4-nitrotoluene

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

other: only abstract available

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

yes (incl. QA statement)

Test organisms (species):

Daphnia magna

Validity criteria fulfilled:

not specified

Executive summary:

MITI, 1998 (only abstract available)

Effect concentrations

Species: Daphnia magna

Exposure duration : 21 d
Endpoint : EC50
Effect concentration : 5.41 mg/L
Basis for concentration : nominal
Remarks (e.g. 95% CL) : 95 % CL: 4.00 - 8.00 mg/L
Exposure duration : 21 d
Endpoint : NOEC
Effect concentration : 2 mg/L
Basis for concentration : nominal

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

other: OECD SIDS

Adequacy of study:

other information

Reliability:

other: OECD SIDS

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is a summary entry for the OECD SIDS

Principles of method if other than guideline:

OECD SIDS

GLP compliance:

not specified

OECD SIDS (2003):

 

In a reproduction test with Daphnia magna a 21 d-NOEC of 0.7 mg/L was obtained. In this study only nominal concentrations are given, as it was taken into account that 4-nitrotoluene was stable in a preliminary test (Canton et al., 1985). The second available test shows with Daphnia magna a 21 d-NOEC (reproduction) nominal of 1 mg/L (Slooff and Canton, 1983). In a non-guideline study with the non-standard test species, the freshwater snail Lymnaea stagnalis, a 40 d-NOEC of 0.32 mg/L was determined for the endpoint reproduction (Slooff and Canton, 1983). The publication does not provide many details of the test, but states the basic test parameters and thus is considered valid. Chronic toxicities have also been measured for 2 other aquatic invertebrates: for the aquatic insect larvae of Culex pipiens a 25 d-NOEC of 3.2 mg/L (development), for the hydrozoan Hydra oligactis a 21 d-NOEC of 10 mg/L (specific growth rate; Slooff and Canton, 1983).

Validity criteria fulfilled:

not specified

Executive summary:

OECD SIDS (2003):

 

In a reproduction test with Daphnia magna a 21 d-NOEC of 0.7 mg/L was obtained. In this study only nominal concentrations are given, as it was taken into account that 4-nitrotoluene was stable in a preliminary test (Canton et al., 1985). The second available test shows with Daphnia magna a 21 d-NOEC (reproduction) nominal of 1 mg/L (Slooff and Canton, 1983). In a non-guideline study with the non-standard test species, the freshwater snail Lymnaea stagnalis, a 40 d-NOEC of 0.32 mg/L was determined for the endpoint reproduction (Slooff and Canton, 1983). The publication does not provide many details of the test, but states the basic test parameters and thus is considered valid. Chronic toxicities have also been measured for 2 other aquatic invertebrates: for the aquatic insect larvae of Culex pipiens a 25 d-NOEC of 3.2 mg/L (development), for the hydrozoan Hydra oligactis a 21 d-NOEC of 10 mg/L (specific growth rate; Slooff and Canton, 1983).

Reference 3

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

other: BUA report

Adequacy of study:

other information

Reliability:

other: BUA report

Rationale for reliability incl. deficiencies:

other: no reliability is given as this is a summary entry for the BUA report

Principles of method if other than guideline:

BUA report

GLP compliance:

not specified

Test organisms (species):

other: BUA report

BUA report (1989):

 

In studies on the effect of p-nitrotoluene on the fresh water polyp Hydra oligactis a 21d test (semistatic system) showed a no-effect concentration (NOEC) on growth of 10 mg/L (Slooff & Canton, 1983). In a 21d mortality test with Daphnia magna (semistatic system), p-nitrotoluene showed a no-effect concentration (NOLC) of 3.2 mg/L. A 21d reproduction test gave a NOEC of 1 mg/L (Slooff & Canton, 1983). The following data are given on the chronic effects of nitrotoluenes to Daphnia magna (Canton et al. 1985): 21d-LC50 = 3.2, 21d-EC50 (Mortality and Immobility) = 3.2 mg/L, 21d-EC50 (Inhibition of reproduction) = 1.8 mg/L, 21d- NOEC (Inhibition of reproduction) = 0.7 mg/L.

