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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study based on accepted scientific principles, of limited use for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Inhalation hazard test: Exposure to an atmosphere enriched with the test substance at ambient temperature
GLP compliance:
no
Test type:
other: inhalation risk test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Produkt-Nr. 111.184 (= 3,5-dimethyl phenol)
- Molecular formula (if other than submission substance): C8H10O
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: organic
- Physical state: solid
- Analytical purity: specified as "pure"
- Impurities (identity and concentrations): no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. A. Ivanovas, Kisslegg/Allgäu/Germany
- Age at study initiation: no data
- Weight at study initiation: 115 - 140 g (male, female)
- Fasting period before study: 16
- Housing: 5 per cage
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Air-conditioned room
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass tube
- Exposure chamber: 150 mm (diameter) x 1000 mm (length)
- Method of holding animals in test chamber: in a segment of the inhalation tube
- Source and rate of air: micro-filtered pressure air
- Method of conditioning air: passed through a layer of 5 cm finely granulated test substance
- air rate: 480 L/h (( L/min)
- Treatment of exhaust air: exhaust hood
- Temperature, humidity, pressure in air chamber: 24 °C
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
no data, test-substance enriched air (24 °C): < saturation concentration (Cs)
Cs = ~ 0.13 mg/L (based on a vapour pressure of 0.027 hPa at 25 ° and the molecular mass of 122)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1x/d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Hazard level at ambient temperature
Effect level:
> 0.07 mg/L air
Exp. duration:
7 d
Remarks on result:
other: estimated air concentration (as gas) based on saturation (~ 1.3 mg/L), assuming 50 % air saturation under test conditions.
Mortality:
none
Clinical signs:
no particular observations
Body weight:
normal
Gross pathology:
no particular findings

Applicant's summary and conclusion

Conclusions:
LC >0.07 mg/L following 7 days exposure
Executive summary:

LC >0.07 mg/L following 7 days exposure