Pentaerythritol

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

September 8 to 29, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Principles of method if other than guideline:

The OECD guideline followed was likely to have been OECD 202 part 2.

GLP compliance:

yes

Remarks:

report states "GLP Compatible"

Analytical monitoring:

not specified

Details on sampling:

Not specified

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: direct dissolution in water

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: daphnia magna
- Strain: not specified
- Source: National Institute for Environmental Studies of Environment Agency
- Age at study initiation (mean and range, SD): not specified
- Weight at study initiation (mean and range, SD): not specified
- Length at study initiation (length definition, mean, range and SD): not specified

- Method of breeding: not specified
- Feeding during test
- Food type: chlorella vulgaris
- Amount: 2x10^7 cells per feeding
- Frequency: once per day


ACCLIMATION
- Acclimation period: not specified
- Acclimation conditions (same as test or not): not specified

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Post exposure observation period:

none

Hardness:

Not specified

Test temperature:

19+/- 1 °C

pH:

Ranged between 7.1 and 7.7 over all of the treatments.

Dissolved oxygen:

Ranged between 6.0 to 9.2 mg/L over all of the treatments.

Salinity:

Not applicable

Conductivity:

Not specified

Nominal and measured concentrations:

Control, 10, 32, 100, 320 & 1000 mg/L (nominal exposure concentrations)

Details on test conditions:

TEST SYSTEM

- Renewal rate of test solution (frequency): renewals were made on days 2, 4, 6, 8, 10, 12, 14, 16, 18 & 20
- No. of organisms per vessel:10
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:dechlorinated tap water
- Intervals of water quality measurement: on renewal of test medium , fresh and spent media


OTHER TEST CONDITIONS
- Adjustment of pH:not specified
- Photoperiod: not specified
- Light intensity: not specified


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2

Adult mortality and juvenile production were monitored daily.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mortality

Details on results:

- Mortality of parent animals: none
- No. of offspring produced per day per female: Control: 55.10; 10 mg/L: 55.25; 32 mg/L: 50.28; 100 mg/L: 54.45; 320 mg/L: 59.75; 1000 mg/L:52.75
- Time to first brood release: 8 days

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

Not specified

The report contains the indivdual reproduction values per vessel per day. Juveniles were first produced on day 8 in all of the control, 10, 32 and 100 mg/L test vessels, in the 320 mg/L treatment juveniles were first produced in two replicates on day 8 and the other two on day 9, in the 1000 mg/L treatment juveniles were first produced in three replicates on day 8 and the other one on day 9.

Mean juvenile production per female in the test and treaments was as follows:

Control - 55.10

10 mg/L - 55.25

32 mg/L - 50.28

100 mg/L - 54.45

320 mg/L - 59.75

1000 mg/L - 52.75

There was no significant difference between the numbers of juveniles produced per female between the control and any of the test treatments.

A small number of dead juveniles was seen during the study, total numbers were as follows:

Control - 1

10 mg/l - 1

32 mg/L - 23

100 mg/L - 2

320 mg/L - 46

1000 mg/L - 22

The number of dead juveniles was not significant compared top the total number of live juveniles produced.

Validity criteria fulfilled:

not specified

Conclusions:

Four replicates, each containing 10 female Daphnia magna, were exposed (under semi-static conditions) to a series of concentrations of pentaerythritol for a 21 day period. There was no adult mortality during the study, therefore the 21 day LC50 was observed to be >1000 mg/L (the highest nominal exposure concentration tested). There were no significant differences in the number of juveniles produced per female in the control and test treatments during the study. Therefore, the no-observed effect concentration based on reproduction was 1000 mg/L (the highest nominal exposure concentration tested).

Executive summary:

Four replicates, each containing 10 female Daphnia magna, were exposed (under semi-static conditions) to a series of concentrations of pentaerythritol for a 21 day period. There was no adult mortality during the study, therefore the 21 day LC50 was observed to be >1000 mg/L (the highest nominal exposure concentration tested). There were no significant differences in the number of juveniles produced per female in the control and test treatments during the study. Therefore, the no-observed effect concentration based on reproduction was 1000 mg/L (the highest nominal exposure concentration tested).

Description of key information

A long term daphnia study has been proposed to assess the toxic effects in aquatic environment in line to REACH guidance annex IX. However, a supportive experimental study is available where the long-term toxicity of pentaerythritol to Daphnia magna showed no adult mortality in 1000 mg/L exposure concentrations of the test substance throughout the 21 day exposure period. The 21 day LC50 was therefore concluded to be >1000 mg/L (the highest nominal exposure concentration tested). There were no significant differences in the number of juveniles produced per female in the control and test treatments during the study. Therefore, the no-observed effect concentration (NOEC) based on reproduction was 1000 mg/L (the highest nominal exposure concentration tested) (Fukuoka, 1993).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1 000 mg/L