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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The key ecotoxicity values of the registered substance are as follow:

-         Aquatic Invertebrates: 48-h EL50 > 100 mg test material/L (experimental study on the registered substance)

-         Aquatic algae: 72-h ErL50 > 1000 mg test material/L (read-across from an experimental GLP study on Labdanum gum)

Based on these results, the acute EL50 are higher than 1 mg/L.

Therefore, the registered substance would not be classified as acute 1 to aquatic organisms in accordance with the classification of the CLP.

Additional information

The registered substance is a Natural Complex Substance (UVCB).

A study performed on the registered substance in order to assess its toxicity to aquatic invertebrates (Daphnia magna) was available.

This study was performed in compliance with OECD 202 guideline.

However, a toxicity study on freshwater algae for the registered substance was not available. Therefore, in order to assess the toxicity of the registered substance on freshwater algae, the results from an experimental study performed on Labdanum gum have been used. In this study, the toxic effect of the test item LABDANUM GUM to the growth of the unicellular algal species Pseudokirchneriella subcapitata was investigated in a static limit test, according to the OECD 201 guideline. The read-across justification can be found in the related iuclid study record.

For these both annex VII endpoints, the studies used were performed under GLP conditions using Water Accommodated Fractions, in compliance with the “Guidance document on aquatic toxicity testing of difficult substances and mixtures” (OECD No. 23). In addition, these studies have been reviewed and were considered reliable. Indeed, they respected the requirements of both guidelines and the respective validity criteria were fulfilled.

Therefore, it has been decided to use for annex VII endpoints the results from these two studies as key ecotoxicity values for the registered substance.

Moreover, in the dataset, short-term toxicity to fish was not provided since the tonnage band (1 -10 tonnes/year) does not require that endpoint.

CLP Classification proposal

It is proposed to compare submission substance dataset to CLP environmental criteria laid down in CLP Regulation (including 2nd Adaptation to Technical Progress, Com Reg No 286/2011).

Acute aquatic hazard: not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.

Chronic aquatic hazard: not classified. Reasoning: adequate chronic toxicity data are not available, lowest acute E(L)C50 value higher than 100 mg/L.