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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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).