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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.01 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.025 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.8 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.509 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.151 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.296 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

P-TERT-AMYLPHENOL OESTROGENIC EFFECTS SUMMARY

It has been shown that p-tert-amylphenol can exhibit oestrogenic effects on aquatic organisms. The Environmental Risk Evaluation Report: 4-tert-pentylphenol (CAS No. 80-46-6) (Environment Agency, 2008) (EA Risk Report) found that reliable data indicate oestrogenic effects of p-tert-amylphenol can occur around 0.032 -0.224 mg/L. The following discussion is a summary of the studies presented in the EA Risk Report for p-tert-amylphenol. Such studies are also included in this dossier. In addition, a brief summary of relevant information from the OECD Report of the Validation of the 21-day Fish Screening Assay for the Detection of Endocrine Active Substances (September 2006) (OECD Study) is provided. A summary of the results of oestrogenic effects studies is provided below. In vitro studies and studies involving injection-type exposures were not considered environmentally relevant (based on exposure route) and not discussed here.

Medaka (Oryzias latipes)

Seki et al. (2003) conducted a two generation test starting with fertilized eggs in a flow-through system at 24°C. Results indicate a NOEC, based on F0 generation abnormal sex differentiation at 0.1 mg/L and NOEC, based on F0 vitellogenin induction, at <0.051 mg/L. F0 reproductive impairment, F1 length and F1 sex ration NOECs were all at 0.1 mg/L. Hagino et al. (2001) determined 28-day sex-reversal NOECs for male secondary sexual characteristics to be 0.01mg/L for dorsal fin length and anal fin length and 0.001 mg/L for papillary processes on anal fin and differentiation of male testes into ovaries. However, the EA Risk Assessment (2008) states that results from this study may be suspect as the study authors did not provide statistical support for their endpoint determinations. Fish, eggs to 60-days post-hatch were exposed to the test substance in a study by Yokota et al (2005) where the morphological sex-reversal was observed in XY fish. Complete inhibition of P45011bmRNA expression in gonads of sex-reversed XY fish at 60 days post-hatch was seen at >0.238 mg/L.

Common Carp (Cyprinus carpio)

Gimeno et al conducted several studies with common carp (1996, 1997, 1998a, 1998b). Gimeno et al. (1996) determined the NOEC for percentage oviduct and number of primordial germ cells to be 0.1 and 0.32 mg/L, respectively, in a test with 50-day-old fish in an intermittent flow-through system. In another study, Gimeno et al. (1997) determined, in a single concentration semi-static test with fertilized eggs, yolk sac larvae or fingerlings of a genetically male population, that the formation of oviducts in male fish and reduced number of primordial germ cells in gonads was at <0.07 mg/L. Gimeno et al. (1998a) conducted a study with male fish only, 50 days post-hatch, in an intermittent flow-through system. The NOEC for reproductive tract development (development of an oviduct) and primordial germ cell was <0.036 mg/L for both endpoints.  The NOEC, based on vitellogenin induction, was 0.09 mg/L. In a study with 210 days post-hatch fish, Gimeno et al. (1998b) determined the 90 day NOEC based on vitellogenin induction was 0.32 mg/L while the 90 NOECs for weight and viscerosomatic index, gonadosomatic index, spermatocrit, and testes histometry were >1.0, <0.032, 0.32, <0.032 mg/L, respectively. Smeets et al. (1999) exposed cultured hepatocytes in a semi-static system and determined the 96 hr vitellogenin induction NOEC to be 3.285 mg/L.

Fathead Minnow (Pimephales promelas):

Panter et al. (2006) found that plasma vitellogenin (VTG) induction NOEC occurred at 0.56 mg/L in an early life stage experiment. Other endpoints were measured such as the gonadosomatic index NOEC and gonadal sex of fish NOEC which were both 0.18 mg/L. Additionally, gonadal attachments NOEC was determined 0.056 mg/L while the liver and kidney histology NOEC was 0.56 mg/L. Panter et al. (2002) found the 21-day vitellogenin induction NOEC to be <0.01 mg/L in a flow-through test with 45-100 days post-hatch fish. However, the EA Risk Assessment (2008) notes that measured concentrations were greater than 56% of nominal.

Rainbow Trout (Oncorhynchus mykiss):

Hornung et al., (2003) conducted an experiment with hepatoma cells (RTH-149) in a static test system at two test temperatures. The EC50 for induction of reporter genes was 7.5X10-7M at 11°C and 6.9x10-7M at 18°C.

OECD Study

The OECD conducted a method validation study on three test substances using three fish species (medaka, fathead minnow, and zebrafish) to determine the inter-laboratory variability of the 21-day fish assay method for determined EDC effects. Effects such as VTG induction and gonadal histopathology were assessed in addition to mortality and spawning status for exposures at three concentrations (100, 320 and 1,000 ug/L). For medaka, No variation in spawning was observed between the control groups and treated groups and the positive control at all test concentrations. For the fathead minnow, spawning was reduced in a concentration-dependent manner for tests at all three labs. No clear spawning effects were seen for the zebrafish in any test concentration. Gonadal histopathological results were not consistent across laboratories and no specific endpoint conclusions were made on the gonadal effects of p-tert-amylphenol from this study. However, it was determined that gonadal histopathology was as sensitive as VTG induction as an indication of EDC effects as effects were seen at the lowest test concentration of 100 ug/L for fathead minnow and zebrafish. Exposure to p-tert-amlyphenol caused VTG induction in males of the three fish species within the range of concentrations tested. Significant VTG induction was observed at 100 μg/L in medaka and at 320 ug/L in fathead minnow and zebrafish.

Conclusion:

The EA Risk Assessment (2008) found that reliable data indicate oestrogenic effects of p-tert-amylphenol can occur around 0.032-0.224 mg/L. Although some available individual test data (Hagino et al. 2001, Panter et al., 2002) presents effects seen at lower concentrations, reliability of these studies is questionable. There are no other reliable data available that confirm such results.

The calculated PNECfreshwater and PNECmarine as presented in this CSR Report are 0.01 mg/L and 0.01 mg/L and therefore, likely protective of oestrogenic effects exerted by p-tert-amylphenol. 

Conclusion on classification

p-tert-amylphenol does not fulfil the screening criteria for persistence (P-criterion), bioaccumulation (B-criterion), or toxicity (T-criterion). The overall conclusion is that p-tert-amylphenol

does not meet the PBT or vPvB criteria. No further testing or an emission characterisation and risk characterization for PBT/vPvB substances in accordance with REACH Article 14(4) is required.