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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 April 1991 to 24 April 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
2-({2-[(2-hydroxy-2-phenylethyl)({2-[(2-hydroxy-2-phenylethyl)amino]ethyl})amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)[2-(octadecylamino)ethyl]amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)amino]ethyl}[2-(octadecylamino)ethyl]amino)-1-phenylethan-1-ol; 2-{[2-({2-[bis(2-hydroxy-2-phenylethyl)amino]ethyl}(2-hydroxy-2-phenylethyl)amino)ethyl](octadecyl)amino}-1-phenylethan-1-ol
EC Number:
807-655-9
Cas Number:
1629160-48-0
Molecular formula:
Not available - UVCB substance
IUPAC Name:
2-({2-[(2-hydroxy-2-phenylethyl)({2-[(2-hydroxy-2-phenylethyl)amino]ethyl})amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)[2-(octadecylamino)ethyl]amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)amino]ethyl}[2-(octadecylamino)ethyl]amino)-1-phenylethan-1-ol; 2-{[2-({2-[bis(2-hydroxy-2-phenylethyl)amino]ethyl}(2-hydroxy-2-phenylethyl)amino)ethyl](octadecyl)amino}-1-phenylethan-1-ol
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Identification: FAT 92267/A.
- Description: paste.
- Batch number: EN 3.86
- Purity: 81.1%
- Stability of test article dilution: Stable for at least 2 hours in water.
- Storage conditions: In the dark at room temperature.
- Safety Precautions: Gloves, goggles and face mask were sufficient to assure personnel health and safety.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
EN 3.86

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at room temperature
- Stability under storage conditions: stable for at least 2 hours in water
- Stability under test conditions: unknown

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: Males: 8 weeks and females: 10 weeks
- Weight at study initiation: Males: 182-209 g and females: 173-182 g
- Fasting period before study: Fasted for 16 to 22 hours before gavage.
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding.
- Diet: Pelleted standard Kliba 343, Batch 83/91 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: Community tap water from Füllinsdorf, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination.
- Identification: By unique cage number and corresponding color-coded spots on the tail.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): Air conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light / 12 hours dark and music during the light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
The animals received a single dose of the test article on a mg/kg body weight base by oral gavage after being fasted for 16 to 22 hours (access to water was not interrupted). Food was again presented approximately 3 hours after dosing. Application Volume: 10 ml at 2000 mg/kg.
Rationale: The oral administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article.
Doses:
2000 mg/kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Observations mortality/ Viability: Four times during test day 1 and daily during days 2-15
- Observations body weight: Test days 1 (pre-administartion), 8 and 15.
- Necropsy of survivors performed: yes. All animals were euthanized by intraperitoneal injection of sodium pentobarbitone.
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
The LOGIT-Model could not be applied to the observed rates and death. The toxicity was estimated without use of a statistical model.

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 were observed.
Clinical signs:
other: There were no clinical signs were observed except sedated, hunched posture, ruffled fur in one male animal on day one.
Gross pathology:
No obvious macroscopical organ findings noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of FAT 92267/A in rats of both sexes was estimated to be greater than 2000 mg/kg.
Executive summary:

The acute oral toxicity study was carried out to assess the toxicological profile of FAT 92267/A when administered to rats by single oral gavage, with an observation period of 15 days according to OECD Guidelines 401 and EU method B.1. The experiment was done on five males and 5 females rats. The test article FAT 92267/A was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg. There were no mortality found. There were no clinical signs were observed except sedated, hunched posture, ruffled fur in one male animal on day one. The body weight gain of the animals was not affected by the test article treatment throughout the entire study period. There were no obvious macroscopical organ findings noted. Based on the study results, the acute oral median lethal dose (LD50) of FAT 92267/A in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg.