Isopropylamine

Acute Toxicity: oral

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

yes

Remarks:

only males tested; screening

GLP compliance:

not specified

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopropylamine

EC Number:

200-860-9

EC Name:

Isopropylamine

Cas Number:

75-31-0

Molecular formula:

C3H9N

IUPAC Name:

propan-2-amine

Test material form:

liquid

Details on test material:

Isopropylamine [CAS No. 75-31-0], production quality samples from Union Carbide Corp. (not further specified)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 3 - 4 wk
- Weight at study initiation: 90 -120 g
- Fasting period before study: unfasted
- Housing: no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Application by gavage through a commercial ball-end needle attached to a calibrated syringe (page 153)

Doses:

no details, dose range with spacing factor 2

No. of animals per sex per dose:

5 males

Control animals:

not specified

Statistics:

Moving average method according to Thompson (1947) und Weil (1983)

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

< 0.25 mL/kg bw

Remarks on result:

other: undiluted

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

< 172 mg/kg bw

Remarks on result:

other: undiluted; transformation from volume (ml/kg bw) to mass (mg/kg bw) on the basis of a density of 0,6871 g/cm3

Effect levels 3

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1.07 mL/kg bw

95% CL:

>= 0.72 - <= 1.59

Remarks on result:

other: 10% solution

Effect levels 4

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 735 mg/kg bw

95% CL:

>= 495 - <= 1 092

Remarks on result:

other: 10% solution; transformation from volume (ml/kg bw) to mass (mg/kg bw) on the basis of a density of 0,6871 g/cm3

Mortality:

Time to death: 7 min. - 4d (undiluted), 4h - 14d (10% solution)

Clinical signs:

other: lethargy, labored breathing, piloerection, prostration

Gross pathology:

lung hemorrhage; kidney and adrenal congestion; gastric and intestinal hemorrhage, ulceration
Most surviving animals were without significant gross pathology (page 163)

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of this study, the LD50 in male rats was < 172 mg/kg bw

Executive summary:

Five male Wistar rats per group were gavaged with the test substance in doses spaced by a factor of 2 to derive LD50 values. The animals were kept for a 14 days observation period. Under the conditions of this study, the LD50 in male rats was < 172 mg/kg bw. Gross necropsy showed lung hemorrhage, kidney and adrenal congestion, gastric and intestinal hemorrhage and ulceration.