The following figures are given for the highest concentration of p-nitrotoluene without a lethal effect on Culex pipiens and Lymnea stagnalis (Slooff & Canton, 1983):

 

Species	Age	Effect (Duration in days)	NOEC [mg/L]
Culex pipiens	1st larval stage	Mortality (25d)	3.2
		Inhibition of development (25d)	3.2
Lymnaea stagnalis	5 months	Mortality (40d)	10
		Inhibition of reproduction (40d)	0.32
	eggs	Inhibition of hatching rate (7d)	10

Validity criteria fulfilled:

not specified

Executive summary:

BUA report (1989):

 

In studies on the effect of p-nitrotoluene on the fresh water polyp Hydra oligactis a 21d test (semistatic system) showed a no-effect concentration (NOEC) on growth of 10 mg/L (Slooff & Canton, 1983). In a 21d mortality test with Daphnia magna (semistatic system), p-nitrotoluene showed a no-effect concentration (NOLC) of 3.2 mg/L. A 21d reproduction test gave a NOEC of 1 mg/L (Slooff & Canton, 1983). The following data are given on the chronic effects of nitrotoluenes to Daphnia magna (Canton et al. 1985): 21d-LC50 = 3.2, 21d-EC50 (Mortality and Immobility) = 3.2 mg/L, 21d-EC50 (Inhibition of reproduction) = 1.8 mg/L, 21d- NOEC (Inhibition of reproduction) = 0.7 mg/L.

Reference 4

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Insufficiently documented. Test period, endpoint, and other important data not reported.

Principles of method if other than guideline:

no information given

GLP compliance:

not specified

Analytical monitoring:

yes

Test organisms (species):

other aquatic mollusc: Lymnea stagnalis

Test type:

not specified

Water media type:

freshwater

Remarks on exposure duration:

no data given

Dose descriptor:

NOEC

Effect conc.:

0.2 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

not specified

Validity criteria fulfilled:

not specified

Executive summary:

In a study with the non-standard test species, the freshwater snail Lymnaea stagnalis, a NOEC of 0.2 mg/L was determined. Test period, endpoint, and other important data were not reported. (Canton, 1985).

Reference 5

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Basic data given

Principles of method if other than guideline:

other: no guideline followed, see test conditions

GLP compliance:

not specified

Analytical monitoring:

no

Test organisms (species):

other aquatic mollusc: Lymnea stagnalis

Details on test organisms:

5 month old snails from laboratory culture

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

40 d

Test temperature:

20 +/- 1 °C

Details on test conditions:

- 20 Snails per group
- 20 L Test volume per group
- Food: Lettuce
- Circadic illumination
- Culturing medium contains per 1 l bidistilled water: 100 mg/L NaHCO3, 200 mg/L CaCl2*2H2O, 20 mg/L KHCO3, 180 mg/L MgSO4*7H2O

Duration:

40 d

Dose descriptor:

NOEC

Effect conc.:

0.32 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

reproduction

Duration:

40 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mortality

Validity criteria fulfilled:

not specified

Executive summary:

Slooff, 1983 (also cited in OECD SIDS,2003):

In a non-guideline study with the non-standard test species, the freshwater snail Lymnaea stagnalis, a 40 d-NOEC of 0.32 mg/l was determined for the endpoint reproduction (Slooff and Canton, 1983). The publication does not provide many details of the test, but states the basic test parameters and thus is considered valid.

Reference 6

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: National Guideline study with acceptable restrictions; only basic data given

Principles of method if other than guideline:

other: NEN 6502: Determination of chronic toxicity to Daphnia magna (1980), Dutch Standardization Organization, Rijswijk, The Nederlands

GLP compliance:

not specified

Specific details on test material used for the study:

Name of test material (as cited in publication): 4-nitrotoluene
Analytical purity: > 98%

Analytical monitoring:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

- all daphnids used were <24 h old at the start of the experiment

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

21 d

Hardness:

200 mg/L CaCO3

Test temperature:

20 ± 0.5 °C

pH:

8.4 ± 0.1

Dissolved oxygen:

medium was saturated with air prior to use

Details on test conditions:

- test was carried out in a room that was illuminated 12 h/day
- a synthetic test medium was used (NPR 6503,1980)
- daphnids were fed with 3x10^8 (cells/L day) of Chlorella pyrenoidosa.

Duration:

21 d

Dose descriptor:

IC50

Effect conc.:

7 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

immobilisation

Remarks on result:

other: 95% C.L. (6.6-7.5)

Reported statistics and error estimates:

IC50 values were calculated according to Kooyman (1981)

- Mortality in the controls never exceeded 10 %

 

Two other chronic effects are presented in the publications:
1. Population growth:
LRCT(rm) = Lowest rejected concentration tested that significantly (p<0.01)lowered the population growth constant(rm) after 21 days of exposure.
logLRCT(rm) = 1.61 [µmol/L] corresponds to 5.6 mg/L
2. Body length:
LRCT(length) = Lowest rejected concentration tested that significantly (p<0.01)lowered the mean length (L) of animals after 21 days of exposure.
logLRCT(length) = 1.61 [µmol/L] corresponds to 5.6 mg/L

 

The concentrations were determined using Williams´ procedure (Williams, 1971, 1972).

