2-naphthol

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

other: Assessment of the relevance of long-term toxicity testing on invertebrates

Adequacy of study:

weight of evidence

Study period:

May 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Assessment of the relevance of long-term toxicity testing on invertebrates

Data source

Reference

Reference Type:

other: Expert assessment

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Assessment of the relevance of long-term toxicity testing on invertebrates

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-naphthol

EC Number:

205-182-7

EC Name:

2-naphthol

Cas Number:

135-19-3

Molecular formula:

C10H8O

IUPAC Name:

2-naphthol

impurity 1

Reference substance name:

1-naphthol

EC Number:

201-969-4

EC Name:

1-naphthol

Cas Number:

90-15-3

Molecular formula:

C10H8O

IUPAC Name:

1-naphthol

Test material form:

solid: flakes

Results and discussion

Effect concentrations

Key result

Remarks on result:

other: Assessment of the relevance of long-term toxicity testing on invertebrates

Applicant's summary and conclusion

Validity criteria fulfilled:

not applicable

Conclusions:

2-Naphthol is imported into the EU and then directly exported. As such, the substance has no uses within the EU at the Annex IX tonnage band and the risk of exposure to the aquatic environment is minimal. Therefore, it is reasonable to conclude that no long-term toxicity studies on aquatic invertebrates are required.

Executive summary:

The substance, 2-naphthol, is imported into the EU within the 100-1000 t/a band and therefore the registration dossier must satisfy the requirements stated in Annex IX.  A data-gap analysis has indicated that there is a lack of available information regarding the long-term toxicity testing on to aquatic invertebrates meaning that these studies should be considered to support the Annex IX registration taking into consideration the findings of the chemical safety assessment. 

 

According to Annex XI, general rules for adaptation of the standard testing regime set out in Annexes VII-X, testing can be tailored according to exposure.  Annex XI states that ‘testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted based on the exposure scenario(s) developed in the Chemical Safety Report’.

 

2-Naphthol is directly exported from the EU after import and, as such, has no uses within the EU at the Annex IX tonnage band, and as such no exposure scenarios have been developed.  As there are no exposure scenarios, it can be reasonably assumed that the likelihood of workers, the general public or the environment being exposed to the substance under normal or reasonably foreseeable conditions of use is negligible.

 

 

 

2-naphthol is imported into the EU and transported to a storage warehouse until the substance is ready to be exported from the EU.  During storage, the substance containers are never opened and remain secure until they are ready to be exported from the EU.  As there is no exposure to the environment during storage and the risk of exposure during transit is minimal, it is reasonable to conclude that no long-term toxicity testing on aquatic invertebrates is required.