Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene

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:

Not specified

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: <0 °C
- Boiling point: 258 °C
- Vapour pressure: Not measured
- Water solubility (under test conditions): Not measured
OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: 8 % after 28 day
- Other:

Analytical monitoring:

not specified

Details on sampling:

Test Levels: Control, 1,000, 5,000 and 10,000 mg/L

Vehicle:

no

Details on test solutions:

The test substance was directly added to the dilution water and no solvent was used.

Test organisms (species):

Pimephales promelas

Details on test organisms:

Test Organisms: Source - Aquatic Research Organisms, Hampton, New Hampshire;
Age- Juvenile;
Length - not determined;
Wet weight - 0.41 g;
Loading rate - 0.27 g/L;
Pre-treatment - none, fish were acclimated to the test conditions for 14 days prior to start of test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Not post exposure observation period specified.

Hardness:

Water adjusted to a hardness of 172 - 176 mg/L as CaCO3

Test temperature:

Test Temperature (ºC) - 22 + 1

pH:

pH - 7.2 to 8.0

Dissolved oxygen:

DO (% Saturation) - 92 to 104%

Salinity:

Not applicable

Nominal and measured concentrations:

The static acute screening test was conducted using nominal test concentrations

Details on test conditions:

Test System: The static acute screening test was conducted using nominal test concentrations of 1,000 mg/L, 5,000 mg/L and 10,000 mg/L. The test substance was directly added to the dilution water and no solvent was used. The test was conducted in 20 L, polyethylene-lined, glass aquaria that contained 15 L of test solution. 10 fish were used for each test concentration (no replicates were used). Test media was renewed after 48 hours. The fish were not fed during the test.
Dilution Water: Source - Dechlorinated tap water; Hardness - Water adjusted to a hardness of 172 - 176 mg/L as CaCO3;
Analysis - Water was free of measurable quantities of pesticides;
Water chemistry in test: DO (% Saturation) - 92 to 104%; pH - 7.2 to 8.0; Test Temperature (ºC) - 22 + 1
Test Levels: Control, 1,000, 5,000 and 10,000 mg/L

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

A sheen of insoluble material was observed in all non-control test vessels. No other effects are noted.

Results with reference substance (positive control):

No data

Reported statistics and error estimates:

Statistical methods were not used as there were no deaths at the highest test concentration.

Validity criteria fulfilled:

yes

Remarks:

OECD GLP method followed.

Conclusions:

LC50 > 10,000 mg/L

Executive summary:

Study conducted to OECD test guidelines in compliance with GLP. LC50 > 10,000 mg/l. This is significantly higher than the water solubility for the substance, but is considered to be an accurate reflection of toxicity to the substance in the event of release.

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

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, which is rated as reliability 2 because it is a read-across study.

Justification for type of information:

Please refer to IUCLID Section 13 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: <0 °C
- Boiling point: 258 °C
- Vapour pressure: Not measured
- Water solubility (under test conditions): Not measured
OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: 8 % after 28 day
- Other:

Analytical monitoring:

not specified

Details on sampling:

Test Levels: Control, 1,000, 5,000 and 10,000 mg/L

Vehicle:

no

Details on test solutions:

The test substance was directly added to the dilution water and no solvent was used.

Test organisms (species):

Pimephales promelas

Details on test organisms:

Test Organisms: Source - Aquatic Research Organisms, Hampton, New Hampshire;
Age- Juvenile;
Length - not determined;
Wet weight - 0.41 g;
Loading rate - 0.27 g/L;
Pre-treatment - none, fish were acclimated to the test conditions for 14 days prior to start of test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Not post exposure observation period specified.

