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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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: Non standard test design, with little reporting detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Inhalation-Risk-Test was performed in principle as described in OECD Guideline 403 (adopted 1981). It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (20°C).
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyric anhydride
EC Number:
202-603-6
EC Name:
Isobutyric anhydride
Cas Number:
97-72-3
Molecular formula:
C8H14O3
IUPAC Name:
isobutyric anhydride
Details on test material:
- Physical state: liquid
no further data provided

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean: male: 228 g; female: 196 g

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
- Source and rate of air: 200L air/h
- System of generating particulates/aerosols: Vapor is generated by bubbling 200 L/h air at 20°C through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 1, 3 and 7 hours.
- Pressure in air chamber: 755 mm/Hg
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
mean: 7 hours: 4.21 mg/L; 3 hours: 4.18 mg/L; 1 hours: 4.27 mg/L
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily, weighing at beginning and at the end of the study
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 4.21 mg/L air
Based on:
test mat.
Exp. duration:
7 h
Mortality:
1 male rat died after 3 h exposure on day one after exposure.
1 male rat died after 7 h exposure on day one after exposure further 3 animals died on day 2.
In the 1 hour exposure test no animal died.
Clinical signs:
other: Eyelid closure, clear and bloody discharge (nose), piloerection and dyspnea were seen as long as the animals were under exposure. At the 7 hour exposure dyspnea and crust formation at the nose were seen until day 6.
Body weight:
Normal body weight gain.
Gross pathology:
All dead animals showed in the heart an acute dilation (right) and an acute congestion. One animal showed a blood filled lung after infarct. In sacrificed animals were no abnormalities detected.

Applicant's summary and conclusion