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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-09-03 to 1987-10-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP but internally audited. Scientifically acceptable study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
3 rats / sex instead of 5 rats / sex
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyruvaldehyde
EC Number:
201-164-8
EC Name:
Pyruvaldehyde
Cas Number:
78-98-8
Molecular formula:
C3H4O2
IUPAC Name:
2-oxopropanal

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach, Germany
- Age at study initiation: 8 to 9 weeks
- Mean weight at study initiation: males: 270g, females: 196 g (no animal exceeding +/- 20% of the mean weight)
- Fasting period before study: 16 h
- Housing: Stainless steel wire mesh cage (Type DK III)
- Diet: ad libitum (except during exposition)
- Water: ad libitum (except during exposition)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Air changes: not specified ("fully air conditioned")
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: To: 1987-09-03 to 1987-09-17

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass frit (grain size 90-150 µm.) filled with product, dissipated into glass tubes containing animals; exhaust vent
- Exposure chamber volume: not specified
- Method of holding animals in test chamber: not restrained
- Source and rate of air: 200 L / h

- System of generating aerosols: air flowing through product in glass frit
- Treatment of exhaust air: vented
- Temperature, humidity, pressure in air chamber: ambient (laboratory conditions: 19 to 25°C)

Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
mean: 13,6 mg/L (calculated by a net total of 19.1 g test item spent in 1400 L air)
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs on workdays, fatalities daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 13.6 mg/L air
Based on:
test mat.
Remarks on result:
other: nominal concentr.
Mortality:
no
Clinical signs:
other: During exposure: eyelid closure, respiratory rate increased, panting, respiratory sounds, reddish discharge from nose After exposure: respiratory sounds, reddish discharge from nose (tested positive for blood), stilted gait
Body weight:
not documented
Gross pathology:
no abnormalities detected
Other findings:
no

Applicant's summary and conclusion