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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish:

This study was designed to assess the toxic effects of the test compound on the Petromyzon marinus (Sea Lamprey) in a 24 hr study period.

The test condition with a pH of 7.5 to 8.2 and test temperature 55 Degree Fahrenheit, Dissolved oxygen levels ranging from 8.6-13.7 parts per million was maintained. The aggregate test animals available, usually six in number, were placed together in a 10-liter glass battery jar containing 5 liters of water. These jars were provided with aeration through standard stone air - breakers and were maintained at a constant temperature by immersion in specially constructed constant temperature troughs. Water temperature was maintained within the limits of +/- 1. 0 degree Farenheit. Four such constant temperature units were utilized, each having a capacity of thirteen 10-liter battery jars. Twelve of these test jars were included with one control jar in each trough. Fish in the control jar were exposed only to the water and physical conditions of the typical test container. The resultant volume in each test Jar varied from 5800 to 6200 cc. Test were conducted for a 24-hour period.

In experiment, no any remarkable effect was noted; thus the no observed effect concentration (NOEC) value of butyl 12-acetoxyoctadec-9-enoate (Cas no.140 -04 -5) in fish[ Petromyzon marinus] in a 24 hr study was considered to be 5 mg/L.

Short term toxicity to aquatic invertebrates

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, the short term toxicity on aquatic invertebrates was predicted for butyl 12-acetoxyoctadec-9-enoate (CAS: 140-04-5). EC50 value was estimated to be 76.61 mg/L on the basis of mobility for Daphnia magna for 48 hrs duration.

Thus,from the valuesbutyl 12-acetoxyoctadec-9-enoatewas considered to be toxic to aquatic invertebrate but as it was readily biodegradable in nature hence,butyl 12-acetoxyoctadec-9-enoate (140-04-5)was considered to be not classified as per the CLP regulations.

Toxicity to aquatic algae and cyanobacteria

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, the short term toxicity on aquatic algae and cyanobacteria was predicted for target substance butyl 12-acetoxyoctadec-9-enoate (CAS no. 140 -04 -5). EC50 value was estimated to be 45mg/l for Pseudokirchneriella subcapitata for 72 h duration on the basis of effects on growth rate. Based on this value it can be concluded that the substance butyl 12-acetoxyoctadec-9-enoate is considered to be toxic to aquatic organisms Since the test chemical is readily biodegradable in nature, chemical butyl 12-acetoxyoctadec-9-enoate can be considered to be non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

 

Additional information

Short-term toxicity to fish:

Two studies including experimental results for short term fish toxicity endpoint of test substancebutyl 12-acetoxyoctadec-9-enoate(CAS no.140-04-5) with relevant read across which is structurally similar to target were summarized as follows:

 

First experimental study (fromSpec.Sci.Rep.Fish.No.207, Fish Wildl.Serv., U.S.D.I., Washington, DC:157 p.)for target chemical suggest study was designed to assess the toxic effects of the test compound on the Petromyzon marinus (Sea Lamprey) in a 24 hr study period.

The test condition with a pH of 7.5 to 8.2 and test temperature 55 Degree Fahrenheit, Dissolved oxygen levels ranging from 8.6-13.7 parts per million was maintained. The aggregate test animals available, usually six in number, were placed together in a 10-liter glass battery jar containing 5 liters of water. These jars were provided with aeration through standard stone air - breakers and were maintained at a constant temperature by immersion in specially constructed constant temperature troughs. Water temperature was maintained within the limits of +/- 1. 0 degree Farenheit. Four such constant temperature units were utilized, each having a capacity of thirteen 10-liter battery jars. Twelve of these test jars were included with one control jar in each trough. Fish in the control jar were exposed only to the water and physical conditions of the typical test container. The resultant volume in each test Jar varied from 5800 to 6200 cc. Test were conducted for a 24-hour period.

In experiment, no any remarkable effect was noted; thus the no observed effect concentration (NOEC) value of butyl 12-acetoxyoctadec-9-enoate (Cas no.140 -04 -5) in fish[ Petromyzon marinus] in a 24 hr study was considered to be 5 mg/L. Based on the value thebutyl 12-acetoxyoctadec-9-enoatewas considered to be non toxic to fish hence, it was considered to be not classified as per the CLP regulation.

Above aquatic study is supported by read across chemical Bis(2-ethylhexyl) adipate (Cas no.103-23-1). Short term toxicity to fish study was carried out for 96 hrs. according to OECD Guideline 203 (Fish, Acute Toxicity Test). for chemical Bis(2-ethylhexyl) adipate (Cas no.103-23-1). Based on effect on mortality of the fish, the 96 hr LC50 value was determined to be >50 mg/l. Based on the value the Bis(2-ethylhexyl) adipate was considered to be toxic to fish but as it was readily biodegradable in nature hence, Bis(2-ethylhexyl) adipate was considered to be not classified as per the CLP regulations. (J-CHECK database; 2017)

Thus all above available studies gives the final conclusion as target substancebutyl 12-acetoxyoctadec-9-enoate(Cas no.140-04-5) is expected to be non toxic to fish and thus not consider for the aquatic classification as per the CLP criteria.

