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Administrative data

Description of key information

Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day (based on read-across)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
79.6 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Mode of Action Analysis / Human Relevance Framework

Additional information

The test substance 1,2 -Benzenedicarboxylic acid, di-C6 -10 alkyl esters was not investigated. A 90 -day sub-chronic oral toxicity has been undertaken on the structurally related substance 1,2 -Benzenedicarboxylic acid, di-C8 -10 -alkyl esters. The No Observed Adverse Effect level (NOAEL) for males is considered to be a concentration of 0.1 % in the diet, corresponding to a mean intake of 79.6 mg/kg bw/day based on hepatotoxic effects shown as histological changes in the liver and effects on liver enzymes. For females the NOAEL is considered to be 0.3 %, corresponding to a mean intake of 303.9 mg/kg bw/day on the basis of increased liver and kidney weights, effects on liver enzymes and haematological parameters.

Significant exposure to the skin is unlikely to occur since the substance is not widely used as such. Skin contact for workers is also unlikely to occur due to standard good hygiene working practice. Furthermore the results of laboratory animal studies show low acute oral and dermal toxicity. In the 28 - days repeated dose study via oral gavage administration only minor effects at higher doses have been observed. This intrinsic property/toxicity potential can be extrapolated to repeated dermal route administration.

The test substance has very low vapour pressure (< 0.001 mbar at 38°C), so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Furthermore the results of laboratory animal studies show low acute oral and dermal toxicity. In the 28 - days repeated dose study via oral gavage administration only minor effects at higher doses have been observed. This intrinsic property/toxicity potential can be extrapolated to repeated inhalation route administration.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification