Bis(methylcyclohexyl) phthalate

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

vehicle was used

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: GG01
- Purity: 99.9% (GC method)

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A respective amount of test substance and vehicle was added to synthetic freshwater in order to a treatment concnetration of 2 mg/L and a vehicle concentration of 100 mg/L.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Dimethylformamid, HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 100 mg/L

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Japanese rice fish
- Source: Sankyo Suisan Co., Ltd (1 Banchi, 1 Chome, Ichigayata-machi, Shinjuku-ku,)
- Length at study initiation (length definition, mean, range and SD): 1.68 cm (1.51 - 2.48 cm)
- Weight at study initiation (mean and range, SD): 0.072 g (0.026 - 0.230 g)

ACCLIMATION
- Acclimation period: Nov29th,1999 – Jan 24th, 2000. The death rate within 7 days before exposure was below 5%, the individualswhich visually looked healthy and normal were used.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

not specified

Test temperature:

24 ± 1 °C

pH:

6.0 - 8.5

Dissolved oxygen:

> 60% saturation

Nominal and measured concentrations:

Nominal: 2 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Aquaria with 5 L test solution
- Type (delete if not applicable): covered water surface with teflon sheet
- Aeration: no
- Renewal rate of test solution: renewal total amount of test solution every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic freshwater
- Intervals of water quality measurement: The pH was measured at the beginning of test and around the timing of water exchange every 24 hours.

OTHER TEST CONDITIONS
- Photoperiod: 16h light/ 8h dark
- Light intensity: room light

EFFECT PARAMETERS MEASURED: Mortality was recorded after 24, 48, 72 and 96h exposure time.

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

The test substance is not acutely toxic to fish within its limit of solubility in water.

Executive summary:

One acute toxicity study was performed to assess the acute toxicity of dicyclohexyl phthalate to the freshwater fish species Oryzias latipes. The study was conducted under GLP and according to OECD guideline 203. The study was performed in a closed semi-static system. Fish were exposed to the test substance at limit test concentration of 2 mg/L using a vehicle to fascilitate exposure. Test substance analytics confirmed the nominal concentrations. The 96h-LC50 is determined to be > 2 mg/L.

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:

guideline study with acceptable restrictions

Remarks:

vehicle was used

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
The analogue justification document is attached to chapter 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: GG01
- Purity: 99.9% (GC method)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Conclusions:

The test substance is not acutely toxic to fish within its limit of solubility in water.

Executive summary:

One acute toxicity study was performed to assess the acute toxicity of dicyclohexyl phthalate to the freshwater fish species Oryzias latipes. The study was conducted under GLP and according to OECD guideline 203. The study was performed in a closed semi-static system. Fish were exposed to the test substance at limit test concentration of 2 mg/L using a vehicle to fascilitate exposure. Test substance analytics confirmed the nominal concentrations. The 96h-LC50 is determined to be > 2 mg/L.

Description of key information

No toxicity observed within the limit of solubility in water (96h-LC50 > 2 mg/L (nominal, vehicle) for mortality of Oryzias latipes (OECD 203, read across))

Additional information

Since no studies assessing the short-term toxicity of Bis(methylcyclohexyl) phthalate (CAS 27987-25-3) to fish is available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally related source substance Dicyclohexyl phthalate (CAS 84-61-7) was conducted. The analogue justification document is attached to chapter 13.

The study with the read across substance was performed by Japanese environmental agency under GLP according to OECD guideline 203 using Oryzias latipes as test organism (MOE 2000). Dimethylformamid, HCO-40 were used to fascilitate the solubility of the substance in the test solution. A limit test concentration of 2 mg/L was tested. The nominal concentration was varified analytically. The 96h-LC50 value is deternined to be > 2 mg/L. Thus, the substance is not harmful to fish up to its limit of solubility in water. Based on the high structural similarity which leads to similar environmental behaviour and ecotoxicity this conclusion can also be considered true for the target substance Bis(methylcyclohexyl) phthalate.