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EC number: 271-766-3 | CAS number: 68607-67-0
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 11 - July 5, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The substance is a reaction product of formaldehyde and amine and similar to the registered substance. However, this analgogue material has a lower molecular weight and is more irritating to skin, suggesting that this is likely to be more hazardous by inhalation than the substance being registered.
No further animal testing can be justified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- Formaldehyde, reaction products with ethylenediamine
- EC Number:
- 281-928-5
- EC Name:
- Formaldehyde, reaction products with ethylenediamine
- Cas Number:
- 84066-92-2
- IUPAC Name:
- Formaldehyde, reaction products with ethylenediamine
- Test material form:
- other: liquid
- Details on test material:
- Name: Formaldehyde, reaction product with ethylenediamine
CAS No.: 84066-92-2
Batch No.: PK280-61
Purity: 100%
Colour: colourless to yellow
Constituent 1
- Specific details on test material used for the study:
- Similar reaction product to substance being registered, but lower molecular weight amine which will have a higher vapour pressure and potentially more irritaitng.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- Air Supply: Filtered air was supplied by an air compressor (Powerex Model: SES05) to the spray atomization nozzle. Additional compressed mixing air supplied from the air compressor was introduced into the chamber to help uniformly distribute the test atmosphere by creating a vortex at the chamber inlet. Compressed airflow was measured with a Mass Flowmeter. Chamber airflow was monitored throughout the exposure period and recorded periodically
- Duration of exposure:
- < 4 h
- Concentrations:
- After establishing the desired generation procedures during pre-test trials, twenty healthy rats were selected for test and equally distributed (5 per sex/group) into two exposure levels. Exposure levels of 1.0 and 5.0 mg/L were selected for testing.
- No. of animals per sex per dose:
- 10 Males and 10 Females. The females assigned to test were nulliparous and non-pregnant.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.04 - < 5.12 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
Any other information on results incl. tables
1.04 mg/L
The gravimetric and nominal chamber concentrations were 1.04 and 10.95 mg/L respectively. The mass median aerodynamic diameter was calculated to be 1.94 μm based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler.
All animals survived exposure to the test atmosphere. Following exposure, all rats exhibited abnormal respiration. In addition, two males and one female showed signs of abdominal distention and/or ano-genital staining and reduced fecal volume. Ocular and nasal discharge and facial staining were also noted for this female. All five males and four female recovered from the above symptoms by Day 6. Although all rats lost body weight by Day 1 and/or through Day 3, all animals showed a weight gain over the course of the 14 day study. Apart from irregular respiration persisting through Day 14, the fifth female recovered from all other symptoms by Day 12 and showed improved health through weight gain by study termination (Day 14). No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
5.12 mg/L
The gravimetric and nominal chamber concentrations were 5.12 and 99.61 mg/L respectively. The mass median aerodynamic diameter was calculated to be 2.36 μm based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler.
Following exposure to the test atmosphere, all rats exhibited clinical signs including abnormal respiration, hypoactivity, nasal and ocular discharge, ano-genital staining, tremors and/or an unthrifty appearance. One female was found dead on Day 1, three males and a second female died on Day 2 and a third female died by Day 3. The fifth male showed signs of opacity in one eye, a
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the single exposure acute inhalation LC50 of the test substance is between 1.04 mg/L and 5.12 mg/L in male and female rats. Based on the results of this study, Formaldehyde, reaction product with ethylenediamine is assigned EC classification Acute Toxic 4.
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