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Description of key information

Acute Toxicity:
- LD50 (oral, rat) = 3400kg/kg bw (BASF, 1969)
- LC50 (inhalation, rat) > 8,7 mg/m3(BASF, 1969)
- LD50 (dermal, rabbit) > 3000 mg/kg bw (Huntsman, 1991)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
10 animals per dose, 7 days post-exposure observation
Principles of method if other than guideline:
BASF-test, see details in remarks on material and methods.
GLP compliance:
no
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2 Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 186 - 280 g (mean); female: 166 - 218 g (mean)
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 %, 20 % and 30 %.

Doses:
200, 1600, 2000, 2500, 3200, 4000, 5000, 6400 µl/kg bw = 212, 1696, 2120, 2650, 3392, 4240, 5300, 6784 mg/kg bw (conversation is based on the density of 1.06 g/cm3).
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: several times on the day of application and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 3 400 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 3 700 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 3 000 mg/kg bw
Mortality:
See details in remarks on results.
Clinical signs:
other: Staggering, abdomial position, apathy, irregular respiration, shallow flanks, closed eyes, ruffled fur.
Gross pathology:
2120 - 6784 mg/kg bw: gastrorrhagia, sagged gastrointestinal tract, serous smeared snouts.

Mortality

 Dose (mg/kg bw)  Conc. (%) Gender  1 h  24 h  48 h  8 days                
6784  30 male 0/10 10/10 10/10 10/10                  
6784   30 female 0/10 10/10 10/10 10/10                  
5300  30 male 0/10 0/10 8/10 8/10                
4240  30 male 0/10 0/10 8/10 8/10                
3392  30 male 0/10 3/10 3/10 3/10                  
3392   30 female  0/10 8/10 8/10 8/10                
2650   20 female 0/10 0/10 3/10 3/10                  
2120  20 female 0/10 0/10 1/10 1/10                  
 1696  20 male 0/10 0/10 0/10 0/10                  
 1696  20 female 0/10 0/10 0/10 0/10                  
 212  2 male 0/10 0/10 0/10 0/10                  
 212  2 female 0/10 0/10 0/10 0/10                  

The test substance caused systemic toxicity (including mortality) in a dose dependent manner.

Interpretation of results:
GHS criteria not met
Conclusions:
oral LD50 ca. 3400 mg/kg (male/female)
Executive summary:

In a study comparable to OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 3400 mg/kg body weight. Doses of 212, 1696, 2120, 2650, 3392, 4240, 5300, and 6784 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 7 days. Main clinical signs observed were staggering, apathy, irregular respiration, shallow flanks, abdomial position, closed eyes, ruffled fur. At necropsy, gastrorrhagia, sagged gastrointestinal tract and serous smeared snouts were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 400 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Mar 1969 - 19 Mar 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Inhalation-Risk-Test: BASF-test, see details in remarks on material and methods
GLP compliance:
no
Test type:
standard acute method
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aminodiglykol, 2-(2-Hydroxyaethoxy-)aethylamin
- Physical state: liquid
- Analytical purity: > 99 %
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 157 g (mean)
Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
In the raw data no substance loss but an increase in substance weight was recorded.
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: several times on the day of exposure and daily thereafter
- Frequency of weighing: day 0 and day 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 8.7 mg/m³ air (nominal)
Exp. duration:
8 h
Remarks on result:
other: no mortality occured within 8h; calculation based on the saturated vapor concentration
Mortality:
No mortality occured.
Clinical signs:
other: No symptoms observed.
Body weight:
The animals gained weight.
Gross pathology:
2x bronchitis

The inhalation of a highly saturated vapour-air mixture for 8 h caused no mortality.

Calculation of the saturated vapor concenration is basd on the vapor pressure at 25°C = 0.002 hPa and the molecular weight = 105.14 g/mol which equals a sat. vapor conc. = 0.0087 mg/L = 8.7 mg/m³.

Interpretation of results:
GHS criteria not met
Conclusions:
LC50 > 8.7 mg/m3
Executive summary:

The inhalation of a saturated vapor-air mixture for 8 hours caused no mortality in the inhalation risk test. No clinical signs or indications at necropsy were observed.


