Reaction products of amines, dicoco alkyl and glycollic acid

Endpoint summary

Description of key information

Oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of 1000 mg/kg/day did not result in any toxicologically significant changes. The ‘No Observed Effect Level’ (NOEL) was considered to be 1000 mg/kg/day. 
Further 90-day repeat dose studies in the rat are scientifically unjustified as the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day limit test.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

There is one key 28-day repeat oral dose study.

In a study performed according to OECD 407, EU Method B7 and Japanese Guidelines, the test material was administered by gavage to three groups, each of five male and five female Sprague-Dawley Crl:CD@ (SD) IGS BR strain rats, for up to twenty-eight consecutive days, at dose levels of 25, 250 and 1000 mg/kg/day. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). Two recovery groups, each of five males and five females, were treated with the high dose (1000 mg/kg/day) or the vehicle alone for up to twenty-eight consecutive days and then maintained without treatment for a further fourteen days.

Clinical signs, bodyweight development and food and water consumption were monitored during the study. Haematology, blood chemistry and urinalysis were evaluated for all non-recovery group animals at the end of the treatment period and for all surviving recovery group animals at the end of the treatment-free period.

All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from non-recovery high dose and control animals was performed.

Mortality. One control male was killed on humane grounds due to the severity of its clinical observations on Day 26. There were no other unscheduled deaths during the study.

Clinical Observations. No clinically observable signs of toxicity were detected throughout the study period.

Behavioural Assessment.Weekly behavioural assessments revealed no treatment-related changes in the parameters measured.

Functional Performance Tests. There were no treatment-related changes in the functional performance parameters measured.

Sensory Reactivity Assessments. There were no treatment-related changes in sensory reactivity.

Bodyweight.No adverse effect on bodyweight or bodyweight gains were detected.

Food Consumption. No adverse effect on dietary intake or food efficiency was detected.

Water Consumption. Daily visual inspection of water bottles revealed no intergroup differences.

Haematology.There were no toxicologically significant changes in the haematological parameters investigated.

Blood Chemistry.There were no toxicologically significant effects on the blood chemistry parameters investigated.

Urinalysis. No treatment-related urinalytical effects were detected.

Organ Weights. No toxicologically significant treatment-related organ weight changes were detected.

Necropsy. No treatment-related macroscopic abnormalities were detected.

Histopathology. No treatment-related changes were detected.

Conclusion.

Oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of 1000 mg/kg/day did not result in any toxicologically significant changes. The ‘No Observed Effect Level’ (NOEL) was considered to be 1000 mg/kg/day.

 

Justification for classification or non-classification

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for subacute repeat oral dose toxicity in the absence of systemic toxicity at the maximum dose concentration.