Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

RA: OECD 422; GLP; Sprague-Dawley rat oral 46/41-45 d (m/f); 250, 500, 1000 mg/kg bw/day; no adverse effects; NOAEL (reproduction and fertility) >1000 mg/kg bw/day (2002)

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See read-across justification
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
other: read-across substance
Sex:
male/female
Basis for effect level:
other: no effects presumed
Critical effects observed:
no
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 1 000 mg/kg bw/day
Based on:
other: read-across substance
Sex:
male/female
Basis for effect level:
other: no effects presumed
Critical effects observed:
no
Reproductive effects observed:
no
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There were no experimental data from the target substance itself. However, an assessment can be made based on experimental data from an analogoue substance.

Results in a Combined repeated dose toxicity and reproduction/developmental toxixity study conducted with the analogue substance Pigment Yellow 53 (CAS 8007 -18 -9) confirmed no adverse effects on fertility and reproduction in parental animals. Therefore, no additional studies for reproduction and developmental toxicity for the target substance are considered necessary.

Pigment Yellow 53 (CAS 8007-18-9) was administered to groups of Sprague Dawley rats (12/sex) at concentrations of 0 (vehicle), 250, 500, 1000 mg/kg bw/d. Males were treated for 46 days and females from 14 days before mating to day 4 of lactation. No effects on male and female reproduction were observed in any of the dosing groups. Therefore, the NOAEL for reproduction was considered to be 1000 mg/kg/day or more (unpublished data, 2002, OECD 422, GLP).

Effects on developmental toxicity

Description of key information

RA: OECD 414; GLP; Wistar rats; 100, 300, 1000 mg/kg bw/day; no adverse effects; NOAEL (developmental toxicity) >1000 mg/kg bw/day (2017).

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:
See read-across justification
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Guideline:
other: OECD 422
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
other: read-across substance
Basis for effect level:
other: no effects presumed
Abnormalities:
no effects observed
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day
Based on:
other: read-across substance
Sex:
male/female
Basis for effect level:
other: no effects presumed
Abnormalities:
no effects observed
Developmental effects observed:
no
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
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

There were no experimental data from the target substance itself. However, an assessment can be made based on experimental data from analogous substances. Results in both developmental toxicity studies performed with the analogue substances confirmed no adverse effects on maternal and prenatal development. Therefore, no additional studies for reproduction and developmental toxicity for the target substance are considered necessary.

In a prenatal developmental toxicity study Pigment 53(CAS 8007-18-9) was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) at concentrations of 100, 300, and 1000 mg/kg bw/day. A yellow discolored content of the stomach was the only treatment-related effect recorded in 5 out of 25 mid-dose females (20%) and in 6 high-dose females (24%). However, it is not considered as an adverse, toxic effect by itself. In conclusion, the NOAEL for maternal and prenatal developmental toxicology is greater than 1000 mg/kg bw/d (unpublished report, 2017a, OECD 414, GLP).

Pigment Brown 24(CAS 68186-90-3) was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) at concentrations of 100, 300, 1000 mg/kg bw/day. Yellowish discolored feces were the only treatment-related effect recorded for all females of the high-dose group (1000 mg/kg bw/d) from GD 14 onwards until terminal sacrifice (GD 20). This discoloration mirrors the presence of the test substance (or its metabolites) in the gastrointestinal tract; however, it is not considered as an adverse toxic effect. Thus, the NOAEL for maternal and prenatal developmental toxicology is greater than 1000 mg/kg bw/d (unpublished report, 2017b, OECD 414, GLP).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

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, as amended for the thirteenth time in Regulation (EC) 2018/1480 of 4 October 2018.

Additional information