Registration Dossier
Registration Dossier
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EC number: 252-488-1 | CAS number: 35285-69-9
Endpoint summary
Administrative data
Description of key information
LC50 (96 h) (freshwater) = 6.4 mg/L (geom. mean measured) for Danio rerio (OECD 203) (read-across with propylparaben (CAS No. 94-13-3)) (Kimmel, 2012a)
EC50 (48 h) (freshwater) = 15.4 mg/L (not specified) for Daphnia magna (ISO 6341 15) (read-across with propylparaben (CAS No. 94-13-3)) (Madsen, 2001)
NOErC (72 h) (freshwater) = 2.1 mg/L (nominal) for Pseudokirchneriella subcapitata (OECD 201) (read-across with propylparaben (CAS No. 94-13-3)) (Kimmel, 2012b)
ErC50 (72 h) (freshwater) = 16 mg/L (nominal) for Pseudokirchneriella subcapitata (OECD 201) (read-across withpropylparaben (CAS No. 94-13-3)) (Kimmel, 2012b)
NOEC (28 d) (freshwater) ≥ 20 mg/L (nominal) for activated sludge (OECD 301F) (read-across with propylparaben (CAS No. 94 -13 -3)) (Madsen, 2001)
The long-term test with daphnia magna (OECD 211) revealed a NOEC of 0.25 mg/L. In a fish sexual development test (OECD 234) with Danio rerio the lowest NOEC found was 0.165 mg/L.
Additional information
No studies investigating the aquatic toxicity of sodium propylparaben (CAS No. 35285-69-9) are available. Therefore, toxicity data of the corresponding acid propylparaben (CAS No. 94-13-3) are used as read across.
This read across approach is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach as is explained within the analogue justification in section 13. Except for different cations (hydrogen vs. sodium) the anions of both the source and target substance have identical chemical structures. Since dissociation of the sodium salt under environmental conditions (pH 4 - 9) yields the same ionic species as the acidic form of the substance, this read across can be considered as justified.
One study investigating the short-term toxicity of propylparaben to fish is available. The GLP study was conducted under static conditions according to OECD 203 with Danio rerio (Kimmel, 2012a). The LC50 (96h) was determined to be 6.4 mg/L (geom. mean measured).
Data on the short-term toxicity of proylparaben to aquatic invertebrates are presented in the dossier “Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products” by the Danish Ministry of Environment and Energy (Madsen et al., 2001). Herein, results from a Daphnia magna study according to ISO 634115 are cited. The EC50 (48h) was determined to be 15.4 mg/L.
The toxicity to algae was investigated in a GLP under static conditions according to OECD 201 with Pseudokirchneriella subcapitata (Kimmel, 2012b). This key study resulted in an ErC50 (72h) of 16 mg/L and a NOErC (72h) of 2.1 mg/L.
For the assessment of the toxicity to microorganisms a ready biodegradability study is used to derive a NOEC (Madsen et al., 2001). The substance was applied at a concentration of 20 mg/L in a ready biodegradability test according to OECD guideline 301 F. Within 28 days, the substance attained 91.5% degradation based on O2 consumption. Since no inhibition of the microorganism activity in this study occurred the NOEC (28d) for toxicity to aquatic microorganisms is stated as ≥ 20 mg/L.
The long-term test with daphnia magna (OECD 211) revealed a NOEC of 0.25 mg/L. In a fish sexual development test (OECD 234) with Danio rerio the lowest NOEC found was 0.165 mg/L.
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