4-hydroxy-4-methylpentan-2-one

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

-no data tables provided

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxy-4-methylpentan-2-one

EC Number:

204-626-7

EC Name:

4-hydroxy-4-methylpentan-2-one

Cas Number:

123-42-2

Molecular formula:

C6H12O2

IUPAC Name:

4-hydroxy-4-methylpentan-2-one

Details on test material:

- Name of test material (as cited in study report): diacetone alcohol (DAA)
- Physical state: Stated in the report as a "widely used solvent"
- Analytical purity: Not reported
- Lot/batch No.: Reference PER 47657/2
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shell Toxicology Laboraotry (Tunstall) Breeding Unit
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: Not reported
- Fasting period before study: 18 h overnight
- Housing: Four animals/sex were housed in each cage.
- Diet (e.g. ad libitum): rat food (PRD, Labsure Animal Foods Ltd.), ad libitum
- Water (e.g. ad libitum): filtered but untreated water from the public supply, given ad libitum after exposure to test article
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature, 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

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 / CHAMBER DESCRIPTION
- Exposure apparatus: Whole body exposure in chambers
- Exposure chamber volume: 7 Litres
- Method of holding animals in test chamber: Glass chambers are fitted with carriers to accomodate 5 animals each.
- Source and rate of air: minimal rate of 10 L/min
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: Test atmospheres were generated using a thermostatted wick-type saturator.
- Method of particle size determination: Not applicable
- Treatment of exhaust air: Not reported
- Temperature, humidity, pressure in air chamber: Not reported

TEST ATMOSPHERE
- Brief description of analytical method used: DAA concentrations were determined using a heated total hydrocarbon analyser. This instrument was calibrated using standard diacetone alcohol/air mixtures prepared in Teflon FEP plastic bags.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Not applicable
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Not reported

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

7.6 mg/L (range 7.2 to 8.1 mg/L)

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Initial and 14-day body weights were recorded.
- Necropsy of survivors performed: no
- Other examinations performed: Animals were observed daily for toxic signs over the following 14 days.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

>= 7.6 mg/L air

Exp. duration:

4 h

Mortality:

Exposure to concentrations of 7.6 (range 7.2 to 8.1) mg/L did not result in any mortalities.

Clinical signs:

other: Rats showed no toxic signs either during exposure or during the 14-day observation period.

Body weight:

Body weight data were not reported.

Gross pathology:

Not conducted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Executive summary:

The potential acute inhalation toxicity of diacetone alcohol was assessed in Wistar rats in a study similar in methodology to OECD Guidelines for the Testing of Chemicals No. 403 (Cassidy and Blair, 1978). Groups of 5 male and 5 female Wistar rats were exposed to 7.6 mg diacetone alcohol vapour /L (range 7.2 to 8.1 mg/L) for 4 hours via whole-body exposure in test chambers. Test atmospheres were generated using a thermostatted wick-type saturator and the test atmosphere was passed through each chamber at 10 L/minute. During the exposure, continuous analysis of the atmosphere was performed. The animals were observed for toxic signs throughout exposure and for 14 days after. No animals died, and no adverse effects were reported during exposure or during the 14-day observation period. The inhalation LC0 of diacetone alcohol was reported to be greater than 7.6 mg/liter.