2,2',2''-nitrilotriethanol

Endpoint summary

Description of key information

Acute toxicity data indicate low toxicity: in rats the oral LD50 was 6400 mg/kg bw; in rabbits the dermal LD50 was > 2000 mg/kg bw. Inhalation exposure for 8 hours to vapour saturated with TEA failed to cause any deaths in rats (LC50 was not determined).

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:

28.11.1965-04.01.1966

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

The acute oral toxicitiy of the test substance was assessed in rats.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 % (200 ccm/kg) and 20 % (all other dose levels) (v/v)
- Justification for choice of vehicle: test substance is readily soluble in water

Doses:

200, 1600, 3200, 4000, 5000, 6400 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: 7 days
- Frequency of observations and weighing: daily on working days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

6 400 mg/kg bw

Mortality:

6400 mg/kg bw dosing group: 5/10 animals (2 males, 3 females) within 24 hours
no further deaths recorded

Clinical signs:

other: 200 mg/kg bw dosing group: slight agitation up to 4 hours following treatment other dosing groups: unsteady, elevated respiration; anancasm to chew; apathy lasting for 1 or 2 days; reduced grooming; All animals were without findings two days after dosing

Gross pathology:

Organs without findings

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 400 mg/kg bw

Quality of whole database:

similar to OECD TG 401

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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:

date of report: July 30, 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TEA from NH3: jefferson 50303 and TEA from DEA: 2H1763
- Impurities: both test substances contain DEA as a major impurity of about 6.5 %, the DEA derived test substance additionally includes TEA-1EO at 4.4 %

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

intact and abraded skin was tested

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals tested with intact skin and 3 animals tested with abraded skin with DEA-derived and NH3-derived TEA each (12 animals in total)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight

Key result

Sex:

not specified

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Mortality:

TEA derived from NH3 (intact): 0/3
TEA derived from NH3 (abraded): 0/3
TEA derived from DEA (intact): 0/3
TEA derived from DEA (abraded): 0/3

Clinical signs:

other: TEA derived from NH3: mild erythema at 24 hrs (intact and abraded skin) returning to normal on day 6 TEA derived from DEA: moderate erythema at 24 hrs (intact and abraded skin) returning to normal on day 10

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

similar to OECD TG 402

Additional information

Oral toxicity

In an acute oral toxicity study (BASF AG, 1966), 5 Sprague-Dawley rats/sex/dose were exposed to 200 - 6400 mg/kg bw TEA by gavage and observed for 7 days. The LD50 was determined to be 6400 mg/kg bw for males and females. No deaths occurred at doses of 5000 mg/kg bw or below. At 200 mg/kg bw, slight agitation was observed up to 4 hours after exposure; at higher doses unsteady, elevated respiration, anancasm to chew, apathy, and reduced grooming was noticed. Two days after exposure, no clinical signs were observed. Gross pathology did not reveal any abnormalities.

Dermal toxicity

In a dermal limit test, rabbits were treated with 2000 mg/kg bw TEA on the intact or abraded skin and subsequently observed for a 14 -day period (EPA, 1989a). The test substance was either derived from NH3 (92% TEA) or DEA (88% TEA), both containing approximately 6.5% DEA. Mild erythema was observed following exposure to TEA derived from NH3 on the intact or abraded skin, returning to normal on day 6. Moderate erythema was observed following exposure to TEA derived from DEA on the intact or abraded skin, returning to normal on day 10. No mortality was observed, hence the LD50 was > 2000 mg/kg bw.

Inhalation toxicity

Due to its extremely low volatility, there is a lack of data documenting the acute inhalation toxicity. As good quality data for the oral and dermal route are available, in accordance with column 2 of REACH Annex VIII, a study regarding the inhalation route is not required. One limited report stated that whole-body exposure of rats to a saturated TEA atmosphere (approximately 1.8 mg/m3) at 20°C for 8 hours failed to cause any deaths. Therefore no LC50 value has been determined for this compound (BASF AG, 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 (EC) No 1272/2008. Based on available data on acute oral and dermal toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.