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EC number: 223-754-4
CAS number: 4051-63-2
No indication of systemic uptake after ingestion at the limit dose of 1000 mg/kg bw was observed in a GLP compliant study with rats following OECD testing guideline 422 (BASF 2013).
Pigment Red 177 was administered orally via gavage to groups of 10
male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg
body weight/day (mg/kg bw/d; test group 0), 100 mg/kg bw/d (test group
1), 300 mg/kg bw/d(test group 2) and 1000 mg/kg bw/d(test group 3).
Drinking water served as vehicle.
The objective of the study was to detect possible effects of the
test substance on the integrity and performance of male and female
reproductive systems including gonadal function, mating behavior,
conception, gestation and parturition. Furthermore, it was intended to
obtain information about the general toxicological profile including
target organs and the no observed adverse effect level (NOAEL) after
repeated oral administration. The duration of treatment covered a 2-week
pre-mating and mating period in both sexes, approximately 1 week
post-mating in males, and the entire gestation period as well as 4 days
of lactation followed by an additional treatment until one day before
After 2 weeks of premating treatment the F0 animals were mated to
produce F1 generation pups. Mating pairs were from the same test group.
Mating was discontinued as soon as sperm was detected in the vaginal
A detailed clinical observation (DCO) was performed in all animals
before initial test substance administration and, as a rule, thereafter
at weekly intervals.
Food consumption of the F0 parents was determined once weekly
during premating. For the dams food consumption was determined for
gestation days 0-7, 7-14, 14-20 and lactation days 1-4.
Body weights of F0 parents were determined once a week, in males
throughout the study and in females during premating and mating. During
gestation and lactation period, F0 females were weighed on gestation
days (GD) 0, 7, 14 and 20, after the day of parturition (postnatal day
[PND] 0) and on PND 4.
The pups were sexed and examined for macroscopically evident
changes on PND 0. They were weighed on PND 1 and on PND 4. Their
viability was recorded. At necropsy on PND 4, all pups were sacrificed
under isoflurane anesthesia with CO2 and examined macroscopically for
external and visceral findings.
Towards the end of the administration period a functional
observational battery was performed and motor activity was measured in 5
animals per sex and test group.
Clinicochemical and hematological examinations as well as
urinalyses were also performed towards the end of the administration
period in 5 animals per sex and test group.
The various analyses confirmed the
stability of the test substance in drinking water at room temperature
over a period of 7 days, the homogeneous distribution of the test
substance in drinking water and the
correctness of the prepared concentrations of the test-substance
preparations in drinking water. The red pigment caused the discoloration
of feces. No adverse effects were observed at any dose level. The NOEL
is 1000 mg/kg bw.
This finding is consistent with prediction of lack of systemic
uptake after ingestion based on the physico-chemical properties. This is
described in detail in the section of the toxicokinetic properties.
Therefore, testing of subchronic toxicity is not proposed.
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for
classification purposes under 67/548/EEC. No serious irreversible
effects were observed at dose levels of less than 150 mg/kg bw upon
subacute exposure. As a result the substance is not considered to be
classified for repeated dose toxicity under Directive 67/548/EEC, as
amended for the 31st time in Directive2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No.
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. There were no
significant toxic effects at doses of less than 300 mg/kg bw upon
subacute oral exposure in rats. As a result the substance is not
classified for repeated dose toxicity under Regulation (EC) No.
1272/2008, as amended for the third time in Directive EC 618/2012.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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