Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

Endpoint summary

Additional information

The following results were obtained:

Fish

Acute

No mortality occurred in both studies, and no other effects were observed. It can be concluded that the substance does not cause mortality in fish at concentrations which are higher than its water solubility.

Chronic

Testing conducted in accordance with ECHA Decision number CCH-D-0000003873-68-05/F

According to the integrated testing strategy, the Daphnia study was to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.

As effects were noted within the Daphnia study, and refinement of the PNEC was required, this test was conducted subsequently in order to allow for accurate risk assessment.

The study assessed the possible lethal and sub-lethal effects of LOWINOX® CPL during the embryonic and early larval development of the fathead minnow. The results led to the following conclusions:

LOWINOX® CPL did not induce any statistically significant effects on embryonic survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for embryonic survival were 1.0 and >1.0 mg/l, respectively;

LOWINOX® CPL did not induce any statistically significant effects on larval survival at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval survival were 1.0 and >1.0 mg/l, respectively;

LOWINOX® CPL did not induce any statistically significant effects on larval growth at a concentration obtained in a WAF prepared at a loading rate of 1.0 mg/l. Hence, the NOELR and LOELR for larval growth were 1.0 and >1.0 mg/l, respectively.

Daphnia

Acute

No immobilisation occurred and no other effects were observed. It can be concluded that the substance does not cause any adverse effects to Daphnia magna at concentrations which are higher than its water solubility.

Chronic

Testing conducted in accordance with ECHA Decision number CCH-D-0000003873-68-05/F

According to the integrated testing strategy, the Daphnia study was to be conducted first. If based on the results of the long-term Daphnia study and the application of a relevant assessment factor, no risks are observed (PEC/PNEC<1), no long-term fish testing may need to be conducted. However, if a risk is indicated, the long-term fish study needs to be conducted.

Under the conditions of the present study LOWINOX® CPL appeared to statistically significantly reduced the number of offspring of Daphnia magna by 21% in a WAF prepared at a loading rate of 1.0 mg/l after 21 days of exposure. Hence, the NOELR for reproduction lies <1.0 mg/l. Other parameters are as follows:

NOELR for reproduction <1.0 mg/l

EL10 for reproduction <1.0 mg/l

EL50 for reproduction >1.0 mg/l

NOELR for mortality 1.0 mg/l

NOELR for growth 1.0 mg/l.

There is some doubt as to the definitive EC10 and NOELR values derived from the study demonstrating effects (the 21-day Daphnia study), as limit values of <1 mg/l where obtained for the reproduction endpoints. Given the deficiencies in the analytical method it is not clear as to whether these results are accurate. It was scientifically not possible to derive a lower value than this, due to the UVCB nature and low water solubility of the substance.

For the purposes of risk assessment and on the following grounds:

1) There are no effects at the limit of solubility in water in acute toxicity studies.

2) There are no effects in the chronic fish test at the limit of solubility in water.

3) Effects appear to be limited to reproduction only in the chronic daphnia  study, but there is some doubt regarding these results.

The value is set to 1 mg/l for the NOELR.

It is the intention of the registrant to repeat this study, as the effects noted are not as expected, and required further clarification. This test will be repeated to further clarify these results and a spontaneous update to the registration completed.

Algae

No adverse growth effects occurred and no other effects were observed. It can be concluded that the substance does not cause any adverse effects to algae growth at concentrations which are higher than its water solubility.

Sludge Micro-organisms

The bacteria did not show any effects on growth. It can be concluded that the substance does not cause growth effects in bacteria at concentrations which are higher than its water solubility.

Conclusion

The substance does not show adverse toxicity at acute levels in any of the trophic organisms studied, at its limit of solubility in water. It does not demonstrate chronic toxicity in fish also at the limit of solubility in water, using a water accommodated fraction method. The substance appears to cause minor effects in the reproduction of Daphnia at the limit of solubility in water, using a water accommodated fraction method, but demonstrates no effects on growth or mortality at the same levels. These results require further clarification, and the registrant intends to repeat this chronic daphnia test to refine these results.