N-nitro-N-(3-methyl-3,6-dihydro-2H-1,3,5-oxadiazin-4-yl)amine

Endpoint summary

Additional information

Summary table of ecotoxicity data of CA 2343 A:

 

Data in mg/l	L(E)C-50	NOEC
Fish acute	> 100^a
Daphnia acute	> 100^a
Algae growth inhibition	16.4	3.2
Activated sludge	> 100
Daphnia chron. growth		56^b

 

^aNot any adverse effects observed until 100 mg/l

^bNOEC overall for Daphnia chronic toxicity tests = 56 mg/l (NOEC_growth= 56 mg/l; NOEC_reprotox= 120 mg/l)

 

Discussions on classification and labeling:

Basically the lowest L(E)C-50 from the different acute aquatic toxicity tests should be used for classification purposes. In case of CA 2343 A, the lowest EC-50 of 8.4 mg/l was obtained by the algal growth inhibition test, biomass formation. However in the same study the EC-50 for growth was determined to be 16.4 mg/l, and growth is being considered as the more significant and therefore preferable parameter. Therefore, the lowest, significant L(E)C-50 of the above shown acute aquatic toxicity tests is the result from the algal growth inhibition test (growth) of EC-50 = 16.4 mg/l. This basically implies a classification of CA 2343 as "acute aquatic toxic cat. 3" under GHS or as "N; R52" under 67/548/ECC (since 10 mg/l < EC-50 < 100 mg/l). However some differentiatons have to be observed when it comes to GHS classification within the EU (so-called CLP regulation) and GHS outside the EU (in this context named OECD-GHS).

GHS within the EU (CLP):

Acute aquatic toxicity: No classification of CA 2343, since CLP does not enforce an acute aquatic toxicity category 3.

Chronic aquatic toxicity: No classification of CA 2343, since NOEC chronic Daphnia and NOEC algal growth > 1 mg/l (note that the algal growth inhibition test acc. to OECD Guideline 201 can be accepted as aquatic chronic toxicity data, as indicated in GHS Chapter 4, Section 4.1.1.6).

OECD-GHS outside the EU (i.e. countries applying acute aquatic toxicity category 3):

Acute aquatic toxicity: CA 2343 is classified as "acute aquatic toxicity category 3", "H402 harmful to aquatic life" (since ErC-50 = 16.4 mg/l).

Chronic aquatic toxicity: No classification of CA 2343, since NOEC chronic Daphnia and NOEC algal growth > 1 mg/l (note that the algal growth inhibition test acc. to OECD Guideline 201 can be accepted as aquatic chronic toxicity data, as indicated in GHS Chapter 4, Section 4.1.1.6).

DSD - Annex VI of Directive 67/548/EEC:

Acute aquatic toxicity: CA 2343 is classified as N, "R52 harmful to aquatic organisms" (since ErC-50 = 16.4 mg/l)

Chronic aquatic toxicity: The current classification of CA 2343 acc. to Annex VI, 67/548/ECC is N; "R52/53 harmful to aquatic organisms, may cause long-term adverse effects in the environment". Basis for this classification obviously is the fact the 10 mg/l < L(E)C-50 < 100 mg/l plus the substance is not readily biodegradable. However, in Annex VI, Section 5.2.1.2, it is stated that classification for chronic aquatic toxicity R53 is not necessary as soon as aquatic long-term studies reveal NOEC > 1 mg/l, which is the case for the Daphnia chronic toxicity study and for the algal growth inhibition test acc. to OECD 201. Therefore it deems to be justified to propose no DSD classification for chronic aquatic toxicity.