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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

There were no effects on fertility, the ‘No Observed Effect Level’ (NOEL) for fertility is considered to be 175 mg/kg bw/day for the structural analogue substance.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
175 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
High quality GLP study
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The oral administration of the structural analogue substance to rats by gavage, at dose levels of 25, 75 and 175 mg/kg bw/day in this study conducted according to OECD Guideline 422, resulted in treatment-related microscopic effects in animals of either sex treated with 175 mg/kg bw/day and in males treated with 75 mg/kg bw/day. The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 75 mg/kg bw/day for females and 25 mg/kg bw/day for males.

The reduced body weight development and microscopic changes evident in the stomach were considered to be the result of an irritant effect of the test item rather than a true systemic effect and as such was considered adaptive and non-adverse. Therefore, a ‘No Observed Adverse Effect Level’ (NOAEL) can be established at 175 mg/kg bw/day for animals of either sex.

There were no effects on fertility, the ‘No Observed Effect Level’ (NOEL) for fertility is considered to be 175 mg/kg bw/day.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
175 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
high quality GLP study
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

In the above (effects on fertility) discussed repeated dose toxicity study with reproductive/developmental toxicity screening test, a 'No Observed Adverse Effect Level' (NOAEL) for developmental toxicity may be established at 175 mg/kg bw/day due to the effects seen in litter size, litter weights and offspring body weight gain being minimal, group mean values being within historical control ranges and most likely a result of the impaired health of the dam from lower body weight gain and food consumption during lactation.

Justification for classification or non-classification

Based on the results of the repeated dose toxicity study with reproductive/developmental screening test, Basic Red 046 is considered to be not a reproductive/developmental toxicant and hence does not warrant classification as per the criteria of Regulation (EC) No. 1272/2008.

Additional information