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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
old study report with limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
2074

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
1981
GLP compliance:
no
Test type:
traditional method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
EC Number:
220-482-8
EC Name:
Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
Cas Number:
2781-11-5
Molecular formula:
C9H22NO5P
IUPAC Name:
diethyl {[bis(2-hydroxyethyl)amino]methyl}phosphonate
Test material form:
liquid
Specific details on test material used for the study:
- Color: yellow-brown
- Form: liquid
- Relative density: 1.164 (at 20°C)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeder Winkelmann, Borchen, Germany
- Weight at study initiation: 160-180 g
- Housing: 5 animals of same sex per cage in makrolon cages (type III)
- Diet: "Altromin-R-Standardkost" ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating aerosols: The test substance was mixed with a solution of alcohol-Lutrol (1:1) containing oil red and sprayed in the inhalation chambers.

TEST ATMOSPHERE
- Brief description of analytical method used: Spray mist from the inhalation chamber was absorbed with cotton wool and oil red was extracted with Xylol. The concentration of the test substance in the air was indirectly measured by the extinction of the red coloured solution at 525 nm (the amount of oil red/L air equals the amount of test substance).
- Samples taken from breathing zone: yes
Duration of exposure:
>= 1 - <= 4 h
Remarks on duration:
Exposure for 1 or 4 h
Concentrations:
524 mg/m^3 for 1 h exposure
243 and 520 mg/m^3 for 4 h exposure
No. of animals per sex per dose:
10 males and 10 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: no
Statistics:
LC50 was calculated via probit analysis

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 524 mg/m³ air
Based on:
test mat.
Exp. duration:
1 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 520 mg/m³ air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs were observed during the study period.
Body weight:
Body weight was not examined during the study period.
Gross pathology:
Gross pathology was not performed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute inhalation toxicity study conducted similarly to the OECD TG 403, groups of Wistar rats (10/sex) were exposed by inhalation route to the test material mixed with a solution of alcohol-Lutrol (1:1) for 1 or 4 hours to whole body at concentrations of 524 mg/m3 (1-hour exposure), 243 or 520 mg/m3 (4-hour exposure). Animals were then observed for 7 days.


 


No mortality occurred during the study period. No clinical signs were observed.


 


Combined Inhalation LC50 > 524 mg/m3 (1-hour exposure).


Combined Inhalation LC50 > 520 mg/m3 (4-hour exposure).


 


Under the test conditions, the test material is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.