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EC number: 401-280-0 | CAS number: 91273-04-0 CM 23-376; REOMET 30
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July - August, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing in vivo study dated 1985 available of good quality to meet this endpoint
Test material
- Reference substance name:
- 1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole
- EC Number:
- 401-280-0
- EC Name:
- 1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole
- Cas Number:
- 91273-04-0
- Molecular formula:
- C19 H38 N4
- IUPAC Name:
- bis(2-ethylhexyl)[(1H-1,2,4-triazol-1-yl)methyl]amine
- Details on test material:
- - Physical state: liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 10 weeks old
- Weight at study initiation: 299-416 g
- Housing: individually in Macrolon cages
- Diet: standard guinea pig pellets, NAFAG No.846, ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+3°C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sesame oil and vaseline
- Concentration / amount:
- First induction: 1% in sesame oil
Second induction: 0.4 g paste of 30% test item
Challenge: 0.2 g paste of 30% test item
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil and vaseline
- Concentration / amount:
- First induction: 1% in sesame oil
Second induction: 0.4 g paste of 30% test item
Challenge: 0.2 g paste of 30% test item
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later.
First induction:
Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs as follows: adjuvant and saline (1: 1), test item in sesame oil, test item in the adjuvant saline mixture.
- Control group: yes, treated with adjuvant and the vehicle
- Site: neck
- Concentrations: 1% solution (0.1 ml per injection)
Second induction:
One week after induction the test item was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours).
The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application).
- No. of exposures: one
- Exposure period: 48 h
- Control group: yes, treated with adjuvant and the vehicle
- Site: neck
- Concentrations: 30% test item (approx. 0.4 g test item)
B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with the test item in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours).
- No. of exposures: one
- Day(s) of challenge: Two weeks after the epidermal induction application
- Exposure period: 24 h
- Control group: yes, treated with the vehicle as well as with the test compound
- Site: flank
- Concentrations: 30% test item (approx. 0.2 g test item)
- Evaluation (hr after challenge): 24 h and 48 h
C. CONTROL GROUP
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test item in adjuvant treated animals. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The sensitivity of the strain was checked every six months with Paraphenylene-diamine or Potassium-dichromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- 85 to 95% of the animals were sensitised by the test article under the experimental conditions employed. The test substance is therefore regarded a skin sensitizer.
- Executive summary:
In a guinea pig maximization test according to OECD guideline No. 406, 10 male and 10 female animals were first induced and then challenged with the test article to investigate its sensitization potential. Induction was a two-stage operation: First, three pairs of intradermal injections (0.1 ml per injection) were made into the shaved neck of the animals with a 1:1 mixture (v/v) of adjuvant/saline, 1% of the test substance in sesame oil, and 1% of the test substance in a 1:1 mixture (v/v) of adjuvant/ saline. One week later the test article was incorporated in vaseline (30% concentration) applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; 0.4 g, occluded administration for 48 hours). The application sites were pretreated on the previous day with 10 % sodium lauryl sulfate (open application). Two weeks after the epidermal induction application the animals were tested on the flank with 30% test substance in vaseline and the vehicle alone (patch 2 x 2 cm; 0.2 g, occluded administration for 24 hours). A control group of 10 males and 10 females was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals. Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale.
A second evaluation was made 48 hours after removing the dressings. At the 24 hour time point, 19/20 animals of the test group showed dermal irritation reactions. At the 48 hour time point, 17/20 animals were positive. None of the animals of the control group showed reactions either treated with the vehicle or with the test compound during challenge. In conclusion, under the experimental conditions employed, 85 to 95% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. The test article is therefore regarded as a skin sensitizer in albino guinea pigs and requires classification.
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