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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
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

Constituent 1
Chemical structure
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:
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 remainder of the study.
Body weight:
Transient decrease in body weight on test day 1 in most rats. All rats subsequently gained body weight over the 2-week observation period. .
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).

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