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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.

Urethane

EC / List no.: 200-123-1 CAS no.: 51-79-6
Information source
# Harmonised classification for carcinogenicity: The substance is listed in Annex VI of CLP as: 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 (EXPERIMENTAL value); 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; Recommended for C category 1A or 1B by IMAP; carcinogen according to ISSCAN; reasonably anticipated to be a human carcinogen according to NTP 13th RoC # Suspected hazardous to the aquatic environment: DEMETRA Daphnia Magna toxicity model in VEGA (Q)SAR platform predicts that the chemical has a 48h EC50 of 4.26 mg/L (moderate reliability) # Suspected mutagen: CAESAR 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); Recommended for M category 1A or 1B by IMAP; The outcome in CTA assay is positive according to ISSCTA; In vivo micronucleus test outcome positive according to ISSMIC # Suspected persistent in the environment: Biodegradation NITE database in the Toolbox contains at least one experimental data from 28 days ready biodegradability test (OECD TG 301C or 301D) reporting a value lower than 60%;The Danish QSAR database contains information indicating that the substance is predicted as non readily biodegradable # Suspected skin sensitiser: The Toolbox profiler Protein binding alerts for skin sensitization by OASIS v1.3 gives an alert for skin sensitisation # Suspected toxic for reproduction: The Toolbox profiler DART scheme v.1.0 gives an alert for toxicity to reproduction;CAESAR developmental toxicity model in VEGA (Q)SAR platform predicts that the chemical is Toxicant (good reliability); Developmental/Reproductive Toxicity library (PG) in VEGA (Q)SAR platform predicts that the chemical is Toxicant (moderate reliability); DART database in the Toolbox reports that this substance as Known developmental potential

Download the full Annex III Inventory

You can download the full Annex III inventory as XLS format.

Download Annex III Inventory

 

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