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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
BASF test (inhalation risk test) according to Smyth et al. (1962). The test demonstrated the toxicity of an atmosphere saturated with vapours of the volatile components of the test item at 20 °C.
Reference:
Smyth HF et al. (1962). Am. Ind. Hyg. Ass. J. 23: 95-107.
GLP compliance:
no
Test type:
other: inhalation hazard test
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
IUPAC Name:
Reaction mass of bis(2-hydroxyethanaminium) sulfite and 2-(methylamino)ethanol - oxosulfane oxide (1:1)
Details on test material:
- Name of test material: Kauramin-Härter CE 5196 flüssig; N-Methylaethanolammonium(-hydrogen) sulfit + Aethanolammonium(-hydrogen) sulfit in Wasser (German)
- Physical state: liquid
- Composition of test material, percentage of components: N-Methylethanolamine: 21 %, Ethanolamine: 24.6 %, Sulfur dioxide: 35 %, water: 19.4 %
- Other: pH-neutral mixture

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: purchased from a breeder
- Age at study initiation: young adult

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
- Rate of air: 200 L/hour
- System of generating a saturated vapour atmosphere: air was bubbled through a substance column of about 5 cm above a fritted glass disk in a glass cylinder.
- Temperature in air chamber: 20 °C
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
Saturated atmosphere, enriched with the volatile fraction of the test item
No. of animals per sex per dose:
6 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: group-wise documentation of clinical signs was performed; body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
other: saturated atmosphere
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: no effects
Mortality:
There were no deaths.
Clinical signs:
other: No clinical signs were observed.
Body weight:
No data
Gross pathology:
There were no macroscopic findings.

Applicant's summary and conclusion