 

Validity criteria fulfilled:

yes

Remarks:

- Mortality in the controls never exceeded 10 %

Executive summary:

Maas-Diepeveen, 1986/Deneer, 1989 carried out a study on Daphnia magna, in semi-static test conditions, following the protocol of the Dutch Standards Organization NEN 6502 (1980). All daphnids used were < 24 h old at the start of the experiments. The study reports the following effect concentration: 21-d IC50: 7 mg/L

Reference 7

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, without detailed documentation, basic data given

Principles of method if other than guideline:

other: in analogy with the OECD 202 proposal 1979

GLP compliance:

no

Specific details on test material used for the study:

Name of test material (as cited in publication): 4-Nitrotoluene
Analytical purity > 99.5 % Purity (Origin: Fluka)

Analytical monitoring:

yes

Details on sampling:

no further data

Test organisms (species):

Daphnia magna

Details on test organisms:

- Daphnias were 1 day old at start of incubation

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

21 d

Test temperature:

19 +/- 1 °C

Details on test conditions:

- 25 organisms per 1 litre of test medium, 2 replicates
- Culturing and test medium: NaHCO3 100 mg/L, CaCl2*2H2O 200 mg/L, KHCO3 20 mg/L, MgSO4*7H2O 180 mg/L
- Food during incubation: Chlorella
- Circadic lighting

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

1.8 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.7 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

reproduction

Validity criteria fulfilled:

not specified

Executive summary:

OECD SIDS (2003):

In a reproduction test with Daphnia magna a 21 d-NOEC of 0.7 mg/L was obtained. In this study only nominal concentrations are given, as it was taken into account that 4-nitrotoluene was stable in a preliminary test (Canton et al., 1985).

Description of key information

For transported isolated intermediates according to REACh, Article 18, this endpoint is not a data requirement. However, data is available for this endpoint and is thus reported under the guidance of "all available data".

 

OECD SIDS (2003):

In a reproduction test with Daphnia magna a 21 d-NOEC of 0.7 mg/L was obtained. In this study only nominal concentrations are given, as it was taken into account that 4-nitrotoluene was stable in a preliminary test (Canton et al., 1985). The second available test shows with Daphnia magna a 21 d-NOEC (reproduction) nominal of 1 mg/L (Slooff and Canton, 1983). In a non-guideline study with the non-standard test species, the freshwater snail Lymnaea stagnalis, a 40 d-NOEC of 0.32 mg/L was determined for the endpoint reproduction (Slooff and Canton, 1983). The publication does not provide many details of the test, but states the basic test parameters and thus is considered valid. Chronic toxicities have also been measured for 2 other aquatic invertebrates: for the aquatic insect larvae of Culex pipiens a 25 d-NOEC of 3.2 mg/L (development), for the hydrozoan Hydra oligactis a 21 d-NOEC of 10 mg/L (specific growth rate; Slooff and Canton, 1983).

BUA report (1989):

In studies on the effect of p-nitrotoluene on the fresh water polyp Hydra oligactis a 21d test (semistatic system) showed a no-effect concentration (NOEC) on growth of 10 mg/L (Slooff & Canton, 1983). In a 21d mortality test with Daphnia magna (semistatic system), p-nitrotoluene showed a no-effect concentration (NOLC) of 3.2 mg/L. A 21d reproduction test gave a NOEC of 1 mg/L (Slooff & Canton, 1983). The following data are given on the chronic effects of nitrotoluenes to Daphnia magna (Canton et al. 1985): 21d-LC50 = 3.2, 21d-EC50 (Mortality and Immobility) = 3.2 mg/L, 21d-EC50 (Inhibition of reproduction) = 1.8 mg/L, 21d- NOEC (Inhibition of reproduction) = 0.7 mg/L.

Maas-Diepeveen, 1986/Deneer, 1989 carried out a study on Daphnia magna, in semi-static test conditions, following the protocol of the Dutch Standards Organization NEN 6502 (1980). All daphnids used were < 24 h old at the start of the experiments. The study reports the following effect concentration: 21-d IC50: 7 mg/L

In a study with the non-standard test species, the freshwater snail Lymnaea stagnalis, a NOEC of 0.2 mg/L was determined. Test period, endpoint, and other important data were not reported. (Canton, 1985).

MITI, 1998 (only abstract available)

Effect concentrations 

Species: Daphnia magna

Exposure duration : 21 d
Endpoint : EC50
Effect concentration : 5.41 mg/L
Basis for concentration : nominal
Remarks (e.g. 95% CL) : 95 % CL: 4.00 - 8.00 mg/L
Exposure duration : 21 d
Endpoint : NOEC
Effect concentration : 2 mg/L
Basis for concentration : nominal