N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine

Endpoint summary

Description of key information

The material is harmful when applied to the skin and is practically non-toxic when administered orally or in vapor form.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-dates guidelines and GLPs, limited documentation, published in peer reviewed journal

Principles of method if other than guideline:

Single oral dose toxicity is estimated by gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, 4-5 weeks of age and weighing 90 to 120 grams. Doses were arranged in logarithmic series differing by a factor of two. Based upon mortalities during a 14-day observation period, the most probable LD50 and its 95% confidence limits are estimated by the method of Thompson and Weil.

GLP compliance:

no

Species:

rat

Sex:

male

Route of administration:

oral: gavage

Sex:

male

Dose descriptor:

LD50

Effect level:

3.25 mL/kg bw

Based on:

other: 85% aqueous solution

95% CL:

2.36 - 4.47

Remarks on result:

other: Based on a density of 0.912 mg/ml the LD50 would be 2964 mg/kg bw.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 in male rats of the 85% aqueous solution was 2964 mg/kg bw. The oral LD50 of the active ingredient would be 2519 mg/kg bw

Executive summary:

The oral LD50 in male rats of the 85% aqueous solution was 2964 mg/kg bw. The oral LD50 of the active ingredient would be 2519 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 519 mg/kg bw

Quality of whole database:

Studies were done before GLP and Guidelines were established.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: study report which meets basic scientific principles, acceptable with restrictions (limited documentation)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

no analytical verification of test substance concentration

Principles of method if other than guideline:

This test (also called inhalation hazard test) was performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (20 °C and 1002.6 hPa).
Several groups of 3 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder containing approximately 120 mL test substance for 8 hours. Compressed air without further filtering was used in order to generate the test substance atmosphere. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, which was given in the raw data, and the amount of air used during the exposure. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance.

GLP compliance:

no

Test type:

other: inhalation hazard test

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Mean body weight of animals before beginning of exposure:
- males: 177 g (test group 1); 186 g (test group 2);
- females: 173 g (test group 1); 170 g (test group 2).

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

Inhalation of an atmosphere enriched with vapour at 20°C. For enrichment, 200 L air/h was conducted through a Iayer of about 5 cm of the product.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

Mean concentration: 0.51 mg/L

No. of animals per sex per dose:

3 animals/sex/dose in one group (two groups are used)

Control animals:

yes

Sex:

male/female

Dose descriptor:

LC0

Effect level:

0.51 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: IHT: No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

Sacrificed animals: nothing abnormal detected.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Inhalation EC50 (8-hour) of the substance in rats was determined to be > 0.51 mg/l. No mortality or abnormal clinical signs were observed at this concentration.

Executive summary:

Inhalation EC50 (8-hour) of the substance in rats was determined to be > 0.51 mg/l. No mortality or abnormal clinical signs were observed at this concentration.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Work pre-dates guidelines and GLPs, Limited documentation, published in peer-reviewed journal

Principles of method if other than guideline:

Method: other: no data

GLP compliance:

no

Species:

rabbit

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2.02 mL/kg bw

95% CL:

1.24 - 3.29

Remarks on result:

other: Based on a density of 0.912 mg/ml the LD50 would be 1842 mg/kg bw

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 in rabbits of the 85% aqueous solution is 1842 mg/kg/b.w. The dermal LD50 of the test material is 1566 mg/kg bw.

Executive summary:

The dermal LD50 in rabbits of the 85% aqueous solution is 1842 mg/kg/b.w. The dermal LD50 of the test material is 1566 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 566 mg/kg bw

Additional information

Oral LD50 values in rats and mice exceeded 2000 mg/kg bw.

No mortality was observed when rats were exposed for 8 hours to atmospheres that had been saturated with the volatile parts of the compound. No clinical signs or observations after gross pathology were observed. The LC0 was 0.51 mg/L air (nominal).

The acute dermal LD50 in rabbits is 1566 mg/kg bw

Justification for selection of acute toxicity – oral endpoint
Four studies are available one for mice and three for rats. All LD50 values exceed 2000 mg/kg. The rat study with the lowest LD50 value was selected, which represents the most conservative approach.

Justification for selection of acute toxicity – inhalation endpoint
Best documentation of the two available studies

Justification for selection of acute toxicity – dermal endpoint
Only study available

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 classification is only required for dermal toxicity (cat 4). Data from other routes of exposure do not demonstrate a hazard requiring classification.