Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylvaleraldehyde
EC Number:
204-605-2
EC Name:
2-methylvaleraldehyde
Cas Number:
123-15-9
Molecular formula:
C6H12O
IUPAC Name:
2-methylpentanal
Details on test material:
- Name of test material: Methylpentanal

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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