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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
exposure time only 1 hour
Principles of method if other than guideline:
Dynamic inhalation method; whole-body - head/nose exposure with analytical and nominal concentration determination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-methylpyrrolidine
EC Number:
204-438-5
EC Name:
1-methylpyrrolidine
Cas Number:
120-94-5
Molecular formula:
C5H11N
IUPAC Name:
1-methylpyrrolidine
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight: 200 - 300 g
The animals were held in air-conditioned rooms with a room temperature of 22 +/- 2°C and a relative humidity of 55 +/- 10%.
Air changing: 10- to 15-fold
Day/night rhythm: 12 h dark, 12 h light
Type of cage: Makrolon type 3 (23 x 39cm2)
Animals per cage: 2
Animal identification: via ear marks
The animals were offered a standard animal laboratory diet as well as drinking water ad libitum.
TEST ANIMALS
- Weight at study initiation: 200-300 g
- Housing: 2 animals per cage, Makrolon type 3 (23 x 39cm2)
- Diet: standard animal laboratory diet, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 22 +/- 2°C
- Humidity (%): 55 +/- 10%.
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

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: Makrolon animal tubes
- Exposure chamber volume: 28.5 L
- Source and rate of air: continuous airation, 600 L/h
- System of generating particulates/aerosols: diffuser nozzle

TEST ATMOSPHERE
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
1 h
Concentrations:
4.5 and 10.1 mg/L (nominal)
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.5 - < 10.1 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: by applying Habers' law (c x t = k) for time extrapolation (1 h to 4 h exposure): LC50 > 1.1 < 2.5 mg/L air
Mortality:
4.5 mg/L: no mortality
10.1 mg/L: all animals died
Clinical signs:
other: During exposure: In the lowest concentration male and female rats showed a slight reduced spontaneous activity as well as a slight reduced rection of outer stimuli; furthermore slight gasping, slight constricted palpebral fissures and slight increased sa
Body weight:
not examined
Gross pathology:
Animals that died (high concentration): 10 of 20 rats showed the following changes of the lung: alveolar emphysema, petechiae and focal atelectasis.
Sacrificed animals: 1 of 20 rats showed isolated petechia (low concentration).

Applicant's summary and conclusion