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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study and non-guideline study, but basic information given

Data source

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

Materials and methods

Principles of method if other than guideline:
similar to OECD 401
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1-ethylpyrrolidin-2-one
EC Number:
220-250-6
EC Name:
1-ethylpyrrolidin-2-one
Cas Number:
2687-91-4
Molecular formula:
C6H11NO
IUPAC Name:
1-ethylpyrrolidin-2-one
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): N-ethylpyrrolidon
- Molecular weight : 113
- Physical state: liquid
- Analytical purity: > 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The mean body weights for males was 208 g and for females 165 g.
The animals were offered Herilan MRH concentrated feed and water ad libitum. Feed was withdrawn 16 hours before the beginning of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
10.0; 21.5; 31.6 and 50% solution in distilled water in doses of 1,000; 2,150; 3,160 and 5,000 mglkg
No. of animals per sex per dose:
5

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 200 mg/kg bw
Mortality:
see below
Clinical signs:
other: see below
Gross pathology:
Animals that died: Heart: acute dilatation; kidneys: some of them pale; lungs: infarctoid congestion with edematization; intestines: atonic
Sacrificed animals: Organs: no abnormalities detected

Any other information on results incl. tables

Mortality:

 Dose (mg/kg)  Conc. (%)  No. of animals  Died within            
       1 hour  24 hours  48 hours  7 days  14 days
 5,000  50  5 males  0/5  5/5  5/5  5/5  5/5
     5 females  0/5  3/5  4/5  4/5  4/5
 3,160  31.6  5 males  0/5  0/5  1/5  1/5  1/5
     5 females  0/5  2/5  4/5  4/5  4/5
 2,150  21.5  5 males  0/5  0/5  0/5  0/5  0/5
     5 females  0/5  0/5  0/5  0/5  0/5
 1,000  10.0  5 males  0/5  0/5  0/5  0/5  0/5
     5 females  0/5  0/5  0/5  0/5  0/5

Symptoms:

   5,000 mg/kg  3,160 mg/kg  2,150 mg/kg  1,000 mg/kg
 Dyspnea  15 min - 6 d  < 15 min - 4 h  1 h - 5 h  
 Apathy  15 min - 5 d  < 15 min - 4 h  1 h - 5 h  
 Lateral position  1 h - 2 d  30 min - 4 h    
 Abdominal position  30 min - 4 h  2 h - 4 h    
 Dorsal position  4 h      
 Staggering  15 min - 1 d  < 15 min - 4 h    
 Atony  1 h - 4 h      
 Paresis  15 min - 2 d      
 Pain reflex absesnt  1 h      
 Narcotic-like state  1 h      
 Urine orange        1 d - 5 d
 Erythema  1 h - 2 d      
 Exsiccosis  1 h - 2 d      
 Ames blood test  15 min - 6 d  < 15 min - 4 h  1 h - 5 h  

Applicant's summary and conclusion