Reaction mass of Amines, N-tallow alkyltrimethylenedi-, mono(2-ethylhexanoates), Amines, N-tallow alkyltrimethylenedi-, acetates and n-tallow-1,3-diaminopropane ditallate

Endpoint summary

Description of key information

The ecotoxicity data from source chemicals oleyl and tallow-1,3 -diaminopropanes are read across to the target chemical "Reaction mass of Amines, N-tallow alkyltrimethylenedi-, (2-ethylhexanoates), Amines, N-tallow alkyltrimethylenedi-, acetates and n-tallow-1,3 -diaminopropane ditallate" (R814M). This read across is considered justified because the test substance R814M is the salt of tallow-1,3 -diaminopropane (CAS no 1219010 -04 -4) and a mixture of tall oil fatty acids, 2 -ethylhexoic and acetic acid and under environmental conditions R814M is expected to be for a large extent dissociated and any ecotoxicity observed is not expected to come from tall oil fatty acid or 2 -ethylhexanoic acid but from the free tallow-1,3 -diaminopropane. This expectation is supported by ecotoxicity data available for these substances. Where no effects (NOEL>=100 mg/L) were observed for the WAF of tall oil fatty acid to algae and daphnids and for 2 -ethyl hexanoic acid the lowest NOEC (21d daphnia) was 25 mg/L (ECHA),aquatic ecotoxicity data in the range of 0.1 - 0.5 mg/L were found for tallow-1,3 -diaminopropane when tested in natural riverwater. Tallow-1,3 -diaminopropane is thus about two orders of magnitude more ecotoxic than tall oil fatty acid and 1 -ethylhexanoic acid.

Therefore available ecotoxicity data on alkyl-1,3 -diamines were included in the dataset of R814M and as a worst-case used for risk assessment. To support the read across an algae and acute daphnia test has been performed with R814M. These results are used for C&L of R814M.

Results from oleyl and tallow-1,3 -diaminopropanes were recalculated to R814M using the tallow-1,3 -diaminopropanes content in R814M of 52.2% resulting in the following values for the different endpoints:

• Short term fish: 96h LC50 is 0.287 mg/L (Read across);
• Long term fish: There are no long term fish test data available
• Short term aquatic invertebrates (daphnia): 48h EC50 is 0.556 mg/L (Read across)
• Long term aquatic invertebrates (daphnia): 21d EC10/NOEC is 0.192 mg/L (Read across)
• Toxicity to aquatic alga: 21d EC10/NOEC is 0.36 mg/L (Read across)

• Toxicity to microorganisms: EC50 is 126.4 mg/L (Read across)

Additional information

There are two aquatic ecotoxicity tests available with "Reaction mass of Amines, N-tallow alkyltrimethylenedi-, (2-ethylhexanoates), Amines, N-tallow alkyltrimethylenedi-, acetates and n-tallow-1,3 -diaminopropane ditallate" (R814M). An acute daphnia test according to OECD 202 and an algae test according to OECD 201. These studies were performed to serve as bridging studies in the read across of the available ecotoxicity studies from tallow-1,3 -diaminopropane to R814M and can be used for C&L.

Read across from source substance tallow-1,3 -diaminopropane to target substance R814M is considered justified because the test substance R814M is the salt of tallow-1,3 -diaminopropane (CAS no 1219010 -04 -4) and a mixture of tall oil fatty acids, 2 -ethylhexoic and acetic acid and under environmental conditions R814M is expected to be for a large extent dissociated and any ecotoxicity observed is not expected to come from tall oil fatty acid or 2 -ethylhexanoic acid but from the free tallow-1,3 -diaminopropane. This expectation is supported by ecotoxicity data available for these substances. Where no effects (NOEL>=100 mg/L) were observed for the WAF of tall oil fatty acid to algae and daphnids and for 2 -ethyl hexanoic acid the lowest NOEC (21d daphnia) was 25 mg/L (ECHA), aquatic ecotoxicity data in the range of 0.1 - 0.5 mg/L were found for tallow-1,3 -diaminopropane when tested in natural riverwater. Tallow-1,3 -diaminopropane is thus about two orders of magnitude more ecotoxic than tall oil fatty acid and 1 -ethylhexanoic acid.

Therefore available ecotoxicity data on alkyl-1,3 -diamines were included in the dataset of R814M and as a worst-case used for classification and risk assessment.

Short term fish: 96h LC50 for R814M is 0.287 mg/L (Read across);

For alkyl-1,3 -diaminopropanes, seven acute toxicity tests with fish are available for various alkyl-1,3 -diaminopropanes with C12 -18 chains (all reliability 2) which were used for read across to tallow-1,3 diamino propane. The available fish tests reveal a comparable toxicity for the diamines with alkyl chain lengths ranging from C12 to C18, independent of the alkyl chain length. The geometric mean LC50 for all 7 alkyl-1,3 -diaminopropane fish tests has been calculated to be 0.150 mg/L.

