1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No details if guideline followed or if to GLP, limited reporting on methods and results

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

Acute inhalation toxicity was assessed in male rats following a 7-hr exposure to DEIPA saturated air.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol

EC Number:

229-764-5

EC Name:

1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol

Cas Number:

6712-98-7

Molecular formula:

C7H17NO3

IUPAC Name:

1-[bis(2-hydroxyethyl)amino]propan-2-ol

Test material form:

other: Vapour or fumes

Details on test material:

- Name of test material (as cited in study report): Diethanolisopropanolamine (DEIPA)
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: 8/7/1975
- Lot/batch No.: Not specified
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified
- Storage condition of test material: Not specified

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
No data

TEST ATMOSPHERE
No data

VEHICLE
- Composition of vehicle (if applicable): No data
- Concentration of test material in vehicle (if applicable): 16.4 mg/L (approx 3060 ppm)
- Justification of choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

TEST ATMOSPHERE (if not tabulated)
No data

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 7 h

Concentrations:

16.4 mg/L of air or approximately 3060 ppm

No. of animals per sex per dose:

6 males

Control animals:

not specified

Details on study design:

No data

Statistics:

None reported

Results and discussion

Preliminary study:

None reported

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 16.4 mg/L air

Based on:

test mat.

Exp. duration:

7 h

Remarks on result:

other: 95% confidence levels not applicable since no deaths occurred

Mortality:

No deaths occured

Clinical signs:

other: None reported

Body weight:

None reported

Gross pathology:

None reported

Other findings:

All animals exhibited eye and nasal irritation which subsided 24 hours after exposure

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute inhalation study, no deaths were seen following exposure of 6 males rats to DEIPA saturated air (16.4 mg/L) for 7 hours. An acute inhalaiton LC50 of greater than 16.4 mg/L can be determined.

Executive summary:

In a poorly-reported acute inhalation toxicity study, 6 male rats were exposed to DEIPA saturated air (16.4 mg/L) for 7 hours at room temperature.

No mortality occurred. However, all animals exhibited eye and nasal irritation which had subsided 24-hr after exposure. From the results of this study, an LC50 of greater than 16.4 mg/L for DEIPA in rats can be determined.

Critical details were missing on the test substance identifty (e.g. purity/impurity profile), test methods (including species, number of animals, concentration used, level of examination) and results. Therefore, the findings of this early study should be interpreted with caution.