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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of 2,2',2''-nitrilotriethanol and 2,2'-[[2-[(2-hydroxyethyl)amino]ethyl]imino]bisethanol and 2,2'-iminodiethanol.
IUPAC Name:
Reaction mass of 2,2',2''-nitrilotriethanol and 2,2'-[[2-[(2-hydroxyethyl)amino]ethyl]imino]bisethanol and 2,2'-iminodiethanol.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8- 12 weeks
- Weight at study initiation: males weighed 216 to 235g, and the females 202 to 216g
- Fasting period before study: over night
- Housing: 3- 6 in solid -floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19- 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 female and 3 male
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities
Clinical signs:
other: No clinical signs of systemic toxicity
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not harmful after oral administration. Oral LD50 is < 2000 mg/kg
Executive summary:

In an acute oral toxicity study in the rat according to the acute toxic class method, Sprague Dawley rats were dosed with 2000 mg/kg bw via gavage. There were no mortalities and no clinical signs of toxicity. Body weight gain was as expected and no abnormalities were noted on necropsy.