1,1'-iminodipropan-2-ol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1973

Report date:

1973

Reference 2

Reference Type:

publication

Title:

Comparative acute toxicity and primary irritancy of various classes of amines

Author:

Myers RC, Ballantyne B

Year:

1997

Bibliographic source:

Tox Subst Mechanisms 16:151-194

Materials and methods

Principles of method if other than guideline:

24 hr dosing period followed by a 14 day observation period

GLP compliance:

no

Test type:

other: 24 hr dermal dosing period followed by a 14 day observation period

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-iminodipropan-2-ol

EC Number:

203-820-9

EC Name:

1,1'-iminodipropan-2-ol

Cas Number:

110-97-4

Molecular formula:

C6H15NO2

IUPAC Name:

1,1'-iminodipropan-2-ol

Details on test material:

no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

- Age at study initiation: 3 - 5 month
- Weight at study initiation: 2.0 - 3.0 kg
- Diet and water: Non-fasted animals are maintained on appropriate Rockland diets and water ad lib except during period of manipulation or confinement.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Male albino rabbits, 3 to 5 months of age, are immobilized during the 24-hour contact period with the compound retained unter impervious sheeting on the clipped intact skin of the trunk. Thereafter, excess fluid is removed to prevent ingestion.

Duration of exposure:

24-hours

Doses:

16000, 8000 or 4000 mg/kg

No. of animals per sex per dose:

4 male rabbits/dose level

Control animals:

not specified

Details on study design:

Dosage intervals differ by a factor of 2 in a geometric series.

Statistics:

LD50 was calculated by the moving average method based on a 14-day observation period.

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

8 000 mg/kg bw

Mortality:

Rabbits given 16000, 8000 or 4000 mg/kg resulted in 4/4, 2/4 and 0/4 (dead/dosed),

Clinical signs:

other: Skin irritation consisting of erythema and necrosis where pressure of stocks was present, was observed at all dose levels.

Gross pathology:

Gross pathology consisted of congestion of lungs, livers, spleens and kidneys, mottled livers and opaque stomachs.

Other findings:

no data

Any other information on results incl. tables

Rabbits given 16000, 8000 or 4000 mg/kg resulted in 4/4, 2/4 and 0/4 (dead/dosed), respectively. Skin irritation consisting of erythema and necrosis where pressure of stocks was present, was observed at all dose levels. Gross pathology consisted of congestion of lungs, livers, spleens and kidneys, mottled livers and opaque stomachs.

Applicant's summary and conclusion

Executive summary:

DIPA was applied dermally for 24 hours at doses of 4000, 8000 or 16,000 mg/kg to the intact skin of groups of 4 male rabbits. All rabbits from the 16,000 mg/kg group died while 2 of 4 rabbits from the 8000 mg/kg group died within the 14-day observation period. The dermal LD50 was determined to be 8000 mg/kg using the moving average method of statistical analysis.