Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (rat, m/f) > 4480 mg a.i./kg bw (EU Method B.1, oral: gavage); RL1; GLP



Dermal LD50 (rat, m/f) > 2000 mg a.i./kg bw (OECD TG 402); RL1; GLP; read-across partially unsaturated TEA-Esterquat

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:
1997-03-14 to 1997-05-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was diluted in bedistilled water. The solutions were prepared immediately before the administration. A single dose was given,
at a volume of 10 mL/kg bw.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
In a preliminary study one female was orally administered to 2000 mg/kg bw test substance and observed for 7 days.

Main study:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least twice a day for clinical sympotmes; body weight: before administration, daily for the first three
days, then weekly and at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
The necropsy included a revision of the intact animal and all its superficial tissues, followed by an observation of the cranial, thoracic and
abdominal cavities both in situ and after evisceration.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: nominal, no animal died
Mortality:
None of the animals treated at the dose of 2000 mg/kg bw died
Clinical signs:
other: No clinical signs were observed in the animals administered at 2000 mg/kg bw
Gross pathology:
In the necropsies carried out, the animals did not present any visible macroscopic lesions related to the treatment. The only observation made was a
dilatation of the right renal pelvis of one of the males.
Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained after a single oral administration, the oral LD50 of the test article “oleic acid-based TEA-Esterquat” was
determined to be > 2000 mg/kg bw. No animal died. No clinical signs, effects on body weight or gross pathological findings were observed.
Executive summary:

In an acute oral toxicity study (according to EU Method B 1, fixed dose procedure), 5 male and 5 female Sprague-Dawley rats were given a single oral doses of 2000 mg/kg bw oleic acid-based TEA-Esterquat and observed for 14 days.


 


Oral LD50 Males and Females > 2000 mg/kg bw (nominal)


 


No animal died. No clinical signs or effects on body weight were observed at 2000 mg/kg bw.


Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings. The only observation made was a dilatation of the right renal pelvis of one male.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because
• they share structural similarities with common functional groups: One quaternised ethanolamine moiety, one to three, mainly two ester groups with a typical UVCB distribution with long-chain fatty acids of natural origin. The molecular structure is almost identical.
• they are manufactured from similar resp. identical precursors (triethanolamine, long-chain fatty acids, dimethyl sulphate) under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident
• A constant pattern in the changing of the potency of the properties across the TEA-Esterquats by chain-length and the grade of esterification is not observed, because the fatty acid chain-length distribution is too narrow and similar and the distribution of mono-, di-, and tri-esters is identical. Some variation caused by variation in C=C double bonds may occur and will be discussed at the relevant endpoint.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See justification for read-across attached to chapter 13 of this IUCLID file.

3. ANALOGUE APPROACH JUSTIFICATION
See justification for read-across attached to chapter 13 of this IUCLID file.

4. DATA MATRIX
See justification for read-across attached to chapter 13 of this IUCLID file.
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across source
Test type:
standard acute method
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animal died
Mortality:
no animal died
Clinical signs:
other: no signs of toxicity were observed
Gross pathology:
No marcroscopical changes were noted at necropsy.
Other findings:
No erythema or oedema were observed. All readings were 0.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

For the assessment of acute toxicity of oleic acid-based TEA-Esterquat an acute oral toxicity study in rat is available; no dermal or inhalation toxicity studies were conducted with teh target substance. However, an acute dermal toxicity study is available for the source substance partially unsaturated TEA-Esterquat. A justification for read-across is attached to Iuclid section 13.


 


Acute oral toxicity


In an acute oral toxicity study (EU Method B.1 bis, Acute Oral Toxicity - Fixed Dose Procedure), 5 male and 5 female Sprague-Dawley rats were given a single oral dose of 2000 mg/kg bw of oleic acid-based TEA-Esterquat and were observed for 14 days.


No animal died. No clinical signs or effects on body weight were observed. Gross pathological examinations at terminal necropsy revealed no test article-dependent findings.


Oleic acid-based TEA-Esterquat is practically non-toxic based on the oral LD50 of > 2000 mg/kg bw (nominal) determined in this study.


 


In an acute oral toxicity study (according to EU Method B.1), 5 Sprague-Dawley rats/sex/dose were given single oral doses of 2000 or 5000 mg/kg bw  of partially unsaturated TEA-Esterquat (89.6 % a.i.) and observed for 14 days.


Oral LD50 Males and Females > 5000 mg/kg bw (nominal)


Oral LD50 Males and Females > 4480 mg/kg bw (based on a.i.)


No animal died. No clinical signs or effects on body weight were observed at 2000 mg/kg bw.


Hypokinesia was noted only in the treated males at the dose level of 5000 mg/kg bw, 30 minutes and one hour after treatment, then in all the animals after 2 and 4 hours. From day 2 to day 15, no clinical signs were observed at the dose level of 5000 mg/kg bw. These findings were accompanied by a slight slowed down of the body weight gain between day 1 and day 5 in the males at 5000 mg/kg bw. Normal weight gain was observed in the female 5000 mg/kg bw group. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.


 


Acute inhalation toxicity


According to REACH regulation, Annex XI, the conduct of an acute inhalation toxicity study is scientifically unjustified. The test substance has a low vapor pressure, so the potential for the unintended generation of inhalable forms such as aerosols is low. The most likely route of human exposure for workers and consumers is the dermal route.


The generation of dusts and aerosols is prevented by appropriate RMMs. Thus, there is no concern with respect to respiratory irritation.


Given that acute toxicity is unlikely to occur based on low acute toxicity via the oral and dermal route, as well as on low exposure levels, testing by the inhalation route is scientifically not necessary according to REACH Regulation Annex XI 1 and 3.


 


Acute dermal toxicity


In an acute dermal toxicity study according to OECD guideline 402, 1987 and EU method B.3, 1992, 5 male and 5 female young adult CD rats were dermally exposed to the partially unsaturated TEA-Esterquat suspended in water for 24 hours under an occlusive dressing to approx. 10 % of body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days.


Dermal LD50          Males > 2000 mg/kg bw


                                  Females > 2000 mg/kg bw


                                 Combined > 2000 mg/kg bw


No mortality occurred in this limit test. No clinical signs were observed. No macroscopical changes were noted at gross pathological examinations at terminal necropsy. Normal weight gain was observed, except for one female rat. Its body weight gain appeared to be slightly reduced.


 


There are no data gaps for the endpoint acute toxicity. No human data are available. However, there is no reason to believe that these results from rat would not be applicable to humans.


 


Supporting data


Similar results were obtained with the source substance MDEA-Esterquat C16-18 and C18 unsatd., which is practically non-toxic based on the oral LD50 of >10.000 mg/kg bw and the dermal LD50 of >2000 mg/kg bw. These data are included into the dossier to demonstrate, that both substances have a similar toxicological profile.

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for acute toxicity according to regulation (EC) 1272/2008. Thus, no labelling is required.