2-isopropoxyethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Unnamed

Year:

2009

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-isopropoxyethanol

EC Number:

203-685-6

EC Name:

2-isopropoxyethanol

Cas Number:

109-59-1

Molecular formula:

C5H12O2

IUPAC Name:

Propan-2-ol

Details on test material:

- Name of test material (as cited in study report): 2-(1-Methylethoxy)ethanol
- Molecular formula (if other than submission substance): C5H12O2
- Molecular weight (if other than submission substance): 104.15
- Analytical purity:=> 99.5%
- Impurities (identity and concentrations): water (<0.1%)
- Lot No.: 30321
- Stability under test conditions: The stability of test material was identified by analysis of the remainder.
- Storage condition of test material: under room temperature

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Inc. Atsugi
- Age at study initiation: 5 weeks old- Fasting period before study: 18 hr
- Housing: Animals were individually housed in metallic cages with wire mesh bottoms
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:9 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0~25.0
- Humidity (%): 40.0~75.0
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water for injection

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 ml/kg b.w.

Doses:

0, 2000 mg/kg b.w.

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observation: Clinical observation was performed hourly to 6 h afterwards consecutively until one hour on the dosage day and performed once a day from the next day.
weighing: Animals were weighed just prior to administration, and on Day 2, 4,8,11 and 15.
- Necropsy of survivors performed: yes

Statistics:

The means and standard deviation were calculated body weight, t-test of Student or t-test of Aspin-Welch was conducted.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed in both sexes.

Clinical signs:

other: Reddish urine was observed from 3 or 4 hours to the next day in both sexes in the 2000 mg/kg groups. Decreased fecal volume was observed at the next day of administration in both sexes in the 2000 mg/kg groups.

Gross pathology:

There were no changes in gross pathological findings in any of the treatment groups.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 values of this substance are considered as >2000 mg/kg.

Executive summary:

A single dose oral toxicity test of 2 -isopropoxyethanol was carried out in accordance with the OECD Test Guideline 401. In this study, no deaths occurred in either sex and the LD50 values were found to be above 2000 mg/kg in both sexes. Reddish urine and decreased of body weight and fecal volume were observed in this study.