Annex III inventory
Annex III inventory
Annex III inventory
ECHA compiled an inventory of substances likely to meet the criteria of Annex III to the REACH Regulation. The aim is to support registrants in identifying whether reduced minimum information requirements or a full Annex VII information set is required.
The inventory was produced using publicly available databases with experimental data and by using (Q)SAR model results. Indications for hazardous toxicological or ecotoxicological properties together with information on uses and other available relevant information have to be compared with the criteria in Annex III.
The fact that a substance is not in this list does not necessarily mean that the criteria for Annex III are not met. Likewise, if a substance is on this inventory, a registrant can still benefit from the reduced information requirements if it is justified.
Note that the inventory is not a tool for classification, it only shows indications for concern. For instance, the fact that a substance is indicated as "Suspected mutagen" does not mean that ECHA considers it as a classified mutagen. All evidence should be taken into account before concluding on the need for classification.
3,3'-dimethoxybenzidine
EC / List no.: 204-355-4 CAS no.: 119-90-4| Information source | # Suspected acutely toxic via the oral route: The Danish QSAR database contains information indicating that the substance is predicted as toxic via the oral route. # Harmonised classification for acute toxicity: The substance has the following harmonised classification in Annex VI of CLP: Acute Tox. 4 # Harmonised classification for carcinogenicity: The substance has the following harmonised classification in Annex VI of CLP: Carc. 1B # Suspected carcinogen: The Toolbox profiler 'Carcinogenicity (genotox and nongenotox) alerts by ISS' gives an alert for carcinogenicity; CAESAR Carcinogenicity model in VEGA (Q)SAR platform predicts that the chemical is Carcinogen (moderate reliability); ISS Carcinogenicity model in VEGA (Q)SAR platform predicts that the chemical is Carcinogen (EXPERIMENTAL value); IARC monographs classified the substance as carcinogenic or probably/possibly carcinogenic; carcinogen according to ISSCAN; reasonably anticipated to be a human carcinogen according to NTP 13th RoC # Suspected hazardous to the aquatic environment: Fathead Minnow toxicity model (EPA) in VEGA (Q)SAR platform predicts that the chemical has a 96h LC50 of 34.91 mg/L (moderate reliability); Fish toxicity classification (SarPy/IRFMN) model in VEGA (Q)SAR platform predicts that the chemical is 'Toxic-2 (between 1 and 10 mg/l) (good reliability)'; Fish Acute Toxicity model (KNN/Read-Across) in VEGA (Q)SAR platform predicts that the chemical has a 96h LC50 of 3.63 mg/L (moderate reliability);The Danish QSAR database contains information indicating that the substance has a 96h LC50 to fish of 30.41 mg/L; The Danish QSAR database contains information indicating that the substance has a 48h EC50 to Daphnia of 1.74 mg/L; The Danish QSAR database contains information indicating that the substance has a 96h EC50 to green algae of 2.65 mg/L # Suspected mutagen: The Toolbox profiler 'DNA alerts for AMES, MN and CA by OASIS v.1.3' gives an alert for mutagenicity; The Toolbox profiler 'in vitro mutagenicity (Ames test) alerts by ISS' gives an alert for mutagenicity; The Toolbox profiler 'Protein binding alerts for Chromosomal aberration by OASIS v1.1' gives an alert for mutagenicity; CAESAR Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); ISS Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); KNN Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); SARPY Mutagenicity model in VEGA (Q)SAR platform predicts that the chemical is Mutagen (EXPERIMENTAL value); mutagen according to ISSSTY # Suspected persistent in the environment: Ready biodegradability model (IRFMN) in VEGA (Q)SAR platform predicts that the chemical is NON Readily Biodegradable (EXPERIMENTAL value);The Danish QSAR database contains information indicating that the substance is predicted as non readily biodegradable # Suspected toxic for reproduction: CAESAR developmental toxicity model in VEGA (Q)SAR platform predicts that the chemical is Toxicant (good reliability) |
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