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Toxicological information

Acute Toxicity: inhalation

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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

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: 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.

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