2-ethylaminoethanol

Endpoint summary

Description of key information

Acute oral toxicity studies have been performed in the rat and mouse; a supporting read-across study in the rat is also available.  Dermal toxicity studies in the rat and rabbit are available.  Two studies of acute inhalation toxicity in the rat are available.

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

Study period:

1 February 1978 to 14 March 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline-comparabale, non-GLP proprietary study containing limited information but adequate for the purposes of hazard identification and classification.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Internal method comparable to OECD 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no information
- Age at study initiation:
- Weight at study initiation: males approximately 250 g (group mean) and females 180 g (group mean)
- Fasting period before study: 15-20 h


IN-LIFE DATES: From: 1 February 1978 To: 14 March 1978

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6.81; 10.00 and 14.70 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: distilled water
-

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

681, 1000 and 1470 mg/kg bw

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1-4, 7 and day 13
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight

Statistics:

median lethal dose for combined sexes obtained by interpolation method

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 073 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Calculated by the interpolation method

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 470 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 100% mortality at 1470 mg/kg bw; 30% mortality at 1000 mg/kg bw

Sex:

male

Dose descriptor:

LD50

Effect level:

> 1 000 - < 1 470 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 100% mortality at 1470 mg/kg bw; 0% mortality at 1000 mg/kg bw

Sex:

female

Dose descriptor:

LD50

Effect level:

> 681 - < 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 60% mortality at 1000 mg/kg bw; 0% mortality at 681 mg/kg bw

Mortality:

All five males dosed at 1470 mg/kg died between day 1 and day 7 (3 died on Day 1). No male mortalities occurred at the lower two dose levels (1000 and 681 mg/kg ) . All five females dosed at 1470 mg/kg died between day 1 and day 7 (4 died on day 1). No female mortalities occurred at the lowest dose levels (681 mg/kg ) but three females died on day 7 after dosing at 1000 mg/kg.

Clinical signs:

other: Rats dosed at 1470 mg/kg showed clinical signs including apathy, yellow discoloured urine, dyspnoea, staggering, pilo-erection and poor general condition. No details are provided regarding times of onset or recovery. rats dosed at 1000 mg/kg showed clini

Gross pathology:

No information

The acute oral LD50 in the rat was found to be 1000 -1470 mg/kg bw and was calculated to be 1073 mg/kg bw (combined sexes).

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The overall median lethal oral dose for male and female rats was calculated to be 1073.38 mg/kg bw (Category 4 CLP classification)

Executive summary:

Groups of five male and five female SD rats were dosed by oral gavage at levels of 681, 1000 or 1470 mg/kg bw and observed for 14 days. All rats dosed at 1470 mg/kg by died within 7 days, 3 female rats died at 1000 mg/kg and there were no mortalities in the low dose group. The acute oral LD50 is therefore calculated to be 1073 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 073 mg/kg bw

Quality of whole database:

The key study is a guideline-comparable proprietary study and is supported by the results of a less comprehensively reported screening study in the rat, a mouse study and a supporting study using neutralised material.

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:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP proprietary study, predates OECD guideline, but scientifically fully acceptable and well documented.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Methods of HF Smyth et al An.Ind.Hyg.ASS.J. 23. 95-107 (1962). Rats were exposed to a saturated vapour concentration atmosphere at 2.17 mg/L for seven hours and respiratory tract irritation and mortality monitored. BASF-Test: standard method for acute inhalation toxicity with rats exposed to a saturated atmosphere for 8 h.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no information
- Age at study initiation:no information
- Weight at study initiation: males approximately *** g (group mean) and females *** g (group mean)
- Fasting period before study: not applicable for inhalation route


IN-LIFE DATES: From: February 1978 To: March 1978

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

air

Details on inhalation exposure:

Rats were exposed to a saturated vapour concentration atmosphere of 2.17 mg/L for seven hours and respiratory tract irritation and mortality monitored.
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Water bath, 200 L air/h, 20°C, saturated atmosphere
The vapours were generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

7 h

Concentrations:

2.16 mg/L saturated vapour concentration - saturated vapour concentration

No. of animals per sex per dose:

a group of 12 rats were exposed, no information on sex ratio

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology, body weight (at start of study)

Statistics:

No data

Sex:

not specified

Dose descriptor:

other: maximum achievable dose toleration over an extended exposure period

Effect level:

> 2.17 mg/L air

Based on:

other: exposure to saturated vapour concentration over a 7 h period

Exp. duration:

7 h

Remarks on result:

other: No mortality following a 7-hour exposure to a saturated vapour concentration

Mortality:

No mortality among twelve rats exposed to 2.17 mg/L for 7 hours

Clinical signs:

other: nasal discharge/bloody nose intermittent breathing mild corrosion of the nose unkempt fur unsteady gait

Body weight:

No data

Gross pathology:

No information

Other findings:

No information

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No deaths occurred in a group of twelve rats exposed by inhalation to the saturated vapour concentration of 2.17 mg/L. The animals were exposed for a period of seven hours without serious adverse effect.

