N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate

Endpoint summary

Description of key information

oral: OECD 401, rat LD50 > 200 < 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For the SPECIFIC JUSTIFICATION FOR READ-ACROSS (Source substance: Quarternary Ammonium compounds, tri-C8-C10-alkylmethyl, chlorides, Target substance: Quarternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates) please see attached document under 13.2 "Other assessment reports".

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Species:

rat

Sex:

male/female

Route of administration:

oral: gavage

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no substance related death at 200 mg/kg bw, but all animals died at the highest dose of 2000 mg/kg bw

Mortality:

Neither female nor male animals died in the 200 mg/kg bw test group. Only one male animal had to be killed after 52 hours, but this was due to mistake during gavage. In the 2000 mg/kg bw test group 4 male animals and all female animals died within the first 30 hours after dosing. The additional male animal died 48 hours after application. Thus, mortality was 100% at 2000 mg/kg bw.

Clinical signs:

other: Female animals dosed with 200 mg/kg bw did not show any clinical signs. The one male animal that died due to gavage error showed decreased activity, brownish colored nose, vocalization, diarrhoea, severe reduction of body weight and chromodacryorrhoea but

Gross pathology:

For the animals dosed with 200 mg/kg bw no abnormal findings at gross necropsy were detected. 2 male animals dosed with 2000 mg/kg bw showed a severe gaseous distention of the small intestine and all 5 female animals showed a slight to severe gaseous distention of the small intestine and the stomach. 1 female animal had a red discolored glandular stomach and the duodenum filled with liquid. 2 male animals and all 5 female animals showed a severe hydrothorax, 2 male animals had redness of the fundus area and moderate ascites. 1 male animal had a filled small intestine, slight ascites and a slight hypothorax.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 was
> 200 < 2000 mg/kg bw for male rats and
> 200 < 2000 mg/kg bw for female rats.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

200 mg/kg bw

Quality of whole database:

OECD & EC guideline study, no deviations, GLP

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

No experimental data on acute oral toxicity are available for the target substance Quaternary ammonium compounds, tri-C8-C10-alkylmethyl, Me sulfates. However, a study was performed with the closely related sourde substance Quarternary ammonium compounds, tri-C8 -10 -alkylmethyl, chlorides. A justification for read-across is attached to iuclid section 13.

The test substance Quarternary ammonium compounds, tri-C8 -10 -alkylmethyl, chlorides was administered at concentrations of 200 and 2000 mg/kg bw by gavage to groups each 5 male and female Wistar rats. The observation period of 14 days included daily observations for clinical signs and mortality, and weighing the day before and on the day of application, as well as on days 2, 7 and 14. Necropsy of all animals was performed.

None of the animals exposed to 200 mg/kg bw died up to the end of the 14 day observation period. Only one male animal had to be sacrificed 52 hours post dosing, but this was due to a gavage error. No clinical signs could be observed and all animals showed a normal body weight gain.

4 male animals and all 5 female animals died within 30 hours after application of 2000 mg/kg bw. The fifth male animal died 48 hours after application. Onset of clinical signs was already 15 minutes after dosing for male animals and 2.5 hours for females. Severity of symptoms increased up to death of the animals. Clinical signs included: vocalization, piloerection, diarrhea, decreased activity, squatting posture which changed to belly-side location and belly location at later time points, brownish colored nose and/or snout and lid closure.

Gross pathology revealed no abnormal findings for the animals dosed with 200 mg/kg bw. Animals dosed with 2000 mg/kg bw showed the following pathological findings:

2 male and 5 female animals dosed with 2000 mg/kg bw showed a severe gaseous distention of the small intestine and the females additionally of the stomach. 1 female animal had a red discolored glandular stomach and the duodenum filled with liquid. 2 male animals and all 5 female animals showed a severe hydrothorax, 2 male animals had redness of the fundus area and moderate ascites. Additionally, 1 male animal had a filled small intestine, slight ascites and a slight hypothorax. The effects described, which occurred at the site of contact, could be interpreted as consequence of the corrosive potential of the test substance.

In conclusion, the LD50 was set to be > 200 < 2000 mg/kg bw and therefore also the target substance Quarternary ammonium compounds, tri-C8 -10 -alkylmethyl, me sulfates, needs to be classified as toxic (Cat.3, H301) according to CLP Regulation (EC) No. 1272/2008 (worst case).

Justification for classification or non-classification

Based on the available data obtained with a closely related source substance, the LD50 is >200 and <2000 mg/kg bw. Therefore, Quarternary ammonium compounds, tri-C8 -10 -alkylmethyl, Me sulfates, needs to be classified as toxic if swallowed (Cat.3, H301) according to CLP Regulation (EC) No. 1272/2008 (worst case).