Mixture of reaction products of substituted copper phthalocyanine, hydrogenated resin acids, alkaline earth metal chlorides, and copper phthalocyanine

Endpoint summary

Description of key information

One key study on acute oral toxicity according to OECD 423 is available. 
One key study on acute inhalation toxicity according to OECD 403 is available. 
One key study on acute dermal toxicity according to OECD 402 is available. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study has a reliability 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

4 000 mg/m³

Quality of whole database:

The study has a reliability 1.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study has a reliability 1.

Additional information

Acute oral:

B508 was administered by oral gavage to two subsequent groups of three females Wistar rats at 2000 mg/kg bw according to OECD 423 guideline and GLP Principles.

No mortality occurred. Hunched posture was noted in all animals and had resolved within 2 or 4 hours post-treatment. No effect on body weight gain was observed. No macroscopic abnormalities were found. The oral LD50 value of B508 was established to exceed 2000 mg/kg bw.

Acute inhalation:

B508 was administered by inhalation for 4 hours at a limit concentration to rats according to OECD 403 guideline and GLP Principles.

The actual concentration of 4.0 ± 0.8 mg/L was the maximum attainable concentration which could be generated in air for 4 hours.

One male was found dead approximately 2½ hours after initiation of exposure. Clinical signs included hunched posture, lethargy, laboured respiration, irregular breathing and rales. Body weight loss was shown by all survivors during the first week after exposure only. No abnormality was found at macroscopic post mortem examination of the animal that died during the study. Macroscopic post mortem examination of the surviving animals at termination revealed many bluish foci in the lungs of all animals and bluish discolouration of the skin of the tail.

The inhalatory 4 -hour LC50 of B508 in rats was found to exceed the maximum attainable concentration of 4.0 mg/L. Although one mortality was observed at this exposure level and clinical signs indicative of respiratory difficulties (laboured respiration and rales) were noted during a significant part of the observation period, it was considered that the 4-hour LC50 of B508 exceeds 5 mg/L.

Acute dermal:

B508 was administered to rats by a single dermal application at 2000 mg/kg bw for 24 hours according to OECD 402 guideline and GLP Principles.

No mortality occurred. No adverse clinical signs were observed. No effect on body weight gain after patch removal was noted. No macroscopic abnormalities were observed.The dermal LD50 of B508 in rats was established to exceed 2000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
One key study is available.

Justification for selection of acute toxicity – inhalation endpoint
One key study is available.

Justification for selection of acute toxicity – dermal endpoint
One key study is available.

Justification for classification or non-classification

Based on the results mentioned above, B508 does not have to be classified and has no obligatory labelling requirement for acute oral, dermal or inhalation toxicity in accordance with Regulation EC No. 1272/2008.