Short term toxicity to aquatic invertebrates

Short term toxicity to aquatic invertebrates was summarizes with one predicted data and two experimental studies for read across which was 50-60 % structural similar are as follows.

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, the short term toxicity on aquatic invertebrates was predicted for butyl 12-acetoxyoctadec-9-enoate (CAS: 140-04-5). EC50 value was estimated to be 76.61 mg/L on the basis of mobility for Daphnia magna for 48 hrs duration.

Test was performed in Daphnia magna for 48 hrs in read across Bis(2-ethylhexyl) adipate (103-23-1) which is 50-60 % structural similar with target from J-check, 1999 according to OECD guideline 202. After 48 hrs, the EC 50 value for Bis(2-ethylhexyl) adipate (103-23-1) was determined to be >50 mg/l .

Thus, based on the above weight of evidences, from predictions and read across studies it is concluded that butyl 12-acetoxyoctadec-9-enoate (CAS: 140-04-5) can be considered to be toxic to aquatic invertebrates but as it was readily biodegradable in nature and hence can be considered to be not classified as per CLP regulation.

Toxicity to aquatic algae and cyanobacteria

1 predicted data for the target chemical butyl 12-acetoxyoctadec-9-enoate (CAS no. 140-04-5) which is supported further by total 2 weight of evidence studies (from authoritative database and secondary source) for its closest read across substance with logKow as the primary descriptor were reviewed for the toxicity to aquatic algae and cyanobacteria end point which are summarized as below:

 

Short term toxicity on aquatic algae and cyanobacteria of target chemical butyl 12-acetoxyoctadec-9-enoate (CAS no. 140 -04 -5) is predicted using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances (2017). EC50 value was estimated to be 45mg/l for Pseudokirchneriella subcapitata for 72 h duration on the basis of effects on growth rate. Based on this value it can be concluded that the substance butyl 12-acetoxyoctadec-9-enoate is considered to be toxic to aquatic organisms. Since the test chemical is readily biodegradable in nature, chemical butyl 12-acetoxyoctadec-9-enoate can be considered to be non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

 

In a supporting study of read across chemical Bis (2 -ethylhexyl) adipate (CAS no. 103 -23 -1)from authoritative database (J-CHECK, 2016), short term toxicity to green algae study was carried out for 72 hrs. The study was performed according to OECD Guideline 201 (Alga, Growth Inhibition Test). The study was based on the effects of the read across compound Bis (2 -ethylhexyl) adipate (CAS no. 103 -23 -1) on green algae in a static fresh water system. Based on effect on growth rate and AUG of the test organism green algae, the 72 hr EC50 and NOEC value was determined to be > 50 and 50 mg/l, respectively. Thus, based on the EC50 value, it can be concluded that the substance Bis (2 -ethylhexyl) adipate is considered to be toxic to aquatic organisms. Since the test chemical is readily biodegradable in nature, chemical Bis (2 -ethylhexyl) adipate can be considered to be non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

 

For another read across chemical Dibutyl adipate (CAS no. 105 -99 -7), short term toxicity to Selenastrum capricornutum (algae) study was carried out for 72 hrs according to OECD Guideline 201 (Alga, Growth Inhibition Test) (OECD SIDS Initial Assessment Report, 1996). The study was performed. The study was based on the effects of the read across compound Dibutyl adipate (CAS no. 105 -99 -7) on Selenastrum capricornutum in a static fresh water system. Selenastrum capricornutum ATCC 22662 was used as test organism. Analytical monitoring was not done. 5 nominal concentrations (1 -5 mg/l) of test chemical was used in the study. Stock solution was prepared with DMSO (100 mg/l). Controls with and without this vehicle were taken for the test. Based on the effect on biomass of the test organism Selenastrum capricornutum, the72hr-NOEC and EC50 values of Dibutyl adipate (CAS No.105 -99 -7) was determined as2.8 and 2.0mg/L, respectively.Thus, based on the EC50 value, it can be concluded that the substance Dibutyl adipate is considered to be toxic to aquatic organisms. Since the test chemical is readily biodegradable in nature, chemical Dibutyl adipate can be considered to be non-toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

 

Thus, based on the overall reported results for target chemicalbutyl 12-acetoxyoctadec-9-enoate(OECD QSAR toolbox version 3.4 and EPI suite, 2017) and for its read across substance (from authoritative database and secondary source), it can be concluded that the test substance butyl 12-acetoxyoctadec-9-enoate can be considered as non-toxic to aquatic environment and thus can be considered to be not classified as per the CLP classification criteria.