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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Jan to 9 Feb 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OECD guideline study 401 (1987; available at time of study, deleted in 2002) to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

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: Clear liquid

Details on test material:

- Name of test material (as cited in study report): Diethanolisopropanolamine (DEIPA)
- Substance type: Technical product
- Physical state: Liquid
- Analytical purity: 92.9 %
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: Not specified
- Lot/batch No.: 980035B
- 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:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Inc. (Raleigh, NC)
- Age at study initiation: 2 months
- Weight at study initiation: 111-226 g
- Fasting period before study: Fasted the night prior to treatment
- Housing: No data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3oC
- Humidity (%): 40-70%
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Not applicable

Doses:

2000 mg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed at least once per day, weighed pre study and on test days 1, 2, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, eye examinations

Statistics:

Mean and standard deviations calculated for body weights, outliers included.

Results and discussion

Preliminary study:

None

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% confidence level not applicable as no deaths occurred.

Mortality:

All rats survived to the end of the 2-week observation period.

Clinical signs:

other: On test day 1, there was faecal soiling in 3 males and 3 females, watery or soft faeces in 1 male and 2 females and diarrhoea in 1 female. All signs resolved for all animals on test days 2 or 3. No other treatment-related clinical signs observed for the

Gross pathology:

No treatment-related gross pathologic observations.

Other findings:

1 male had a cloudy eye on test day 10 and one female had urine perineal soiling on test day 15. The investigators interpreted these observations to be not treatment-related.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

From the results of this GLP study conducted according to OECD Guideline 401 (1987; available at time of study) an acute oral LD50 of DEIPA in rats was determined to be greater than 2000 mg/kg bw (limit test).

Executive summary:

In a GLP acute oral toxicity study, conducted according to OECD guideline 401 (1987; available at time of study) groups of 5 male and female Fischer 344 rats were administered a single dose of 2000 mg/kg bw of neat DEIPA by gavage. During the two-week observation period the animals were frequently evaluated for weight changes and clinical signs of toxicity. All survivors were examined for gross pathological changes.

 

No mortality occurred over the two-week observation period and very few clinical treatment-related signs were observed. Faecal soiling in 3 males and 3 females, watery or soft faeces in a male and 2 females and diarrhoea in a female were noted on test day 1, which resolved for all animals by test day 3. All rats gained body weight over the 2-week ovservation period following a transient decrease in body weight on test day 1. There were no treatment-related gross pathological observations.

 

From the results of this study, an acute oral LD50 of DEIPA in rats was determined to be greater than 2000 mg/kg bw (limit test).