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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


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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The administrations were performed in a single dose by oral route using a stainless steel round-shaped probe fitted to a 1 mL glass syringe.
The specific gravity of the test substance of 0.95 was taken into account.
Doses:
2000 and 5000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
other: historical laboratory data
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signes: after administration and at least once a day thereafter; mortality: twice daily; body weight:
just before administration and then on day 5, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, after opening the thoracic and abdominal cavities,

After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs was performed:
digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities.

In the presence of macroscopic lesions, organ samples will be taken and histological examination will be performed.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 480 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred at the dose levels of 2000 and 5000 mg/kg during the observation period.
Clinical signs:
No clinical signs were observed in the animals treated at the dose level of 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.
Body weight:
The body weight gain of the animals was normal at 2000 mg/kg and of the females at 5000 mg/kg. A slight slowed down of the body weight gain was
noted between day 1 and day 5 in the males at 5000 mg/kg.
Gross pathology:
Due to the absence of macroscopic lesions, no organ samples were taken and no histological examination was performed.
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 “partially unsaturated TEA-Esterquat” was determined to be > 5000 mg/kg bw (nominal).
Executive summary:

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 480 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:
experimental study
Adequacy of study:
key study
Study period:
2004-06-02 to 2004-06-24
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:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CD, Crl. CD
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm, approx 10 % of body surface
- % coverage: no data
- Type of wrap if used: The test item suspension was applied to 8 layers of gauze. The gauze was covered with a plastic sheet and secured with
adhesive plaster on the application site.

The test substance was administrated dermal, on the shaved intact dorsal skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period no residual test item had to be removed

TEST MATERIAL
The test substance was suspended in aqua ad injectabilia
Administrated volume: 10 mL/kg bw
Dose level: 2000 mg/kg bw

VEHICLE
aqua ad injectabilia
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hrs
after administration, thereafter at least once daily.
Individual body weights were recorded before administration of the test substance and thereafter in weekly intervals up to the end of the study.
During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central
nervous system and somatomotor activity as well as behavior pattern were observed at least once a day until all symptoms subsided, thereafter
each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma.
- Necropsy of survivors performed: All surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes
were recorded. No histopathology was carried out as no macroscopic findings were noted at necropsy.

other: skin irritation was scored according to the Draize scheme.
Statistics:
N/A
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
no animal died
Clinical signs:
no signs of toxicity were observed
Body weight:
Normal weight gain was observed, except for one female rat. Its body weight gain appeared to be slightly reduced.
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
Conclusions:
On the basis of the results obtained after a single dermal administration, the dermal LD50 of the test article "partially unsaturated TEA-Esterquat" was determined to be > 2000 mg/kg bw. No animal died. No clinical signs or gross pathological findings were observed. Normal weight gain was observed, except for one female rat. Its body weight gain appeared to be slightly reduced.

Executive summary:

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 for14 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.

 

 

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

Additional information

Acute oral toxicity


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.


 


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.