Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-aminoethylamino)ethanol
EC Number:
203-867-5
EC Name:
2-(2-aminoethylamino)ethanol
Cas Number:
111-41-1
Molecular formula:
C4H12N2O
IUPAC Name:
2-[(2-aminoethyl)amino]ethanol
Test material form:
not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: D R. K . Thomae GMBH, D-7950 Biberach, FRG
- Weight at study initiation: males: between 181 - 191 g; females: between 169-179 g
- Fasting period before study: 16 hours before adminitration, but water was available ad libitum.
- Housing: Steenless wire mesh cages Type DK-III (Becker & co. Castrop-Rauxel, FRG ) housed in fully airconditioned rooms.
- Diet: Labordiaet, fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water : Tap water ad libium per day
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature : 20 -24°C
- Humidity: 30-70%
- Photoperiod: 12 Hours dark/ 12 hours light

IN-LIFE DATES: From: 22 Oct 1985 To: 26 Nov 1985

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Aqua Dest.
Details on oral exposure:
DOSAGE PREPARATION:
Administration volume: 10 mL/kg
Time of day of administration: In the morning
Doses:
1470, 2150, 3160, 5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: recording of signs and symptoms, several times on the day of administration, at least once every workday. Check for mordibund and dead animals twice each workday and once on holidays .
- Weighing of the animals: at the beginning of the test and day 3, 5, 7 and 13.
- Necropsy of survivors performed: yes, gross pathological examination performed.
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 150 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 470 mg/kg bw
Based on:
test mat.
Mortality:
Females: at 3160 and 5000 mg/kg bw all females died within 1 day. At 2150 mg/kg bw one female died during the first day after dosing. No mortality was observed at a concentration of 1470 mg/kg bw.
Males: At 3160 and 5000 mg/kg bw all males died within 1 day. At 2150 mg/kg bw 3 males died during the first day after exposure observation period of 14 days. No mortality was observed at a concentration of 1470 mg/kg bw.
Clinical signs:
For both male and female rat, several clinical signs were observed at a concentration of 2150, 3160 and 5000 mg/kg bw during the first day after administration. The severe clinical signs observed were dyspnea, apathy, stagering, piloerection and poor general state. One day after dosing the clinical signs disappeared.( see table in "attached documents")
At a concentration of 1470 no clinical signs were observed for both male and female rat.

Body weight:
The mean body weight at the start of the test:
- Males: 181 - 191 (g)
- Females: 169-179 (g)
The mean body weight measured during the observation period were comparable for 1470 and 2150 mg/kg bw.
Gross pathology:
Animals that died during the observation period: Dilated stomach with red contents. Mucosa of the small intestine deep-red, atonic with red liquid contents. At a concentration of 5000 mg/kg bw hemorrhagic gastritis was observed.
Sacrificed animals at the end of the test: No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In an acute oral study with rats, performed similar to OECD guideline 423 an LD50 Female > 2150 mg/kg bw and an LD50 males> 1470 mg/kg bw was determined.
Executive summary:

An acute toxicity study was performed similar to OECDguideline 423. Aminoethylethanolamin was administrated by oral gavage to five female rats and five male rats at 1470, 2150, 3160 and 5000 mg/kg body weight. At the two highest concentrations, all males and females died within 24 hours after dosing. At a concentration of 2150 mg/kg dw 3 male rats and 1 female rat died the first day after dosing. At a concentration of 1470 mg/kg bw no mortality occurred. The aminals that died during the test period showed a dilated stomach and deep red mucosa of the small intestines. At a concentation of 5000 mg/kg dw hemorrhagic gastritis was observed. No abnormalities were observed for the sacrificed animals at the end of the test. Based on these results, an LD50> 1470 mg/kg body weight was determined and Aminoethylethanolamin is classified catogory 4 for acute toxicity according to Regulation (EC) No 1272/2008.

Categories Display