C.I. Pigment Blue 29 was studied in female rats in a single dose oral toxicity test at 2000 mg/kg in first and second trials. On observation for general signs, only bluish feces, derived from the color of the test article, were noted. The chemical was thus classified into category 5 of the GHS regarding acute toxicity.

C.I. Pigment Blue 29 was studied for oral toxicity in rats in an OECD combined repeated dose toxicity study with the reproductive/developmental toxicity screening test at doses of 0, 100, 300 and 1000 mg/kg/day.

With regard to repeated dose toxicity, histopathological examination in the 1000 mg/kg group revealed slight squamous hyperplasia at the limiting ridge of the forestomach in both sexes. This change demonstrated reversibility or a tendency for reversibility in the male recovery group and the female satellite group. The NOAEL(s) for repeated dose toxicity is considered to be 300 mg/kg/day for parental animals of both sexes.

With regard to reproductive and developmental toxicity, the parental animals exhibited no alterations in reproductive parameters. There were also no significant differences in offspring parameters. The NOAEL(s) for reproductive/developmental toxicity is thus considered to be 1000 mg/kg/day for reproductive performance of parental animals and for offspring development.

1. Single Dose Oral Toxicity 1)

Composition	:	SiO2 39.60 %, Al2O3 23.76 %, Fe2O3 0.45 %, S 12.08 %, Na2O 22.59 %, unknown 1.52 %
Test species/strain	:	Rat/Crj:CD(SD)IGS
Test method	:	OECD Test Guideline 423
Route	:	Oral(gavage)
Dosage	:	2000 mg/kg
Number of animals/group	:	Females, 6
Vehicle	:	1 % Sodium carboxymethylcellulose solution
GLP	:	Yes

　Test results:

On observation for general signs, only bluish feces, derived from the color of the test article, were noted at 2000 mg/kg. The chemical was thus classified into category 5 of the GHS regarding acute toxicity.

2. Repeated Dose and Reproductive/Developmental Toxicity 2)

Composition	:	SiO2 39.60 %, Al2O3 23.76 %, Fe2O3 0.45 %, S 12.08 %, Na2O 22.59 %, unknown 1.52 %
Animal species/strain	:	Rat/Crl:CD(SD)
Study method	:	OECD Test Guideline 422
Route	:	Oral(gavage)
Dosage	:	0(vehicle), 100, 300, 1000 mg/kg/day(satellite group for recovery of 5 females; 0, 1000 mg/kg/day)
Number of animals/group	:	Males, 12; females, 12
Vehicle	:	1.0 % Methylcellulose
Administration period	:	42 Days for males 14 Days before mating to day 4 of lactation for females 42 Days for the satellite group for recovery of females
Terminal killing	:	Day 43 for males Day 57 for the recovery group of males Day 5 of lactation for females Day 57 for the satellite group for recovery of females
GLP	:	Yes

　Test results :

<Repeated dose toxicity>

In the 1000 mg/kg group: Histopathological examination revealed slight squamous hyperplasia at the limiting ridge of the forestomach in both sexes. This change demonstrated reversibility or a tendency for reversibility in the male recovery group and the female satellite group.

The NOAEL(s) for repeated dose toxicity is considered to be 300 mg/kg/day for parental animals of both sexes.

<Reproductive and developmental toxicity>

The parental animals exhibited no alterations in reproductive parameters. There were also no significant differences in offspring parameters.

The NOAEL(s) for reproductive/developmental toxicity is considered to be 1000 mg/kg/day for reproductive performance of parental animals and for offspring development.