Registration Dossier

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:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid

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