α,α,α',α'-tetramethyl-m-xylene-α,α'-diol

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:

2012

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

Test material information

Constituent 1

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

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