- Details on study design:
- RANGE FINDING TESTS:
10 animals (5m, 5f) were each exposed to 4 different concentrations of the test material in ethanol and/or acetone (1.0, 2.0, 4.0, 6.0, 8.0, 10, and 50%)
primary challenge responses were graded
Highest non-irritatting concentration = concentration that induced responses not exceeding 2 + and 2 0 grades in the group of 4 animals.
The dose chosen for induction: 4.0%
The dose chosen for challenge: 2.0%
The dose chosen for rechallenge: 1.0%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 (3 inductions, 1challenge, 1 rechallenge)
- Exposure period: -
- Test groups: test substance in vehicle (80% ethanol)
- Control group: vehicle only
- Site: L shoulder
- Frequency of applications: once a week
- Duration: 6 h
- Concentrations: 4.0%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: day 30 and 37
- Exposure period: -
- Test groups: test substance in vehicle (acetone)
- Control group: vehicle only (left flank), test article (right flank)
- Site: naive site on left side
- Concentrations: 2.0% (challenge), 1.0% (rechallange)
- Evaluation (hr after challenge): 24 and 48h
OTHER:
Due to the irritation observed in the vehicle control animals at challenge, all test article-treated animals, along with an additional group of 4 naive animals were rechallenged at 1.0% (v/v) in acetone, 7 days following the primary challenge.
24h after challenge and rechallenge, all animals were depilated with Neet Cream Hair Remover (Whitehall Laboratories, Inc., New York). A minimum of 2h after depilation test sites were graded. The grading was repeated 24h later (48h grade)
All animals were euthanized by CO2 inhalation at study termination. - Challenge controls:
- The negative control group was challenged with vehicle (acetone) on the left flank and test article on the right flank.
7 days after the primary challenge, all test article treated animals, along with an additional group of 4 naive guina pigs were rechallenged. - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
- Positive control results:
- Sensitising effects observed in all 5 animals receiving the positive control article
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.3
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.1
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.0
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- severity= 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- severity= 3.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- severity= 2.8
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle (acetone)
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle (acetone)
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.0
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.0%
- No. with + reactions:
- 1
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.0%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- severity= 0.1
- Reading:
- other: naive control
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- severity= 0.0
- Reading:
- other: naive control
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.0%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- severity= 0.0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the observations made in the assay, the test article BDMAEE induced at 4.0%, challenged at 2.0% and rechallenged at 1.0% did not cause delayed contact hypersensitivity in guinea pigs. The substance BDMAEE is therefore not to be classified as skin sensitizer according to the CLP Regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No reliable in vivo skin sensitisation study is available with the test substance. The read-across substance BDMAEE was found to be non-sensitising in a Guinea pig maximization study.
BDMAEE induced at 4%, challenged at 2% and rechallenged at 1% did not cause delayed contact hypersensitivity in guinea pigs (n=20, 10 male/10 female). One vehicle control animal died during the study but the death was determined to be due to non-test related factors.
No further skin sensitisation study is required as the substance is classified as corrosive to the skin.
An in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available (initiated before Oct 11th, 2016).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on reliable in vivo skin sensitization test results, the read-across substance BDMAEE does not meet the criteria for classification as a skin sensitizer according to EU Directive 67/548/EEC and Regulation 1272/2008. The same is assumed for the test substance BAEE.
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