Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-(octylimino)bisethanol
EC Number:
239-555-0
EC Name:
2,2'-(octylimino)bisethanol
Cas Number:
15520-05-5
Molecular formula:
C12H27NO2
IUPAC Name:
2-[(2-hydroxyethyl)(octyl)amino]ethan-1-ol
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
origin of test animals: HOECHST AG, Kastengrund, SPF-breeding
details on species: Wistar-rat / Hoe: WISKf (SPF71)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
test animals female: 800/1250/1600/2000 mg/kg bw
test animals male: 2000 mg/kg bw
No. of animals per sex per dose:
test animals female: 5 animal per dose (800/1250/1600/2000 mg/kg bw)
test animals male: 5 animal per dose (2000 mg/kg bw)
Control animals:
no
Details on study design:
The test item in sesam oil was admistered by gavage in the above mentioned doses. The observation periode after the application was 14 days. The apperance of symthoms and lethality was registered twice a day (forenoon and afternoon), once a day on week-end and on public holidays. During this periode of time the weight of the animals was recorded. The number of animals died during the test peride were anatomized and examined for macroscopic findings..
The number of surviving animals were sacrificed at the end of the observation periode by carbon monoxide. These testing animals were also anatomized and examined for macroscopic findings.
Statistics:
The LD50, the 95% confidence level as well as the equation of the probit straight line were calculated for the femal testing animals by the ratio of lethality via the probit analysis. (Methode according FIELLER and SIDAK, softwar developement: Pharma Forschung and
Entwicklung Informatik der Hoechst AG)

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 157 mg/kg bw
Based on:
test mat.
95% CL:
>= 122 - <= 1 736
Mortality:
male test animals: 3/5 (2000 mg/kg bw dose group)
female test animals: 1/5 (800 mg/kg bw dose group); 3/5 (1250 mg/kg bw dose group); 4/5 (1600 mg/kg bw dose group); 4/5 (2000 mg/kg bw dose group)
Clinical signs:
other: 1157 mg/kg bwObserved by female and male test animals after the application of the test item: 1) reduced spontaneous activity 2) daze feeling 3) crouch 4) long-legged walk 5) uncoordinated/tumbled walk 6) face-down position 7) narrowed palpebral fissure
Gross pathology:
The macroscopic examination of the male/female test animals died during the testing showed ablation of the mucous membrane of the gastrointestinal tract. Furthermore, the small intestine of the female test animals died during the testing was partial reddened and at one female test animal of the 2000 mg/kg bw dose group it was filled with a red, mucous material (blood).

Those animals killed after the observation periode showed no visible macroscopic finding.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 (oral, female rat): 1157 mg/kg body weight
Executive summary:

In order to assess the acute oral toxicity of the test item, an OECD 401 study in rats was performed. Mortality occurred in the male group in 3/5 animals. In the female group mortality occurred in 1/5, 3/5, 4/5 and 4/5 animals of the 800, 1250, 1600 and 2000 mg/kg body weight dose groups, respectively. At higher doses unspecific findings like irregular respiration, irregular movements, narrow palpebral fissure, mydriasis and prone position were observed. All clinical signs were reversible within 2 days after treatment. Body weight development during the course of the study was not affected by the treatment. Necropsy of deceased animals: Partial delamination of gastric lining, reddening of small intestine. All surviving animals which were sacrificed at the end of the 14-day observation period were free of any macroscopic findings.

The median lethal dose of the test substance after single oral administration to male and female rats, observed over a period of 14 days is determined to be: LD50(oral, female rat): 1157 mg/kg body weight .