Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
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): 2 - amino-2 - ethyl-1 ,3 - propanediol
- Physical state: Transparent, yellow, viscous liquid
- Analytical purity: 99.4%
- Stability under test conditions: The stability of the test substance was tested by diluting it to 30 and 200 mg/mL in water and storing the solutions in light-proof bottles under refrigeration, in the dark, for 6 days. The test material was stable under these conditions.
- Storage condition of test material: Cool and dark conditions

Test animals

Species:
rat
Strain:
other: SPF, Crj:CD(SD)IGS
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Japan Co., Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 179 - 211 g (mean: 190 g)
- Housing: The animals were housed one per cage in mesh cages
- Fasting: From approximately 16 hours prior to dosing until 4 hours after dosing
- Diet: CRF-1 pellets (Oriental Yeast Co.), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The concentration was adjusted to administer the animals 10 mL/ kg bw
- Amount of vehicle (if gavage): 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: According to OECD 423, the initial dose shoud be 300 mg/kg bw. If no mortalities occur during 2 separate administrations of 300 mg/kg bw (step 1 and 2), the dose should be increased to 2000 mg/kg bw. The 2000 mg/kg bw dose was also administered in two separate groups (step 3 and 4).
Doses:
Step 1: 300 mg/kg bw
Step 2: 300 mg/kg bw
Step 3: 2000 mg/kg bw
Step 4: 2000 mg/kg bw
No. of animals per sex per dose:
3 females per step
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs 5, 15 and 30 minutes; and 1, 2, 4 and 6 hours after dosing, and every day during the observation period thereafter. Body weights were measured before dosing on day 0 and on day 1, 2, 3, 7, 10 and 14.
- Necropsy of survivors performed: Yes. At the end of 14 days, the surviving animals were weighed, sacrificed and examined for gross pathological changes.
Statistics:
An average of the lethal dose was estimated from the numbers of dead animals per each dose. The mean body weight and standard deviation was calculated for each administration day.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effects were observed up to and including the highest dose level. According to OECD 423, the LD50 cut-off is set at 5000 mg/kg bw.
Mortality:
No mortality was observed.
Clinical signs:
No clinical signs were observed during the observation period.
Body weight:
No changes in body weight between the control and treatment groups were observed.
Gross pathology:
No abnormalities were observed in any of the animals in the control or treatment groups.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified