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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Pre-natal developmental toxicity studies were conducted via gavage in rats with the pigments chromium iron oxide and zirconium praseodymium yellow zircon in rats. The studies were performed according to OECD test guideline 414 and in compliance with GLP.


No maternal toxicity up to the highest dose level of 1000 mg/kg bw/day. Furthermore, there was no embryo-toxicity and no effect on the developing foetuses. No malformations or variations were noted during (i) the macroscopic inspection at laparotomy (including an external inspection and gross inspection of the organs), (ii) the skeletal examination according to Dawson and (iii) the soft tissue examination according to Wilson. No incidences of skeletal retardations were observed.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Based on the explanation given in the read-across assessment framework document (attached in IUCLID section 13.2) an analogue approach for read-across of the endpoint “developmental toxicity" from the structural analogues to the target substance is considered justified.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species:
rat
Clinical signs:
no effects observed
Dermal irritation (if dermal study):
not examined
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Endocrine findings:
no effects observed
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not examined
Other effects:
not examined
Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
no effects observed
Dead fetuses:
no effects observed
Changes in pregnancy duration:
not examined
Changes in number of pregnant:
no effects observed
Other effects:
no effects observed
Key result
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
no effects where observed with neither of the two source substances (zirconum praeodymium yellow zircon and chromium iron oxide)
Abnormalities:
no effects observed
Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
not examined
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
not examined
Anogenital distance of all rodent fetuses:
no effects observed
Changes in postnatal survival:
not examined
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed
Other effects:
no effects observed
Key result
Remarks on result:
not determinable due to absence of adverse toxic effects
Remarks:
no effects where observed with neither of the two source substances (managnese alumina pink corundum and chromium iron oxide)
Abnormalities:
no effects observed
Developmental effects observed:
no
Conclusions:
Pre-natal developmental toxicity studies were conducted via gavage in rats to assess the effect of the pigments chromium iron oxide and zirconium praseodymium yellow zircon on rats. The studies were performed according to OECD test guideline 414 and in compliance with GLP.
Both pigments in 0.8% aqueous hydroxypropylmethyl-cellulose gel each were administered via gavage to groups of pregnant female Crl:CD (SD) rats (n = 20) at dose levels of 100, 300, and 1000 mg/kg bw/day. The administration occurred once daily from gestation day 6 to gestation day 20. A vehicle control group was run concurrently.
During the observation of the dams, no test item-related effects were observed for mortality, clinical signs, body weight, body weight gain, gravid uterus weight, carcass weight, food consumption, water consumption, gross pathology, thyroid weights, thyroid hormone concentrations (triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH)), and histopathology of the thyroid. Furthermore, no test item-related effect was noted on the reproductive parameters (number of corpora lutea, implanation sites, resorptions (total, early and late) and foetuses (dead and alive) as well as the index of pre- and post implantation loss).
No foetal deaths occurred and no test item-related effects were observed on body weight, placental weight and foetal developmental parameters (anogenital distance or testicular developmental of the male foetuses). Also, no test item-related malformations or variations were noted during (i) the macroscopic inspection at laparotomy (including external inspection and a gross inspection of the organs), (ii) the skeletal examination according to Dawson and (iii) the soft tissue examination according to Wilson. Lastly, no test item-related retardations (delay in ossification) were noted in any of the treatment groups.

Based on the results, the NOAEL for maternal toxicity and developmental toxicity is considered to be greater than 1000 mg/kg bw/day for both pigments.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Substance-specific information on developmental toxicity of zirconium zircon with encapsulated hematite is not available. Read-across data from the two source substances chromium iron oxide and zirconium praseodymium yellow zircon were used in an analogue approach in order to conclude on the hazard profile of zirconium zircon with encapsulated hematite. For further details please refer to the read -acrosss assessment framework document in IUCLID section 13.2.


Pre-natal developmental toxicity studies were conducted via gavage in rats to assess the effect of the pigments chromium iron oxide and zirconium praseodymium yellow zircon on rats. The studies were performed according to OECD test guideline 414 and in compliance with GLP. 


Both pigments in 0.8% aqueous hydroxypropylmethyl-cellulose gel each were administered via gavage to groups of pregnant female Crl:CD (SD) rats (n = 20) at dose levels of 100, 300, and 1000 mg/kg bw/day. The administration occurred once daily from gestation day 6 to gestation day 20. A vehicle control group was run concurrently.


During the observation of the dams , no test item-related effects were observed for mortality, clinical signs, body weight, body weight gain, gravid uterus weight, carcass weight, food consumption, water consumption, gross pathology, thyroid weights, thyroid hormone concentrations (triiodothyronine (T3), thyroxine (T4), and thyroid stimulating hormone (TSH)), and histopathology of the thyroid. Furthermore, no test item-related effect was noted on the reproductive parameters (number of corpora lutea, implanation sites, resorptions (total, early and late) and foetuses (dead and alive) as well as the index of pre- and post implantation loss).


No foetal deaths occurred and no test item-related effects were observed on body weight, placental weight and foetal developmental parameters (anogenital distance or testicular developmental of the male foetuses). Also, no test item-related malformations or variations were noted during (i) the macroscopic inspection at laparotomy (including external inspection and a gross inspection of the organs), (ii) the skeletal examination according to Dawson and (iii) the soft tissue examination according to Wilson. Lastly, no test item-related retardations (delay in ossification) were noted in any of the treatment groups.


Based on the results, the NOAEL for maternal toxicity and developmental toxicity is considered to be greater than 1000 mg/kg bw/day for both pigments.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008.

Additional information