Registration Dossier

Diss Factsheets

Administrative data

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.