Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-06-03 to 2011-06-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
CAS name: 1,4-Cyclohexanedicarboxamide, N1,N1,N4,N4-tetrakis(2-hydroxyethyl)-, trans
Chemical characterization: Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide
Characteristics: Whitish, solid, powder, hydroscopic
Contents:
91.53 % Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide

Test animals

Species:
rat
Strain:
other: Rattus norvegicus CD / Crl: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Source: Charles River Deutschland, Sulzfeld
- Strain: Rattus norvegicus CD / Crl: CD(SD)
- approx. 8 weeks
- body weight: 171 - 176 g
- Fasting period before study: 16 hours
- Diet: ad libitum, ssniff R/M-H V 1534
- Water: ad libitum
- Acclimatisation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 55% +/- 15 %
- Illumination: 12 hours artifical fluorescent light and 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.8% aqueous hydroxypropylmethylcellulose
Details on oral exposure:
ADMINISTRATION: 
- Frequency: single dosage on day 1
- Dose volume: 10 ml/kg b.w.
- Dose: 2000 mg/kg/bw
- DOSAGE PREPARATION: the substance was suspended to the appropriate concentration in 0.8% aqueous hydroxypropylmethylcellulose .
The administration volume was 10 mL/kg b.w.
- CLASS METHOD: acute-toxic-class methode
first step 3 female rats are treated with 2000 mg/kg b.w., no signs of toxicity were observed
second step (after 24 h) 3 female rats are treated with 2000 mg/kg b.w.
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: before administration, immediatly, 5, 10, 30 and 60 min, 3, 6 and 24 h after administration and at least once daily
thereafter, until day 14
- Body weight: days 0 (pre-administration) 7 and 14
- Necropsy: All survived animals were necropsied at the end of the observation period
Statistics:
not required

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalitiy occurred.
Clinical signs:
No signs of toxicity.
Body weight:
No apparent changes were found in body weight.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
According to the EC Regulation 1272/2008 and subsequent regulationson classification, labelling and packaging of substances and mixtures, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide is n o n - t o x i c if swallowed.
Executive summary:

The test item is given to female rats by oral administration to obtain information on the toxicity, in particular, lethality of a test item

Under the present test conditions, a single oral administration of 2000 mg trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide/kg b.w. to female rats did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected body weight.

No pathological changes were observed at necropsy.

Therefore, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide is n o n - t o x i c if swallowed.