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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Apr - 26 Apr 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (no data on number of fish, only two concentrations tested, no analytics)

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

Deviations:

yes

Remarks:

, only two concentrations tested

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Samples for analytical verification were collected at t=0 and after 24 hours from the test solution at 3000 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: As the test substance is poorly water soluble, it was weighed and added directly into the test vessels and then mixed for 10 seconds with Ultraturrax.
- Controls: yes

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Westaquarium, delivery on 07 December 1990

ACCLIMATION
- Type and amount of food: Altromin 1413, specification of A 1410, identical to A 1413 but rough pellets instead of grinded
- Health during acclimation (any mortality observed): <0.1% mortality observed one week before the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

22.5 - 23.5 °C

pH:

7.8 - 8.2 (measured every 24h)

Dissolved oxygen:

63-98% air saturation value

Nominal and measured concentrations:

Nominal concentrations: 0, 3000, 10000 mg/L
Measured concentrations: the 3000 mg/L concentration was measured after 0 and 24 hours: 2813 mg/L CSB (0 h) and 313 mg/L CSB (24h)

Details on test conditions:

TEST SYSTEM
- Test vessel: Test basins
- Renewal rate of test solution: semistatic, but renewal intervals not mentioned
- Intervals of water quality measurement: 0, 24, 48, 72 and 96 hours


EFFECT PARAMETERS MEASURED: mortality after 6, 24, 48, 72 and 96 hours

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Yes, after 24 hours only 313 mg/L CSB was measured in the 3000 mg/L test solution (2813 mg/L CSB was measured at 0h). It is mentioned that the 24 hour value is not describing the real relationships, as a phase separation was observed and no representative sample could be taken
- Effect concentrations exceeding solubility of substance in test medium: Yes. LC values based on nominal values even though concentrations were clearly higher than water solubility of test substance. It can be stated, that no toxicity was observed up to the limit of the water solubility of the test substance under conditions tested.

Sublethal observations / clinical signs:

No toxicity was observed up to the limit of the water solubility of the test substance under conditions tested.

Table 1: Mortality [%]

Concentration [mg/L]	Test duration [h]
	0	6	24	48	72	96
0	0	0	0	0	0	0
3000	0	0	0	0	0	0
10000	0	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The substance is not harmful to fish within its limit of solubility in water.

Reference 2

Endpoint:

short-term toxicity to fish

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: Guideline study with acceptable restrictions (no data on number of fish, only two concentrations tested, no analytics)

Justification for type of information:

Toxicity data from a structurally related source substance (Glycerides, C14-18 and C16-18 unsatd. mono- and di-, CAS 67701-33-1) 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: 30 -65%, diester: 20 -50%, triester: 4 -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, C14-18 and C16-18 unsatd. mono-, di- and tri- as read-across for Glycerides, C14-18 mono- and di- is considered justified.

Reason / purpose for cross-reference:

read-across source

Dissolved oxygen:

63-98% air saturation value

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

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 fish. Therefore, toxicity data from a structurally related source substance (Glycerides, C14-18 and C16-18 unsatd. mono- and di-, CAS 67701-33-1) 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: 30 -65%, diester: 20 -50%, triester: 4 -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, C14-18 and C16-18 unsatd. mono-, di- and tri- as read-across for Glycerides, C14-18 mono- and di- is considered justified.

Two studies evaluating the acute toxicity of Glycerides, C14-18 mono- and di- (CAS No. 67701-33-1) are available. The key study (Guhl, 1992) was conducted according to ISO 7346-1, under GLP conditions. Fish were exposed to two concentrations of test substance (3000 and 10000 mg/L) for 96 hours within a semi-static water regime. After the exposure period, no mortality was observed in any of the treatment groups, or in the control. Therefore, the LC50 (96 h) was determined to be > 10,000 mg/L (nominal concentration). The supporting study (Richterich and Mühlberg, 2001) was performed following ISO 7346-1 as well. Danio rerio was exposed to 100, 1000 and 10000 mg test substance/L within a semi-static water regime. After 96 hours, only one fish died at a concentration of 1000 mg/L and therefore, the LC50 (96 h) was determined to be > 10,000 mg/L. Based on the above information, the use of data from Glycerides, C14-18 and C16-18 unsatd. mono-, di- and tri- as read-across for Glycerides, C14-18 mono- and di- is considered justified.

The study with the source substance (Guhl, 1992) was conducted according to ISO 7346-1, under GLP conditions. Fish were exposed to two concentrations of test substance (3000 and 10000 mg/L) for 96 hours within a semi-static water regime. After the exposure period, no mortality was observed in any of the treatment groups, or in the control. Therefore, the LC50 (96 h) was determined to be > 10,000 mg/L (nominal concentration) indicating that the substance is not harmful to fish 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.