2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}

Endpoint summary

Description of key information

LD50, oral rat: >2000 mg/kg bw
LC50, inhal rat: > 0.649 mg/L (active ingredient)
LD50, dermal rat: >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity:

In the key oral toxicity study (RCC 651407, 1997, OECD 401) 5 male and 5 male and female fasted Wistar rats were exposed each by gavage to Bemotrizinol (2000 mg/kg bw). Animals were observed for 14 days. There was no mortality. No clinical signs, no mortality and no evident adverse effects on body weights were observed. At necropsy, no apparent macroscopic abnormalities were observed. The oral LD50 was determined to be > 2000 mg/kg bw.

 

Acute inhalation toxicity:

An OECD-guideline and GLP compliant inhalation (nose only) toxicity study (RCC B28225, 2008) on a formulation containing Bemotrizinol, diluted in phenethyl benzoate (final concentration 10%) indicated an LC50 of > 0.649 mg/L when administered to rats for a single 4 -hour period. These findings confirm the absence of any acute inhalative toxicity of Bemotrizinol. Since Bemotrizinol has not been tested up to the limit concentration, no final conclusion on classification can be drawn, although in light of the present data from oral and dermal toxicity studies, acute toxicity via the inalative route is unlikely. Furthermore, inhalative exposure is not considered to be the major route of exposure. Therefore an acute toxicity study via the inhalative route is scientifically not required in accordance with column 2 of REACH Annex VIII, and is not in line with animal welfare requirements.

 

Acute dermal toxicity:

In an acute dermal toxicity study (RCC 651420, 1997, OECD 402, acc. to GLP), Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw Bemotrizinol to the clipped skin and covered by semi-occlusive dressing for 24 hours. The animals were observed for 14 days. No mortality occurred and no signs of systemic toxicity or skin effects were seen. No macroscopic pathologic abnormalities were noted. Accordingly, the LD 50 was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity

Based on the results of acute oral toxicity testing (LD50 > 2000 mg/kg), Bemotrizinol does not cause any adverse effects after acute oral uptake and is not to be classified under the EU CLP classification criteria (EU Regulation 1272/2008).

Acute inhalation toxicity

The results obtained from inhalation study with rats of 10% bemotrizinol in phenethyl benzoate indicate the LC50 > 0.6492 mg/L.

Considering the rules of CLP, a conclusion of the classification of bemotrizinol above category 3 cannot be drawn based on this study. However, combining this result with the lack of toxicity in the acute oral and dermal studies, it can be concluded, that a hazardous potential of bemotrizinol after acute inhalation is unlikely.

Acute dermal toxicity

Based on the results of the study (rat dermal LD50 >2000 mg/kg), Bemotrizinol is not to be classified under the EU CLP classification criteria (EU Regulation 1272/2008).