Brightener 0503E

Endpoint summary

Description of key information

Subacute toxicity after repeated oral exposure (feeding) was evaluated on the basis of a 28-day (feeding) study according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) in rats (Wistar rats; male/female) with daily exposure of the test substance registered. Furthermore, in a two-generation study performed in rats with the analogue substance 2 (refer to IUCLID chapter 13) the low toxicity after prolonged treatment is demonstrated.  In this study the F0 parents were treated from 70 days before mating until euthanasia. ( for study summary refer to IUCLID chapter 7.8.1)
No repeated dermal toxicity test was performed with the test substance registered.  
No repeated inhalation toxicity test was performed with the test substance registered. 

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

Subacute toxicity after repeated oral exposure (feeding) was evaluated on the basis of a 28-day (feeding) study according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) in rats (Wistar rats; male/female) with daily exposure of the test substance registered. Five animals per sex and dose were tested. The dose ranges tested were 0, 50, 200 and 1000 mg/kg bw/day (nominal in diet). Concentration, homogeneity and stability of test item in the feed were determined. The 28 day treatment resulted in no test item related deaths, no clear test item related clinical signs during daily or weekly observations, no test item related findings during functional observation battery, no differences in mean daily food consumption or mean bodyweights upon mean absolute or relative organ weights, no macroscopical and no microscopical findings. The target dose levels were largely attained.

In a two-generation study performed with an analogue substance 2 (refer to IUCLID chapter 13) the F0 parents were treated from 70 days before mating until euthanasia at doses of 0, 100, 300 and 1000 mg/kg bw/day. The only test substance related effect noted was an increase in kidney weight without clear microscopic evidence effect at 300mg/kg bw/day ((P) females) and 1000 mg/kg bw/day (P and F1 males and females).

No repeated dermal toxicity test was performed with the test substance registered. The test material registered is of high molecular weight. It is used exclusively in aqueous solutions. Therefore, a significant skin penetration (bioavailability) and adverse effects via dermal exposure are not expected. An acute dermal toxicity test was performed as limit test resulting in an LD50 greater 2000 mg/kg bw. No systemic or local signs of toxicity were observed during the study.

No repeated inhalation toxicity test was performed with the test substance registered. The test material is produced and handled in industry exclusively in aqueous solutions. There are no spraying operations. Thus neither exposure nor risks are expected via the inhalation route.

The missing of any adverse findings in the 28-day repeated dose (feeding) study performed with the test substance registered up to the highest dose tested (i.e. 1000 mg/kg bw/day) and minimal findings in a two-generation study with an analogue substance 2 (refer to IUCLID chapter 13) in the mid and high dose, i.e. unspecific increase in kidney weight at 300mg/kg bw/day (P) females and 1000 mg/kg bw/day (P and F1 males and females)without clear microscopic evidence effect, provides indication that the toxic potential after prolonged treatment is low.

Justification for classification or non-classification

The missing of any adverse findings in the 28-day repeated dose (feeding) study performed with the test substance registered up to the highest dose tested (i.e. 1000 mg/kg bw/day) and minimal findings in a two-generation study with an analogue substance 2 (refer to IUCLID chapter 13) in the mid and high dose, provides indication that the toxic potential after prolonged treatment is low. Classification is not indicated.