Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)
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.