2,4-dichlorobenzyl alcohol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997-06-18 to 1997-07-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Experimental study according to guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Version / remarks:

The study design was in compliance with EEC, OECD, EPA and JMAFF test guidelines for acute inhalation studies.
Deviation: The test atmosphere could not be produced from the test substance using the Wright dust generator because of the crystalline nature of the test substance. A solution in acetone (50:50 w/w) was prepared and a liquid draplet aerosol generated from the solution using a stainless steel concentric jet atomiser. This deviation from the study protocol was necessary to conduct the study.

Deviations:

yes

Principles of method if other than guideline:

The study design was in compliance with EEC, OECD, EPA and JMAFF test guidelines for acute inhalation studies.
Deviation: The test atmosphere could not be produced from the test substance using the Wright dust generator because of the crystalline nature of the test substance. A solution in acetone (50:50 w/w) was prepared and a liquid draplet aerosol generated from the solution using a stainless steel concentric jet atomiser. This deviation from the study protocol was necessary to conduct the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dichlorobenzyl alcohol

EC Number:

217-210-5

EC Name:

2,4-dichlorobenzyl alcohol

Cas Number:

1777-82-8

Molecular formula:

C7H6Cl2O

IUPAC Name:

(2,4-dichlorophenyl)methanol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Ltd. Manston Road, Margate, Kent, England
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 185-204 g, female: 175-200 g
- Fasting period before study: no
- Housing: 5 animals per cage (same sex), metal cages with wire mesh floors
- Diet: ad libitum, Special Diet Services RM 1
- Water: ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20
- Humidity (%): 46-61
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: acetone

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 30 L
- Method of holding animals in test chamber: The rats were held for exposure in moulded polycarbonate tubes which were attached at evenly spaced ports in the cylindrical section of the chamber. The tubes were tapered at one end to allow the snout only to project into the chamber. Ibe other end was closed by insertion of an expanded plastic bung. A push rod passed through the centre of the bung and was adjusted to maintain the position of a rat during exposure.
- Source and rate of air: clean dried air, 15 L/min
- Method of conditioning air: aerosol generator
- System of generating particulates/aerosols: concentric jet atomiser
- Method of particle size determination: A sample (1.5 L) of the chamber atmosphere was drawn through a Marple (Model 296) Personal Cascade Impactor (Graseby Andersen Ltd., Georgia, USA) with stainless steel collection substrates and a Whatman GF/A filter. The sample volume was measured using a wet-type gas meter placed in-line with the pump. The sampling rate (2 1/minute) was set before use, using a tapered tube rotameter. Each collection substrate was weighed before and after sampling.
- Temperature, humidity, pressure in air chamber: 19-20 °C, 42-43 % relative humidity

TEST ATMOSPHERE
- Brief description of analytical method used: Five air samples were taken from the chamber during each exposure and the concentration in the chamber air was determined by chemical analysis.
- Samples taken from breathing zone: no

VEHICLE
- Composition of vehicle: Acetone
- Concentration of test material in vehicle: 50:50 w/w

TEST ATMOSPHERE
- Particle size distribution: total amount collected at 1.5 h was 1936.1 µg and at 3.5 h 2241.5 µg.
- MMAD: 2.9 µm

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

in air: 2.04 mg/L
nominal: 22.2 mg/L

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed continuously for signs of reaction to the test substance during exposure and at least twice daily throughout the observation period. The clinical signs were recorded at the end of the chamber equilibration period, followed by recordings at 0.25, 0.5 and 1.0 hour and at hourly intervals, thereafter, during the exposure. Further recordings were made at 0, 1 and 2 hours post-exposure. During the observation period, the clinical signs were recorded once in the morning and then, following a later check for clinical signs, as deemed necessary. Body weight was determined daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, food and water consumption

Statistics:

No data provided.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.04 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality observed.

Clinical signs:

other: During the exposure all animals showed exaggerated respiratory movements. Following the exposure 3 male and 2 females were lethargic. The fur of all animals was wet around the snout and jaws. During the observation period, exaggerated respiratory movement

Body weight:

There was a slight reduction in the rate of bodyweight gain of male rats on the day following exposure, females were unaffected. Otherwise, the rate of bodyweight gain for test rats was similar to that of the vehicle controls.

Gross pathology:

There were no macroscopic abnormalities in test or control rats.

Other findings:

- Organ weights: The lung weight for test rats was similar to that of the controls.
- Other observations: Food consumption was moderately reduced in male test rats for up to 4 days and slightly reduced in female test rats for 1 - 2 days following exposure. Food consumption for test rats was otherwise similar to that of the vehicle control rats during the observation period. Water consumption for test rats was similar to that of the controls.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information