For one of the salts of R814M, i.e. tallow-1,3 -diaminopropane acetate (CAS no 61791 -54 -6) there is acute fish test available. This study is of a similar quality as the other alkyl-1,3 -diaminopropane studies. The observed 96h LC50 of 0.150 mg/L of the acetate salt of tallow-1,3 -diaminopropane is exactly the same as the geometric mean derived for the alkyl-1,3 -diaminopropanes. Considering the comparable quality of the studies and similar test results the geometric mean of 0.150 mg/L as calculated for the alkyl-1,3 -diaminopropanes is used for R814M.

R814M consists for 52.2% out of Tallow-1,3 -diaminopropane and because the amine fraction is considered to be the toxic fraction the geometric mean LC50 of 0.150 mg/L should be corrected to 0.287 mg/L

Long term fish: There are no long term fish test data available for R814M

Short term aquatic invertebrates (daphnia): 48h EC50 for R814M is 0.556 mg/L (Read across)

One short term daphnia test according to OECD 202 has been performed with R814M. This test resulted in a 48h EC50 (semi-static) of 0.0482 mg R814M /L (95% CL: 0.0430 – 0.0511). This result is in good agreement with the EC50 range observed for oleyl-1,3 -diaminopropane in the acute daphnia study from CECA (1999) of 0.025 - 0.048 mg/L and confirms that the toxicity observed for R814M must originate from the alkyl-1,3 -diaminopropane fraction in this substance. Read across assuming as a worst-case that the alkyl-1,3 -diaminopropane fraction in R814M is for 100% the reason for the ecotoxicity of R814M is considered justified.

For oleyl-1,3 -diaminopropane there is a long term daphnia test available (OECD 211, river water test, reliability 1) which resulted in a NOEC for reproduction is 1000 µg/L based on the test substance (100% a.i). The NOEC and EC50 for oleyl-1,3 -diaminopropane for parental mortality are resp. 100  and 290 µg/L. The effects are expressed as nominal values because the tests were performed with river water as they are intended to be used in an evaluation of the environmental risks based on the Bulk approach. Recalculating these results to R814M using the tallow-1,3 -diaminopropane content of 52.2% in R814M gives a NOEC for reproduction of 1.92 mg/L and a NOEC and EC50 for parental mortality of 0.192 and 0.556 mg/L.

The NOEC for parental mortality of 0.192 mg/L will as a worst-case be used as Key value for Risk assessment.

The river water test results are in general less suitable for C&L, the result of the short term daphnia test with R814M of 0.0482 mg/L (95% CL: 0.0430 – 0.0511) is therefore use for this purpose.

Long term aquatic invertebrates (daphnia): 21d EC10/NOEC for R814M is 0.192 mg/L (Read across)

See short term aquatic invertebrates. 

Toxicity to aquatic alga: 21d EC10/NOEC for R814M is 0.36 mg/L (Read across)

One algae test according to OECD 201 has been performed with R814M. This test resulted in a 72h ErC50 and ErC10 of respectively 0.0554 (95% CL: 0.0430 – 0.0511) and 0.0188 (95% CL: 0.0101 – 0.0255) mg R814M/L. This result is in good agreement with the ErC10 and ErC50 observed for tallow-1,3 -diaminopropane in the algae study from Akzo (2000) of respectively 0.088 and 0.052 mg/L (recalculated to R814M) and confirms that the toxicity observed for R814M must originate from the alkyl-1,3 -diaminopropane fraction in this substance. Read across assuming as a worst-case that the alkyl-1,3 -diaminopropane fraction in R814M is for 100% the reason for the ecotoxicity of R814M is considered justified.

For oleyl-1,3 -diaminopropane there is one algae study available (OECD 201, river water test, reliability 1)which resulted in an ErC10 and ErC50 of respectively 0.188 and 0.507 mg/L.

Recalculating these results to R814M using the tallow-1,3 -diaminopropane content of 52.2% in R814M gives a ErC10 and ErC50 of respectively 0.360 and 0.97 mg/L. These ErC values of 0.360 and 0.97 mg/L will be as a worst-case be used as Key value for risk assessment.

The river water test results are in general less suitable for C&L, the result as observed in the algae study of 0.0554 mg/L with R814M is therefore used for C&L.

Toxicity to microorganisms: EC50 for R814M is 126.4 mg/L (Read across)

The lowest 3h EC50 for microorganisms as observed for an alkyl-1,3 -diaminopropane in an OECD 209 test is 66 mg/L for oleyl-1,3 -diaminopropane (7173 -62 -8). This result is recalculated to R814M using the tallow-1,3 -diaminopropane content of 52.2% in R814M. This results in a realistic worst-case EC50 for microorganisms of 126.4 mg/L.