p,p',p''-tris(dimethylamino)trityl alcohol

Endpoint summary

Description of key information

The acute oral toxicity of test chemical in test animals was observed to be between 300 to 2000 mg/kg body weight. And hence, the test chemical can be classified as Acute toxicity Category 4 according to CLP regulation.

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from authoritative database.

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute oral toxicity of test chemical in Rat.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

770 mg/kg

No. of animals per sex per dose:

No data

Control animals:

not specified

Details on study design:

No data

Statistics:

No data

Preliminary study:

No data

Sex:

not specified

Dose descriptor:

LD50

Effect level:

770 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality observed

Mortality:

50% mortality observed at 770 mg/kg bw

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

No data

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral toxicity of test chemical in rat was observed to be 770mg/kg body weight.

Executive summary:

In acute oral toxicity study, rats were treated with test chemical at the concentration of 770mg/kg bw orally. 50% mortality observed in treated rat at 770mg/kg bw. Therefore, LD50 was considered to be 770mg/kg bw when rats were treated with test chemical orally.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

770 mg/kg bw

Quality of whole database:

Data is klimish 2 and from authoritative database

Additional information

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

1. In acute oral toxicity study, rats were treated with test chemical at the concentration of 770mg/kg bw orally. 50% mortality observed in treated rat at 770mg/kg bw. Therefore, LD50 was considered to be 770mg/kg bw when rats were treated with test chemical orally.

2. In acute oral toxicity study, mouse were treated with test chemical at the concentration of 1000 mg/kg bw orally. 50% mortality observed in treated mouse at 1000 mg/kg bw. Therefore, LD50 was considered to be 1000 mg/kg bw when mouse were treated with test chemical orally.

3. The study now reported was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats.

Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg resulted in distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 2 hours after the dosing and no mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg resulted in distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 1 hour after the dosing and no mortality after the dosing.

No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in salivation, distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 30 minutes to 6 hours after the dosing. One animal died at 24 hours after the dosing. As one mortality was observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in salivation, distension, diarrhoea, reduced locomotor activity, ataxic gait and test item coloured feces with onset at 30 minutes to 4 hours after the dosing. One animal died on day 3, one animal died on day 5 and one animal died on day 10 after the dosing.

All animals from 300 mg/kg dose group survived through the study period of 14 days and four animals died from 2000 mg/kg dose group after the dosing.

Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg dose group. 

Gross pathological examination revealed stomach, small and large intestine with test item coloured mucosa in animals sacrificed terminally from 2000 mg/kg dose group and stomach distended with test item coloured mucosa and small and large intestine distended with liquid test item coloured ingesta in found dead animals from 2000 mg/kg dose group.

The acute oral LD₅₀(Cut-off value) of test chemical was 500 mg/kg body weight.

Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category 4 (300 – ≤ 2000)” criteria of CLP.

4. In acute oral toxicity study, mouse was treated with test chemical at the concentration of 470 mg/kg bw orally. 50% mortality observed in treated rat at 470 mg/kg bw. Therefore, LD50 was considered to be 470 mg/kg bw when mouse was treated with test chemical orally.

5. In acute oral toxicity study, rabbits were treated with test chemical at the concentration of 180 mg/kg bw orally. 50% mortality observed in treated mouse at 180 mg/kg bw. Therefore, LD50 was considered to be 180 mg/kg bw when rabbits were treated with test chemical orally.

Thus from above summarised studies, it can be concluded that test chemical is acutely toxic and falls under category 4.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical is classified as Category 4 for acute oral toxicity