Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Inhalation Risk Test
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
other: Inhalation Risk Test (IRT)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3,6-Trimethyl-phenol (TMP)
No further data

Test animals

Species:
rat
Strain:
other: Gassner
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE
A continuous air flow (200 l/h) was conducted through a layer of the unchanged test substance in an exsiccator.

No further data on exposure procedure.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
no further data
Duration of exposure:
8 h
Concentrations:
0.59 mg/l; ca. 106.08 ppm (according to the authors)
No. of animals per sex per dose:
12 rats (males and females; no data on sex ratio)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
> 0.59 mg/L air
Exp. duration:
8 h
Remarks on result:
other: no mortality
Mortality:
No deaths occurred.
Clinical signs:
No clinical signs of toxicity were noted.
Body weight:
no data
Gross pathology:
No findings were observed.

Any other information on results incl. tables

No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at room temperature with the volatile parts of the compound. According to the authors, test concentration was 0.59 mg/l (ca. 106.08 ppm). Formation of dust was not observed.

Applicant's summary and conclusion

Executive summary:

No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at room temperature with the volatile parts of the compound. Test concentration was 0.59 mg/l (ca. 106.08 ppm).