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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The results returned by these studies do not indicate that this substance is chronically toxic.  See 'Discussion' below.  

Weight of evidence shows that Black 400 is not toxic to daphnia.  

Key value for chemical safety assessment

Additional information

There are three Daphnia reproduction studies available, YKG 45a, YKG 45b both conducted in 1994 and YKG 31b conducted in 1991. The NOEC for the first of the Daphnia reproduction studies used a different statistical test to look at neonate numbers. They used the Williams’ test which is indicating effects on numbers, but it is very slight. The other two studies produce almost identical results, but here they used Dunnett’s test which, because it is less sensitive do not indicate an issue with neonate numbers and therefore the NOEC values on these two studies are greater than the top measured concentration (0.63 mg/L and 0.83 mg/L). The two later studies show no significant effects at the highest test level on survival growth or reproduction at 0.83 mg/l and 0.63 mg/L respectively these data were analysed using Dunnet’s test, a less sensitive statistical tool (all endpoints based on measured levels). From looking at the data there is a slight suggestion of effects however given the inert nature of the compound this is likely to be attributable to a physical effect due to the ingestion of particles (a similar size to algae) resulting in a dilution of food and therefore a slightly reduced growth and reproduction at the higher levels.

 

The studies were all conducted under OECD guideline 202 Whilst these guidelines have now been superseded the study was compliant with the guidelines as available at that time. OECD 202 guideline was in fact two guidelines in one document; Part 1 was the acute toxicity guideline and Part 2 was the chronic (reproduction) guideline which is used in these studies. Evaluation of the studies shows they were compliant with the guideline in place at that time and further evaluation, provided in section 13 of this dossier shows that they meet the latest requirements for registration under REACH.