35XY60

Acute Toxicity: inhalation

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 for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

3,5-xylenol

EC Number:

203-606-5

EC Name:

3,5-xylenol

Cas Number:

108-68-9

Molecular formula:

C8H10O

IUPAC Name:

3,5-dimethylphenol

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 or test system 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:

other: 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