Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1955
Report date:
1955

Materials and methods

Principles of method if other than guideline:
To estimate the LD50 value, mice were administered the test substance intraperitoneally and kept for observation for 7 days. A solution of the test substance was prepared on a weight/volume basis. The concentrations were varied to allow administration of a constant volume of 0.015 mL/g bw.
GLP compliance:
no
Remarks:
performed prior to GLP
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-amino-2-ethylpropanediol
EC Number:
204-101-2
EC Name:
2-amino-2-ethylpropanediol
Cas Number:
115-70-8
Molecular formula:
C5H13NO2
IUPAC Name:
2-amino-2-ethylpropanediol
Details on test material:
- Name of test material (as cited in study report): R-10
- Lot/batch No.: 396658R-10

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 15 g, on average

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: A solution of the test substance with an unknown vehicle was prepared
Details on exposure:
A solution of the test substance was prepared on a weight/volume basis. The concentrations were varied to allow administration of a constant volume of 0.015 mL/g bw.
Doses:
250, 500, 750, 1000, 1250 and 1750 mg/kg bw
No. of animals per sex per dose:
10 per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
Statistics:
The approximate LD50 doses were stimated by the method of Miller and Tainter, Proc. Soc. Exper. Biol. and Med. 1944; 57:261

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
790 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Range: 790 ± 120 mg/kg bw
Mortality:
In the 50, 500, 750, 1000, 1250 and 1750 mg/kg bw dose groups, the mortality was 0, 1, 4, 8, 9 and 10, respectively (see Table 1).

Any other information on results incl. tables

Table 1: Mortality per dose group administered the test substance

Dose (mg/kg bw)

Number of animals treated

Mortality

250

10

0

500

10

1

750

10

4

1000

10

8

1250

10

9

1750

10

10

Applicant's summary and conclusion