2-(2-aminoethoxy)ethanol

Endpoint summary

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.