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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish:

Short term toxicity of test chemical were studied on the mortality of fish Oryzias latipes (Japanese Medaka). The lethal concentration (LC50) value of test chemical on fish (Oryzias latipes) in a 24 hr and 48 hrs study on the basis of mortality effect was estimated to be >1000 mg/L. Thus considering the value from CLP Criteria for aquatic classification of the substance, it is concluded that test chemical could not exhibit short term toxicity to fish (Oryzias latipes).

Long term toxicity to fish:

The test chemical is not likely to be toxic to fish atleast in the concentration range of 50 mg/l

Short term toxicity to aquatic invertebrate:

1: After the exposure period of 48 hrs, effect of test chemical on the mobility of daphnia magna were studied and determine at > 13 mg/l.

2: After the exposure period of 48 hrs, effect of test chemical on the mobility of daphnia magna was determine at 19 mg/l.

Thus based on the above effect, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

Long term toxicity to aquatic invertebrate:

The test chemical  is not likely to be toxic to invertebrate in long term atleast in the concentration range of 1.5 - 2 mg/l.

Toxicity to microorganisms:

1: Based on the growth rate inhibition of green algae and area under the growth rate, the EC50 was observed at > 56 mg/l and the NOEC value was determine at 46 mg/l.

2: Based on the growth rate inhibition and area under the growth of green algae the EC50 was observed at 150 mg/l and 110 mg/l. Whereas No effect were observed at 31 mg/l.

Thus based on the effects observation on algae, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

Additional information

Short term toxicity to fish:

Summarized result for the toxicity of test chemical on mortality of fish were carried out and mention as below:

Short term toxicity of test chemical were studied on the mortality of fish Oryzias latipes (Japanese Medaka). The lethal concentration (LC50) value of test chemical on fish (Oryzias latipes) in a 24 hr and 48 hrs study on the basis of mortality effect was estimated to be >1000 mg/L. Thus considering the value from CLP Criteria for aquatic classification of the substance, it is concluded that test chemical could not exhibit short term toxicity to fish (Oryzias latipes).

 

First study was supported by the second study from secondary source. Short term toxicity of test chemical were studied on the mortality of fish Oryzias latipes (Japanese Medaka). Test conducted under the static system for 48 hrs. Based on the mortality of fish Oryzias latipes (Japanese Medaka) by the chemical incubation for 24 and 48 hrs, the LC50 was observed at 260 mg/l and 240 mg/l. Thus on the basis of LC50 value, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

Thus on the basis of LC50 value, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Long term toxicity to fish:

Data available for the test chemicals has been reviewed to determine the long term toxicity of fish .The studies are as mentioned below:

 

Long term toxicity study was evaluated for test material according to OECD Guideline 204 (Fish, Prolonged Toxicity Test) for 14 days. The effect concentration for test material after 14 days study on fish was observed to be > 50 mg/l. Thus, it can be concluded that effect concertation value is greater than 50 mg/ L. Thus, comparing this value with the criteria of CLP regulation, test material cannot be classified for long term toxicity for fish.

 

First study was supported by the second. The long term toxicity of test material was evaluated for fish according to OECD 204 prolong toxicity to fish for 14 days. Based on the mortality of fish by chemical, the no observed effect concentration (NOEC) and (EC50) was observed to be > 5 mg/l. On the basis of above effect concentrations, chemical can be considered as non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

 

Thus, based on the above summarized studies, it can be concluded that effect concertation value is greater than 50 mg/ L. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for long term toxicity for fish.

 

Short term toxicity to aquatic invertebrate:

Summarized result for the toxicity of test chemical and structurally and functionally similar read across chemicals, study has been reviewed and mention as below:

 

Short term toxicity study of test chemical on the mobility of daphnia magna were carried out in accordance with the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test conducted under the static system for 48 hrs. After the exposure period of 48 hrs, effect of test chemical on the mobility of daphnia magna were studied and determine at > 13 mg/l. As the test chemical is readily biodegradable in water, thus on that basis chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

First study was supported by the second study from authoritative database. Objective of the study was evaluation of effects of test chemical on daphnia magna. Test carried out in accordance with the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Static system were used. After the exposure period of 48 hrs, effect of test chemical on the mobility of daphnia magna was determine at 19 mg/l. As the test chemical is readily biodegradable in water, thus on that basis chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the above effect, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Long term toxicity to aquatic invertebrate:

 

Data available for the test chemicals and structurally similar read across chemical, study has been reviewed to determine the long term toxicity of test chemical on aquatic invertebrate .The studies are as mentioned below:

 

The long term study of test material on aquatic invertebrate daphnia magna was performed to evaluate its effect on reproduction efficiency of daphnia magna according to OECD Guideline 211 (Daphnia magna Reproduction Test). The EC50 of test material after 21 days was observed to be in the range of 0.55 - 2.1 mg/l. The no effect concentration (NOEC) was observed to be 0.55 mg/l. On the basis of above effect EC50 value chemical can be considered as non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

 

First study was supported by the second study from authoritative study. Long term toxicity of test chemical on invertebrate daphnia magna study was performed for 21 days according to OECD Guideline 211 (Daphnia magna Reproduction Test). Based on the effect observation on the daphnia magna after exposure period of 21 days, the EC50 was observed to be 1.5 mg/l, the NOEC was observed to be 0.48 mg/l. On the basis of above value it can be considered that the chemical was non-toxic to fish and cannot be classified as hazardous as per the CLP criteria.

 

Thus based on the above effects, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Toxicity to aquatic algae and cyanobacteria:

Summarized result for the toxicity of test chemical were studied by observing the effect on the growth rate inhibition of aquatic algae. The studies are reviewed and mention as below:

 

Short term toxicity study of test chemical to algal growth inhibition test was carried out for 72hrs. Test conducted according to the OECD Guideline 201 (Alga, Growth Inhibition Test). Test conducted under the static system. Based on the growth rate inhibition of green algae and area under the growth rate, the EC50 was observed at > 56 mg/l and the NOEC value was determine at 46 mg/l. As the chemical was readily biodegradable in water, thus chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Similar short term toxicity study to algal growth inhibition test was carried out for 72hrs. Test conducted according to the OECD Guideline 201 (Alga, Growth Inhibition Test). Test conducted under the static system for 72 hrs. Based on the growth rate inhibition and area under the growth of green algae the EC50 was observed at 150 mg/l and 110 mg/l. Whereas No effect were observed at 31 mg/l. Thus on the basis of EC50 value, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the effects observation on algae, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

Toxicity to microorganisms:

The effect of test chemical on methanogenesis and the microbial reductive dechlorination of hexachlorobenzene (HCB) was examined using three anaerobic, HCB-dechlorinating mixed cultures, one glucose fed and two lactate fed, that were derived from contaminated estuarine sediments. The two lactate-fed cultures differed significantly in their metabolic activity, especially with respect to the rate and extent of HCB reductive dechlorination. The objective of the study was to screen and select biologically compatible surfactants for use in subsequent research on surfactant-enhanced bioavailability of sorbed-phase chlorinated organic contaminants. The effect of test chemical on the reductive dechlorination of hexachlorobenzene (HCB) was examined using three anaerobic HCB-dechlorinating enriched cultures. Based on the above effects observations, the EC was determine to be 50 mg/l.

Thus based on the overall data, chemical consider to be nontoxic and not classified as per the CLP classification criteria.