Reaction products of tetraethylenepentamine and maleic anhydride

Endpoint summary

Description of key information

Acute toxicity: oral: A K1, GLP-compliant acute oral toxicity test was performed in female Wistar rats according to the OECD guideline 420 and EU Method B.1 bis (Sanders, 2014a). The LD50 for the oral route was determined to be greater than 2000 mg/kg bw (equivalent to 1000 mg/kg bw of active ingredient). The commercial product, containing a 50% solution, doesn’t need to be classified on the basis of the available data.
    
 
Acute toxicity: inhalation: An acute inhalation study does not need to be conducted as acute oral and acute dermal toxicity studies are available, according to Column 2 adaptations in the REACH regulation.

Acute toxicity: dermal: A K1, GLP-compliant acute dermal toxicity test was performed in male and female Wistar rats according to OECD guideline 402 and EU Method B.3 (Sanders, 2015). The LD50 for the dermal route was determined to be greater than 4000 mg/kg bw (equivalent to 2000 mg/kg bw of active ingredient). No classification is needed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute toxicity: oral:

Sanders (2014a) investigated the acute oral toxicity of the 50% solution of the substance via gavage of 300 and 2000 mg/kg bw in 6 female Wistar rats (1 animal in the 300 mg/kg dose group and 5 animals in the 2000 mg/kg dose group) (K1, GLP). There were no deaths observed. No signs of systemic toxicity were noted during the observation period. All animals showed expected gains in body weight over the observation period and no abnormalities were noted at necropsy. The acute oral LD50 was determined to be greater than 2000 mg/kg bw (equivalent to 1000 mg/kg bw of active ingredient).

Acute toxicity: inhalation:

No reliable studies were available for the inhalation route. An acute inhalation study does not need to be conducted as acute oral and acute dermal toxicity studies are available, according to Column 2 adaptations in the REACH regulation.

Acute toxicity: dermal:

Sanders (2015) investigated the acute dermal toxicity of the substance in 5 male and 5 female Wistar rats after 24 hours of exposure to 4000 mg/kg bw of the test substance (equivalent to 2000 mg active ingredient/kg bw) (K1, GLP). There were no deaths observed. No signs of systemic toxicity were noted during the observation period. There were no signs of dermal irritation. Animals showed expected gains in body weight, except for two females which showed body weight loss during the first week but expected body weight gain during the second week. No abnormalities were observed at necropsy. After 14 days of observation, the dermal LD50 was determined to be greater than 4000 mg test substance/kg bw (equivalent to 2000 mg/kg bw of active ingredient).

Justification for selection of acute toxicity – oral endpoint : Only one reliable study available.

Justification for selection of acute toxicity – inhalation endpoint : No reliable studies were available for the inhalation route. An acute inhalation study does not need to be conducted as acute oral and acute dermal toxicity studies are available, according to Column 2 adaptations in the REACH regulation.

Justification for selection of acute toxicity – dermal endpoint : Only one reliable study available.

Justification for classification or non-classification

Based on the results of the acute oral and acute dermal toxicity study and according to the criteria of the CLP Regulation, the commercial product, containing a 50% solution, doesn't need to be classified on the basis of the available data.