Executive summary:

Rats were exposed to a saturated vapour concentration atmosphere at 2.17 mg/L for seven hours and respiratory tract irritation and mortality monitored. No deaths occurred in a group of twelve rats exposed by inhalation to the saturated vapour concentration of 2.17 mg/L. The animals were exposed for a period of seven hours without serious adverse effect. No deaths occurred at the saturated vapour concentration: the acute LC50 is therefore >2.17 mg/L

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

2 170 mg/m³ air

Quality of whole database:

A more modern guideline-comparable rat study is available; an older screening study in the rat is also available but is not considered to be sufficiently reliable for the purposes of classification. The two studies report comparable results.

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

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline comparable, non-GLP proprietray study.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

BASF in-house test methods similar to those subsequently outlined in OECD acute testing guidelines. The study design is similar to standard acute dermal method described in TG OECD 402

GLP compliance:

no

Test type:

other: various acute toxicity investigations presented in a single report

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No information

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No information available

Duration of exposure:

No information available

Doses:

No information

No. of animals per sex per dose:

No information

Control animals:

not specified

Details on study design:

In-house BASF test design, no additional information available. Methods similar to those subsequently adopted for OECD 402

Statistics:

Median lethal dose was calculated by Probit analysis using the method of FInney

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 670 mg/kg bw

Based on:

test mat.

95% CL:

> 3 030 - < 5 180

Mortality:

Mortalities occurred but no details are presented in the report

Clinical signs:

other: Following application vocalising and a'long-legged' gait were noted. The animals were initially aggressive but subsequently apathetic. Persistent necrosis was apparent from 24 h after dosing The only clinical sign observed was apathy

Gross pathology:

- Histopathology (decedent animals): cadaveric
- Histopathology (killed animals): no findings

Other findings:

No information

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The median lethal dose for rats for dermally administered 2-ethylethanolamine was 3670 mg/kg (confidence limit 3030 to 5180 mg/kg)

Executive summary:

The median lethal dermal dose of 2 -ethylethanolamine to rats was calculated following exposure to the unchanged test material. The rats were apathetic after dosing but no other signs of reaction to treatment were observed. After dermal treatment with 2 -ethylaminoethanol the rats showed clinical signs including screaming, aggression and long-legged gait. In the observation period apathy was observed. Further, necrosis was noted which lasted throughout the observation period. A dermal LD 50 of 3670 (3030-5180) mg/kg bw was calculated.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 670 mg/kg bw

Quality of whole database:

A more modern guideline-comparable rat study is available; an older screening study in the rabbit is also available but is not considered to be sufficiently reliable.

Additional information

Acute oral toxicity

The key study for this endpoint (Friesburg, 1979) is guideline-comparable and was performed in the rat; this study reports an LD50 value of 1073 mg/kg bw. The resulst of the key study is supported a comparable acute oral LD50 of 1480 mg/kg bw from a less detailed and older screening study (Smyth et al, 1954). A greater degree of acute oral toxicity (LD50 50 -200 mg/kg bw) is reported in the mouse (Friesburg, 1978); but this species is not preferred for the purposes of classification. A published supporting study performed in the rat but using he neutralised substance reports an oral LD50 of 1020 -1610 mg/kg bw (Hartung & Cornish, 1969).

Acute inhalation toxicity

The key study for this endpoint (Friesburg & Klimisch, 1979) reports no mortality in rats exposed to a saturated vapour concentration (2.17 mg/L) for seven hours. In an older screening study with less complete reporting of the methodology (Smyth et al, 1954), no mortality is reported in rats exposed to a saturated vapour concentration (2.51 mg/L) for eight hours.

Acute dermal toxicity

The key study for this endpoint (Friesburg, 1979) is guideline-comparable and was performed in the rat; this study reports an LD50 value of 3670 mg/kg bw. Local effects and clinical signs in this study are consistent with marked local toxicity.

The results of an older screening study performed in the rabbit are also available (Smyth et al, 1954); however the study is not considered to be sufficiently reliable due to limited reporting of the methodology. The study reports an LD50 value of 0.36 mL/kg bw (equivalent to 329 mg/kg bw).

Justification for selection of acute toxicity – oral endpoint
More modern, guideline-comparable study in the rat.

Justification for selection of acute toxicity – inhalation endpoint
More modern, and reliable guideline-comparable study

Justification for selection of acute toxicity – dermal endpoint
More modern, and reliable guideline-comparable study performed in the rat.

Justification for classification or non-classification

Based on the results of the key acute toxicity studies, 2 -ethylaminoethanol is classified in CLP Category 4 for acute oral toxicity.

No classification is required for acute inhalation or acute dermal toxicity based on the results of the key studies.