Registration Dossier

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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (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
Chemical structure
Reference substance name:
2,2'-Iminodiethanol, propoxylated
EC Number:
500-085-9
EC Name:
2,2'-Iminodiethanol, propoxylated
Cas Number:
35176-06-8
Molecular formula:
C4H11O2N(C3H6O)n; n = 1 – 6.5
IUPAC Name:
2,2'-Iminodiethanol, propoxylated
Constituent 2
Reference substance name:
500-06-8
IUPAC Name:
500-06-8
Details on test material:
- Physical state: liqiud
- Content: > 99%
- Molar mass: 320 g/mol
- Stability under test conditions: the analytical data verify that the test item formulations are stable at room temperature for at least 2 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan GmbH, Horst, Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 152 - 173 g
- Housing: Groups of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol 400
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 animals per group
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
None
Body weight:
There were no toxicologically significant effects on body weight or body weight gain.
Gross pathology:
No particular findings

Applicant's summary and conclusion

Conclusions:
According to OECD guideline 423 the LD50 cut off is >= 5000 mg/kg bw. According to UN GHS the test item is unclassified. So itis regarded as non-toxic.
Executive summary:

The acute oral median lethal dose (LD50) of the test material in the female Wistar rat was > 2000 mg/kg bw with regard to a study according to OECD TG 423. A dose of 2000 mg/kg bw was tolerated without mortalities, clinic signs, effects on weight gain and gross pathological findings.