Registration Dossier
Registration Dossier
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EC number: 217-886-1 | CAS number: 1999-85-5
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 15 July 2011 - 03 August 2011
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The study has many deviations and the information in the report is incomplete.
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)
- Principles of method if other than guideline:
- The study has many deviations and the information in the report is incomplete.
- Nothing on particle size: To allow for exposure of all relevant regions of the respiratory tract, aerosols with
mass median aerodynamic diameters (MMAD) ranging from 1 to 4 μm with a geometric standard deviation (σg) in the range of 1.5 to 3.0 are recommended. No information on this has been provided.
- No information on nominal/actual concentration.
- No information on chamber temperature and humidity.
- No information on the experimental setting and air pressure, under/over pressure? No description of the equipment.
- No details on chamber airflow and monitoring.
- The laboratory has no GLP accreditation.
- No details on animal housing and actual environmental conditions.
- It is not mentioned if water/diet is analyzed for contaminants. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
- EC Number:
- 217-886-1
- EC Name:
- α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
- Cas Number:
- 1999-85-5
- Molecular formula:
- C12H18O2
- IUPAC Name:
- 2-[3-(2-hydroxypropan-2-yl)phenyl]propan-2-ol
- Details on test material:
- Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric
- Duration of exposure:
- 4 h
- Concentrations:
- 5120±450 mg/m3
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 120 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 4-hour LC50 > 5120±450 mg/m3
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