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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:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is well documented and acceptable for assessment.

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:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Methylpentanal

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma WIGA, Sulzfeld, Germany (FRG)
- Age at study initiation: no data
- Weight at study initiation (mean): Males: 205 g (test group), 213 g (control group); Females: 195 g (test group), 192 g (control group)
- Fasting period before study: no data
- Housing: no data
- Diet: Herilan MRH of Firma H. EGGERSMANN KG, Germany (FRG), ad libitum
- Water: ad libitum
- Acclimation period: no data

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

IN-LIFE DATES: From: 1978-02-17 To: 1978-03-03

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Chamber, whole body inhalation
- Exposure chamber volume: 180 L
- Source and rate of air: 3000 L/h
- Method of conditioning air: Devolatizer at 90 °C
- System of generating particulates/aerosols: intermixture with flow of fresh air
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data

TEST ATMOSPHERE
- Brief description of analytical method used: Absorbed test substance was determined in Xylol by means of gaschromatography
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle: air

TEST ATMOSPHERE
- Particle size distribution: no data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gaschromatography
Duration of exposure:
4 h
Concentrations:
9.7 mg/L (nominal)
8.4 mg/L (measured)
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: at start, after 7 days and after 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality and clinical signs, daily observed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 8.4 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: Concentration: analytically verified
Mortality:
All animals survived (no mortalities occurred during the 14-days observation period).
Clinical signs:
other: Accelerated respiration, crusted noses, rough fur
Body weight:
No differences were observed compared to the control group.
Gross pathology:
No animal showed any abnormal finding at necropsy.

Applicant's summary and conclusion