Glycerides, rape-oil mono-, di- and tri-, hydrogenated

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

Toxicity data from a structurally related source substance (Glycerides, C14-C18 and C 16-C18 unsatd., mono-, di-, and tri- (even numbered), CAS 91052-28-7) are used as read-across in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Both are UVCB substances, formed from the esterification of fatty acids and glycerol, having a high content of C18 fatty acids and to a certain extent C14 and C16 fatty acids. Both are composed of mono- to tri esters (Target substance: monoester: 61.9%, diester<: 29.7%, triester: 3.2%; Source substance: monoester: 20-95%, diester: 5-60%, triester: 0.5-15%). Furthermore, their water solubilities are comparable (< 1 mg/L). Therefore, these two substances are expected to show similar environmental behaviour and comparable degrees of toxicity to aquatic organisms. Based on the above information, the use of data from Glycerides, C14-C18 and C 16-C18 unsatd., mono-, di-, and tri- (even numbered) as read-across for Glycerides, C14-18 mono- and di- is considered justified.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EL0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Description of key information

No effects up to the limit of water solubility (WS < 1 mg/L)

Additional information

No study is available investigating the short-term toxicity of Glyceride, rape oil mono-, di- and tri-, hydrogenated (CAS 91744-94-4) to aquatic invertebrates. Therefore, toxicity data from a structurally related source substance (Glycerides, C14-C18 and C 16-C18 unsatd., mono-, di-, and tri- (even numbered), CAS 91052-28-7) are used as read-across in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Both are UVCB substances, formed from the esterification of fatty acids and glycerol, having a high content of C18 fatty acids and to a certain extent C14 and C16 fatty acids. Both are composed of mono- to tri esters (Target substance: monoester: 61.9%, diester<: 29.7%, triester: 3.2%; Source substance: monoester: 20-95%, diester: 5-60%, triester: 0.5-15%). Furthermore, their water solubilities are comparable (< 1 mg/L). Therefore, these two substances are expected to show similar environmental behaviour and comparable degrees of toxicity to aquatic organisms. Based on the above information, the use of data from Glycerides, C14-C18 and C 16-C18 unsatd., mono-, di-, and tri- (even numbered) as read-across for Glycerides, C14-18 mono- and di- is considered justified.

The acute toxicity of the source substance Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7) to aquatic invertebrates has been evaluated by Salinas (2013). This test was conducted according to OECD 202, under GLP conditions. Daphnia magna was exposed to the substance at a single loading rate of 100 mg/L (nominal, limit test) for 48 hours within a static water regime. At the end of the exposure period, no immobilization was observed. Therefore, the EL50 (48 h) was determined to be > 100 mg/L (nominal, loading rate) indicating that the substance is not harmful to aquatic invertebrates within its limit of solubility in water. Based on the suitability of the read across approach this is also considered to be true for the target substance.