Hardness:

Water adjusted to a hardness of 172 - 176 mg/L as CaCO3

Test temperature:

Test Temperature (ºC) - 22 + 1

pH:

pH - 7.2 to 8.0

Dissolved oxygen:

DO (% Saturation) - 92 to 104%

Salinity:

Not applicable

Nominal and measured concentrations:

The static acute screening test was conducted using nominal test concentrations

Details on test conditions:

Test System: The static acute screening test was conducted using nominal test concentrations of 1,000 mg/L, 5,000 mg/L and 10,000 mg/L. The test substance was directly added to the dilution water and no solvent was used. The test was conducted in 20 L, polyethylene-lined, glass aquaria that contained 15 L of test solution. 10 fish were used for each test concentration (no replicates were used). Test media was renewed after 48 hours. The fish were not fed during the test.
Dilution Water: Source - Dechlorinated tap water; Hardness - Water adjusted to a hardness of 172 - 176 mg/L as CaCO3;
Analysis - Water was free of measurable quantities of pesticides;
Water chemistry in test: DO (% Saturation) - 92 to 104%; pH - 7.2 to 8.0; Test Temperature (ºC) - 22 + 1
Test Levels: Control, 1,000, 5,000 and 10,000 mg/L

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

A sheen of insoluble material was observed in all non-control test vessels. No other effects are noted.

Results with reference substance (positive control):

No data

Reported statistics and error estimates:

Statistical methods were not used as there were no deaths at the highest test concentration.

Validity criteria fulfilled:

yes

Remarks:

OECD GLP method followed.

Conclusions:

LC50 > 10,000 mg/L

Executive summary:

Study conducted to OECD test guidelines in compliance with GLP. LC50 > 10,000 mg/l. This is significantly higher than the water solubility for the substance, but is considered to be an accurate reflection of toxicity to the substance in the event of release.

Description of key information

Short term toxicity to fish

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

10 000 mg/L

Additional information

Read across to CAS 36878 -20 -3. Study conducted to OECD test guidelines in compliance with GLP. LC50 > 10,000 mg/l. This is significantly higher than the water solubility for the substance, but is considered to be an accurate reflection of toxicity to the substance in the event of release.

This substance has been supported under Environmental Protection Agency’s (EPA’s) High Production Volume (HPV) Challenge Program. The American Chemical Councils RAPA Panel, has derived a “Substituted Diphenylamines” category of chemicals for this substance, please refer to EPA reference 201-14700A located at

 

http://www.epa.gov/hpv/pubs/summaries/subdipha/c13378rt.pdf

 

Relying on several factors specified in EPA’s guidance document on “Development of Chemical Categories in the HPV Challenge Program,” in which use of chemical categories is encouraged, the chemicals constitute a chemical category on the following basis:

 

Structural Similarity. A key factor supporting the classification of these chemicals as a category is their structural similarity (see Figure 1). All share a common starting material; Diphenylamine (Benzenamine, N-phenyl-, CAS# 122-39-4), a common synthetic pathway, and all compounds in this category are diamines with various substitutions.

 

Similarity of Physicochemical Properties. The similarity of the physicochemical properties of these materials parallels their structural similarity. All are off-white to light brown solids or viscous liquids intended for use as antioxidants in finished rubber articles or as antidegradant additives that extend the useful life of heavy-duty industrial functional fluids used in high-speed, high-temperature and/or high-load applications. As a class, these amine-based antidegradant compounds are less migratory (more polymer-bound) and less staining than the Substituted p-Phenylenediamine antidegradants. The use of these materials requires that they be stable under high temperatures. Their low volatility is due to their low vapor pressure, highly viscous or solid form. The existing information for these materials indicates that they have low water solubility and high flash points.

 

Fate and Transport Characteristics. Members of this category have been shown to be not readily biodegradable, so additional testing is not needed. The lack of water solubility of the members of this category makes hydrolysis testing unnecessary. These materials have been shown not to partition to water or air if released into the environment due to their low water solubility and low vapor pressure.

 

Toxicological Similarity. Review of existing published and unpublished test data for Substituted Diphenylamines shows the aquatic and mammalian toxicity among the materials within this category are similar.

 

Aquatic Toxicology. Data on acute fish toxicity, acute invertebrate toxicity, and alga toxicity were reviewed. With increasing molecular weight, the toxicity to aquatic organisms decreases. These materials have high estimated log K_owvalues, such that acute toxicity is not expected at or below their low levels of water solubility. For the purposes of the HPV Program, additional testing was not proposed for the members of this category.

 

Conclusion. Based upon the data reviewed in “Substituted Diphenylamines” category of chemicals, the physicochemical and toxicological properties of the Substituted Diphenylamine category members are similar and follow a regular pattern as a result of that structural similarity. Therefore, the definition of a chemical category has been met, and read across is considered appropriate for the category of chemical.