Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A developmental/teratogenicity study without adverse effects is available for a structural analogue, and is offered in section 7.8.2. Hence, a reproductive/developmental screening study has not to be performed according to Column 2 of REACH Annex VIII. Furthermore, no effects were seen on reproductive organs in the repeat dose study, and the category of substance (reactive dyes) is not known for reproductive toxicity effects. On the basis of animal welfare it is proposed that the developmental/teratogenicity study in conjunction with the lack of effects noted in the other toxicity studies is suitable to address this endpoint.


Short description of key information:
The absence of adverse effects on gonads in the repeat dose study together with the absence of adverse effects in a pre-natal development toxicity study and the overall absence of reproductive toxicity effects of the category of substance (reactive dyes) suggests that the test substance does not have reproductive toxicity potential.

Effects on developmental toxicity

Description of key information
No embryotoxic or teratogenic effects were observed with the structural analogue in the pre-natal development toxicity study.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
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

In a limit test, the test substance, Reactive Black 5, was administered orally on Days 7 to 16 of pregnancy. A simultaneous control group of the same size received the vehicle without test substance. On Day 21 of pregnancy, the dams were killed and delivered by caesarean section. The foetuses were then examined morphologically for developmental disorders. The study showed that the repeated oral administration of the test substance at a dose of 1,000 mg/kg bw in the sensitive phase of organogenesis did not lead to any impairment of the general physical condition of the dams or impaired intrauterine development of the foetuses. The morphological examination of the foetuses with regard to stage of development, outwardly detectable anomalies as well as anomalies of the internal organs and the skeleton showed no indication of an embryotoxic or teratogenic effect of the test substance. The findings observed are to be regarded as spontaneous in origin. On the basis of the results of this limit test, the NOAEL for the test substance in rats following oral administration lies at 1,000 mg/kg bw with regard to maternal and embryofoetal toxicity and teratogenicity. No teratogenic effect was observed.

Justification for classification or non-classification

No adverse effects on reproduction toxicity observed - no classification necessary

Additional information