Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

FISH

Ozretich et. al (1983) performed a 96 hr flow-through test on the saltwater fish Cymatogaster aggregata. This test was performed to a standard guideline (ASTM). The LC50 was determined to be 0.51 mg/L. This test is used as the key study for the fulfilment of the short term toxicity to fish endpoint.

Adams et al. (1995) performed several 96 h tests (static and flow-though) on Sheephead minnows, Fathead minnows, Bluegill sunfish and Rainbow trout. The most conservative result came from Sheephead minnows (Cyprinodon variegatus).This test closely followed a standard guideline (OECD 203). The LC50 was determined to be >0.68 mg/L.

Gledhill et al. (1980) performed 96 -hour static tests on four fish species (fathead minnow, bluegill, rainbow trout and sheepshead minnow). LC50s ranged from 1.7 - 5.3 mg/L. The studies are from a review article and there is limited detail on the methods used.

A number of other proprietary studies are available and are used as supporting studies. These report LC50 values of 1.7 - 3.3 mg/L for a variety of fish species.

Rhodes et al. (1995) performed a chronic toxicity test on the freshwater fish Oncorhynchus mykiss. This was a GLP test and was equivalent/similar to the guidelines EPA 797.1600 (U. S. EPA Toxic Substances Control Act 40 CFR, Part 797.1600 [as modified in Testing Consent Agreement 40 CFR, Part 799], and the ASTM Standard Guide for Conducting Early Life-Stage Toxicity Tests with Fishes). The test showed no effects on hatchability, survival, or growth for benzyl butyl phthalate at any of the test concentrations (up to 0.20 mg/L). This test is used as a key study.

Hicks (2008) performed a two-generation reproduction and early-life stages test upon the freshwater fishPimephales promelasin accordance with GLP and based upon multiple guidelines.Endpointsthat were examined quantitatively included F0/F1 survival, body length of males and females, body weight of males and females, cumulative F0 fecundity, number of spawns, percent fertility, percent hatchability, and plasma vitellogenin in F1 males and females. No statistically significant effects were observed for any endpoint. In addition, gonadal histopathology was examined qualitatively. The qualitative assessment of gonadal tissues suggested the presence of increases in the incidence and severity of spermatogonia in testes of males in both treatment groups, increased incidence of oocyte atresia in females in both treatment groups, and altered gonadal stage scores in both males and females at the high concentration. These diagnoses were characterized by visual impression of relative changes in the numbers of various cell types. No statistics were carried out to identify if the differences observed were significant or not. They are therefore not relevant for REACH.

INVERTEBRATES

Two 96 hr acute toxicity studies of benzyl butyl phthalate on the saltwater shrimp Mysidopsis bahia are available. Both are acceptable for use as key studies for this endpoint.

EG&G Bionomics (1979) report a 96 hr LC50 of 0.9 ppm. This test followed the guideline "The Committee on Methods for Toxicity Tests with Aquatic Organisms 1975. Methods for acute toxicity tests with fish, macro-invertebrates, and amphibians. U.S. Environmental Protection Agency, Ecological Research Series, EPA-600/3-75-009. 61 p".

Suprenant (1988) report an unbounded 96 hr LC50: >0.74 mg/L (the highest test concentration resulted in less than 50% mortality). This test followed an EPA/OTS guideline.

A number of other studies are available which cover a variety of aquatic invertebrate species and are used as supprting studies. LC50 values of >0.96 - 9.63 mg/L are reported.

Two studies of the chronic toxicity of benzyl butyl phthalate to Daphnia magna are available. Both are useable as key studies for the fulfilment of this endpoint.

Rhodes et al. (1995) performed a 21 day flow-through test. The NOEC, based upon mortality and reproduction of the daphnids was 0.28 mg/L (the LOEC was 1.4 mg/L).

EG&G Bionomics (1979) performed a two-generation 42 day flow through test. The NOEC, based upon mortality and reproduction of the daphnids was 0.26 mg/L. Effects were seen at the 0.76 mg/L level.

Monsanto (study number 86 -7 -2074) report the 28 day NOEC of the substance to the shrimp Mysidopsis bahia is 0.075 mg/L. This relates to the reproduction of the mysids. This study has not been reviewed. However the study, and its result, are considered valid in the BBP EU RAR and therefore this result will be used in the environmental assessment as it is the most sensitive chronic result for invertebrates.

Data from review articles from Staples (1997) and Gledhill (1980) reviews can be used as supporting studies. These report NOECs for Daphnia magna of 0.35 and 0.26 mg/L respectively.

ALGAE

Four studies were reviewed for this endpoint and were considered key studies for this endpoint . These were GLP compliant studies following standard guidelines and are useable as key studies for the fulfilment of this endpoint. These four concern static, 72 h tests.

Huntingdon Life Sciences (2000a) reports an EC50 for Scenesmus subspicatus of 1.5 mg/L - this relates to growth rate. The NOEC was 0.15 mg/L. This test followed the OECD 201 and EU Method C3 guidelines.

Huntingdon Life Sciences (2000b) reports an EC50 for Naviculla pelliculosa of 0.66 mg/L - this relates to biomass which is the most sensitive endpoint. The NOEC was 0.17 mg/L. This test followed the OECD 201 and EU Method C3 guidelines.

Carolina Ecotox (1995a) reports an EC50 for Naviculla pelliculosa of 0.414 mg/L - this relates to area under the growth curve. This test followed the OECD 201 and EC Annex V - Supplement guidelines.

Carolina Ecotox (1995b) reports an EC50 for Scenedesmus subspicatus of 0.325 mg/L - this relates to area under the growth curve. This test followed the OECD 201 and EC Annex V - Supplement guidelines.

NOECs were not taken from the Carolina Ecotox studies as they related to cell counts.

Supporting studies from Monsanto (1985) and ABC Laboratories (1996) report EC50 values of 0.52 and 0.31 mg/L respectively.

OTHER

Two studies are available which have determined the toxicity of benzyl butyl phthlate to sediment organisms in freshwater aquatic (non-sediment) scenarios.

Call (2001) reports 10 -day LC50 values of 0.46, >1.76 and 1.23 mg/L of the susbtance toHyalella azteca, Chironomus tentans, and Lumbriculus vanegetus respectively.

Calvert (1982) reports 48 hr LC50 and NOEC values of the substance to Chironomus tentans of 1.64 and 1.25 mg/L respectively.