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 8.7 mg/m³ air
Physical form:
inhalation: vapour

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
12 May 1981
Deviations:
yes
Remarks:
purity not reported
Qualifier:
according to guideline
Guideline:
other: EPA Federal Register, Vol. 50 188
Version / remarks:
27 September 1985
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6398-21-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: 90-013
- Stability under test conditions: no apparent change in the physical characteristics of the test article during administration
- Storage condition of test material: no data
- Other: gravity: 1.06g/ml; pH=12 (litmus paper)
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey
- Age at study initiation: young adult
- Weight at study initiation: 2.119-2.764 kg
- Housing:Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council
- Diet (e.g. ad libitum): Purina Rabbit Ration H.F., ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h dark/12h light
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of trunk (clipped free of fur)
- Type of wrap if used: rubber dam and an elastic bandage


REMOVAL OF TEST SUBSTANCE: no data


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg
- Constant volume or concentration used: YES


Duration of exposure:
24h
Doses:
3000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation daily through 14d, body weight recorded at d0, d7 and d14
- Necropsy of survivors performed: YES
- Other examinations performed: clinical signs, body weight
Statistics:
Not applicable.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
3 000 mg/kg bw
Mortality:
No mortality observed during study.
Clinical signs:
other: Days 1 and 2: 10/10 animals:decreased activity, abnormal stance& gait. Days 3 up to 14 no signs in all observed animals. Day 1: 1/10 animal:diarrhea. Days 3 up to 14 no signs in all observed animals. Day 2: 10/10 animals poor grooming. Days 3 up to 14 no
Gross pathology:
Terminal necropsy of the animals revealed severe irritation and/or yellow discoloration of the underlying muscle tissue at the application site, necrotic or discolored yellow fascia at the application site, mottled lungs and pale kidneys.
Other findings:
no other data
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 3000mg/kg.
Executive summary:

In a Limit Test, one group of 10 rabbits (5 males and 5 females) was dermally administered the test article at 3000 mg/kg. Clinical signs observed during the study included decreased activity, abnormal stance, abnormal gait, diarrhea, poor groo of fur surrounding the application site were observed. Necrosis and sloughing of the skin at application site, bilateral alopecia and a clear exudate from necrotic areas were also observed during the study. Terminal necropsy of the animals revealed severe irritation and/or yellow discoloration of the underlying muscle tissue at the application site, necrotic or discolored yellow fascia at the application site, mottled lungs and pale kidneys. Based on the observation made in the Acute Exposure Dermal Toxicity Study in rabbits, the estimated acute dermal LD50 was determined to be greater than 3000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 3 000 mg/kg bw

Additional information

Oral:


In a study which was in large parts equivalent to methods described in OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 3400 mg/kg body weight (BASF, 1969). Doses of 212, 1696, 2120, 2650, 3392, 4240, 5300, and 6784 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 7 days. Main clinical signs observed were staggering, apathy, irregular respiration, shallow flanks, abdomial position, closed eyes, ruffled fur. At necropsy, gastrorrhagia, sagged gastrointestinal tract and serous smeared snouts were observed. In two supporting studies with only limited data provided, the test substance caused likewise low toxicity after a single ingestion (LD50 = 2558 mg/kg bw; Huntsman 1991, LD50=5660 mg/kg bw; Smyth et al., 1951).


 


Inhalation:


The inhalation of a saturated vapor-air mixture for 8 hours caused no mortality in two inhalation risk tests. No clinical signs or indications at necropsy were observed (BASF, 1969; Smyth et al., 1951).


 


Dermal:


In the Key study an LD50 > 3000 mg/kg bw was reported (Huntsman, 1991). In the available limit-test as secondary source the acute dermal toxicity of 2-(2-aminoethoxy)ethanol was evaluated in rats according to OECD guideline 402 and in compliance with GLP. No mortalities were observed at the highest test dose level of 3000 mg/kg bw. Observations noted on live animals included decreased activity, poor grooming, diarrhoea, abnormal gait and stance and dyspnoea. A clear mucous anal discharge and a yellow discolouration of fur, with necrosis and skin sloughing surrounding the application site were observed. Terminal necropsy of animals revealed severe irritation and/or yellow discolouration of the underlying muscle tissue at the application site and also necrotic or discoloured fascia. Mottled lungs and pale kidneys were observed.


A dermal LD50 value of 1190 µl/kg bw, equivalent to 1260 mg/kg bw was published in a study for rabbits, with no further details provided (Smyth et al., 1966).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.