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Diss Factsheets
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EC number: 701-365-5 | CAS number: -
- 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)
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11. Aug to 21. Oct. 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
- Principles of method if other than guideline:
- According to the European Discussion Group of Inhalation Toxicologists (EDIT) referring to Botham P.A., Rattraya N.J., Woodcocka D.R., Walsha S.T. and Hexta P.M. "The induction of respiratory allergy in guinea-pigs following intradermal injection of trimellitic anhydride: a comparison with the response to 2,4-dinitrochlorobenzene ", Toxicology Letters, Volume 47, Issue 1, April 1989, Pages 25-39
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White (HOE DHPK (SPFLac))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 to 5 weeks
- Weight at study initiation (mean): males: 250 g; females: 243 g
- Housing: groups of 4 animals
- Diet: Altromin 3112 ad libitum
- Water: tap ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 30 to 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11-Aug-1993 To: 21-Oct-1993
Test system
- Route of induction exposure:
- intradermal
- Route of challenge exposure:
- inhalation
- Vehicle:
- other: intradermal: NaCl
- Concentration:
- males: 150, 210 mg/m³
females: 140, 180 mg/m³ - No. of animals per dose:
- Determination of the tolerance of intradermal injections: 2 animals
Determination of the primary non-irritant concentration (inhalation): 4 animais
Material Control Group: 8 animals
Test Group: 8 animals - Details on study design:
- Animals of the test groups are treated intradermally with the test substance: 0.1 mL 1 %, 5 %, 30 %
Animals of the material control groups are treated with the vehicle only.
Determination of the primary non irritant aerosol concentration: 30 to 200 mg/m³
All animals are challenged by inhalation after three weeks using a primary non irritating concentration of the test substance.
Allergic reactions in the test groups are assessed by changes of lung function parameters compared to the material control groups. - Challenge controls:
- yes
- Positive control substance(s):
- not specified
- Negative control substance(s):
- not specified
Results and discussion
- Results:
- Determination of the tolerance of intradermal injections:
Intradermal injection of 30 % of the test item in physiological saline caused encrustations and beginning necrosis at the application sites. Slight induration was observed after injection of the 5 % formulation. The injection sites treated with 1 % of the test item showed no signs of irritation. Based on these results a 5 % solution was chosen for intradermal induction at day 1.
Determination of the primary non-irritant aerosol concentration:
A slight increase in respiratory rate occurred during exposure to approx. 200 mg/mg air. No marked changes in respiratory rate were observed during exposure to approx. 160 mg test item/m³. Therefore this concentration was chosen for inhalation exposure at challenge day 22.
Body weight gain and clinical signs:
The intradermal injections caused encrustations and indurations of the injection sites up to day 8 at the study. Body weight gains were not impaired.
Challenge treatment
– Lung function parameters
Questionable up to slight changes in the respiratory pattern were observed in all animals after onset of exposure. No significant differences were present between the animals of the material control groups and the animals of the test groups.
Based on the results of the present study the test item did not cause a significant allergic response after intradermal induction and respiratory challenge.
- Clinical signs of intoxication
No clinical signs of intoxication were observed.
- Autopsy findings
Autopsy of the animals revealed red patches on the lungs in one animal of each group, respectively. - Positive control results:
- not examined
- Negative control results:
- true negative control substances have not been examined
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Based on the results of the present study the test item did not cause a significant allergic response after intradermal induction and respiratory challenge.
- Executive summary:
A GLP compliant study was conducted according to the European Discussion Group of Inhalation Toxicologists (EDIT) referring to Botham P.A., Rattraya N.J., Woodcocka D.R., Walsha S.T. and Hexta P.M. "The induction of respiratory allergy in guinea-pigs following intradermal injection of trimellitic anhydride: a comparison with the response to 2,4-dinitrochlorobenzene ", Toxicology Letters, Volume 47, Issue 1, April 1989, Pages 25-39
The guinea pigs were placed individually in cylindrical plastic tubes connected with plethysmographs and exposed to specified aerosol concentrations. The plastic tubes leading into the exposure chamber were arranged in such a way that only the noses of the animals were inside the chamber.
The test item was tested for respiratory sensitization in Pirbright White guinea pigs. Induction was carried out by intradermal injection of 0.1 ml the test item (5% solution in physiological saline) at day 1. Animals were challenged at day 22 with approx. 140 - 210 mg of test item / m3 air.
Evaluation of the particle size distribution of the test item aerosol revealed a mass median aerodynamic diameter (MMAD) of 1.8 micrometers and a geometric standard deviation of 1.9. The respiratory pattern changed slightly in some animals during challenge on day 22, but there were no marked differences between the animals induced with the test item and control animals, which received isotonic saline only on the day of induction.
Based on the results of the present study the test item did not cause a significant allergic response after intradermal induction and respiratory challenge.
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.
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