2-(4,6-bis-(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(octyloxy)-phenol

Endpoint summary

Description of key information

Acute oral toxicity:

Acute oral toxicity study was performed according to OECD Guideline 401 (Acute Oral Toxicity) to determine the toxic nature of test chemical on rats. An LD50 of >5000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’.

Acute Dermal toxicity:

Acute dermal toxicity study was performed to determine the toxic nature of test chemical on rabbits. An LD50 of >10000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’.

Acute Inhalation toxicity:

An acute inhalation toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure.The estimated vapour pressure of test chemical at 25 deg C was observed to be 2.08E-17 mmHg (2.78E-15 Pa). Hence, this endpoint was considered for waiver.

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

not specified

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 rats/each sex
5 Females
5 male

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Preliminary study:

not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths:0

Clinical signs:

other: Signs of toxicity ralated to does levels: No significant clinical signs were produced at any time

Gross pathology:

Effects on organs:
No gross lesions or abnormalities were noted during necropsy

Interpretation of results:

other: Not classified

Conclusions:

Acute oral toxicity study was performed according to OECD Guideline 401 (Acute Oral Toxicity) to determine the toxic nature of test chemical on rats. An LD50 of >5000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’.

Executive summary:

Acute oral toxicity study was performed according to OECD Guideline 401 (Acute Oral Toxicity) to determine the toxic nature of test chemical on rats. 5 male and 5 female Sprague-Dawley rats were administered test chemical at a dose range of 5000 mg/kg bw via oral gavage route. Vehicle used was corn oil. No mortality was observed after the test, no significant clinical signs were produced at any time and no gross lesions or abnormalities were noted during necropsy. An LD50 of >5000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

K1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

K2

Additional information

Acute Oral toxicity:

Acute oral toxicity study was performed according to OECD Guideline 401 (Acute Oral Toxicity) to determine the toxic nature of test chemical on rats. 5 male and 5 female Sprague-Dawley rats were administered test chemical at a dose range of 5000 mg/kg bw via oral gavage route. Vehicle used was corn oil. No mortality was observed after the test, no significant clinical signs were produced at any time and no gross lesions or abnormalities were noted during necropsy. An LD50 of >5000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’.

Acute Dermal Toxicity:

2)Male albino rabbits were used for dermal toxicity test.An aqueous paste of the product was held in continuous 24-hr contact with the closely-clipped skin of the belly by an impervious cuff, according to the technique described by Draize, Woodward & Calvery (I 944). At the end of the period of exposure, the cuff and any excess of the dose were removed and the skin was examined for signs of irritation. All animals in these single-dose tests were observed for 7 days after the dose was given or applied.The single dermal LD50 of test chemical is considered to be greater than 10 g/kg, since a group of five rabbits survived an application of that dosage. Neither signs of systemic intoxication nor indications of skin irritation were noted, and no relevant gross pathology was found when the animals were killed and autopsied. Thus based on the LD50 value of >10,000 mg/kg bw, the test chemical was 'Not classified'.

3) Acute dermal toxicity test was performed on rats to deteremine the toxic nature of test chemical. An LD50 of >2000 mg/kg bw was observed indicating that the test chemical is not toxic in nature and falls under category 'Not Classified'.

Acute Inhalation Toxicity:

An acute inhalation toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure.The estimated vapour pressure of test chemical at 25 deg C was observed to be 2.08E-17 mmHg (2.78E-15 Pa). Hence, this endpoint was considered for waiver.

Justification for classification or non-classification

Based on the available data, And LD50 og >5000 mg/kg bw was observed for Acute oral toxicity and an LD50 of >10000 mg/kg bw was observed for Acute dermal toxicity. Acute inhalation study was considered waiver for exposure assessment. Thus, the test chemical is 'Not classified' for Acute oral, dermal and inhalation toxicity.