Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate

Endpoint summary

Description of key information

LD50 = 500 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

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

In the key study, the acute oral toxicity of the test item was assessed according to OECD guideline 423.

The starting dose was selected on the basis of the available information about the test item. The LD50 value > 200 – 2000 mg/kg bw according to safety data sheet.

The acute toxic class method was carried out involving a stepwise procedure with the use of 300 mg/kg bw as the starting dose in three female rats. No animals died in first step, so further three female rats were treated with the same dose. No animals died in second step, too, so further three female rats were treated with higher (2000 mg/kg bw) dose. All animals died in third step.

Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out in animals died on Day 1, as well as 15th day after the treatment in survivor animals.

No death occurred at 300 mg/kg bw single oral dose of the test item. All female rats in step 1 and step 2 survived until the end of the 14-day observation period. All rats dosed at 2000 mg/kg bw died on Day 1.

In first step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal.

In second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal.

In third step, CNS - and emotion symptoms (decreased activity, closed eyes, tremor, vocalisation), disturbance of coordination (abnormal gait), decreased righting reflex, decreased muscular - body - tone and a disturbances of the autonomic functions (diarrhea, piloerection) were observed in animals between treatment day (from second hours) and Day 1.

The body weight development was undisturbed in all surviving animals.

All animals treated with 300 mg/kg bw dose survived until the scheduled autopsy on Day 15. All organs of the animals treated with 300 mg/kg bw proved to be free of treatment related gross pathological changes.

All animals treated with 2000 mg/kg bw dose died spontaneously during the study and were necropsied on Day 1. External (anus contaminated with faeces, blood around the nose) and internal necropsy findings (stomach and intestines were full of discharge, blushed mucous membrane in the stomach, haemorrhages on the cardia, sanguine intestinal wall) found in animals of group 3 were connected with test item toxic effect.

The estimated LD50 value is 500 mg/kg bw on basis of LD50 cut off mg/kg bw, because three animals died in 2000 mg/kg bw at third step.

An older study was available on the acute oral toxicity of the test item in the Sprague-Dawley strain rat following OECD guideline 401 (1981). No data on the composition of the test material used in the study is available. Following a range-finding study, a group of 10 fasted animals (5/sex) was given a single oral dose of test item, as a suspension in arachis oil at a dose level of 200 mg/kg bw. The animals were observed for 14 days after the day of dosing and were then killed for gross pathological examination.

All animals showed expected gain in bodyweight during the study, there were no deaths, no signs of systemic toxicity were noted and no abnormalities were noted during the necropsy. The acute oral median lethal dose (LD50) of the test item in the Sprague-Dawley strain rat was found to be greater than 200 mg/kg bw but less than 2000 mg/kg bw.

Justification for classification or non-classification

Based on an acute oral LD50 value of 500 mg/kg bw in rat, the test item is classified for acute toxicity in category 4 (H302: Harmful if swallowed) within the CLP Regulation (EC 1272/2008).