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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Ecotoxicological information

Toxicity to terrestrial arthropods

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to non-target arthropods on natural substrate (NTA other than pollinators)
Remarks:
Folsomia candida, natural soil
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer also to Read-Across Statement attached in Section 13

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In this read-across approach data on Naphthalene (CAS 91-20-3, EC 202-049-5) is used to fill data gaps for N-1-naphthylaniline (CAS 90-30-2, EC 201-983-0), in accordance with Regulation No 1907/2006 (REACH), Annex XI. The basis for this read-across approach is the “Read-Across Assessment Framework” (RAAF) (ECHA 2017). The read-across hypothesis for the analogue approach is that N-1-naphthylaniline and Naphthalene exhibit a comparable ecotoxicological hazardous potential as a consequence of structural similarity. The target substance N-1-naphthylamine is a member of Naphthalenes, with the Naphthalene structure being part of the molecule, representing a relevant structure in terms of their ecotoxicological effects. The differences in the molecular structure and the associated differences in physical properties explain the slight differences in the potency of the substance. Nonetheless, from a regulatory point of view, the degree of danger of both substances is comparable.
According to the RAAF this approach is covered by scenario 2, based on “different compounds with qualitatively similar properties”.
“This scenario covers the analogue approach for which the hypothesis is based on different compounds with the same type of effect(s). For the REACH information requirement under consideration, the effects obtained in a study conducted with one source substance are used to predict the effects that would be observed in a study with the target substance if it were to be conducted. The same type of effect(s) or absence of effect is predicted. The predicted strength of the effects may be similar or based on a worst-case approach.”

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Target chemical:
N-1-naphthylaniline, CAS number: 90-30-2, EC number: 201-983-0, Molecular formula: C16H13N, Molecular weight: 219.28 g/mol

Source chemical:
Naphthalene, CAS: 91-20-3, EC number: 202-049-5, Molecular formula: C10H8, Molecular weight: 128.17 g/mol

3. ANALOGUE APPROACH JUSTIFICATION
QSAR profiling reveal no significant differences between the source Naphthalene and the target substance N-1-naphthylaniline, the available data show a comparability of the relevant physico-chemical parameters and a similarity in the ecotoxicological profile, what justifies this read across. Thus, the available studies for the source substances Naphthalene are used to fill data gaps N-1-naphthylaniline for the following ecotoxicological endpoints: Toxicity to sediment organisms, Toxicity to soil microorganisms except arthropods, Toxicity to terrestrial arthropods, Toxicity to terrestrial plants and Toxicity to birds (for further details please refer to attached Read-Across Statement in Section 13).

4. DATA MATRIX
(please refer to attached Read-Across Statement in Section 13)
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
88 other: µmol/kg soil dw
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
28 d
Dose descriptor:
EC100
Effect conc.:
409 other: µmol/kg soil dw
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
reproduction

Analytical results:

Day 0: 80 to 105% recovery of naphthalene

Day 10: 7 to 20% recovery of naphthalene

Solvent control showed no effects of solvents.

Validity criteria fulfilled:
not specified

Description of key information

NOEC (28d) = 88 µmol/kg soil dw (measured initial, vehicle) for Folsomia candida (ISO 11267, read across)

Key value for chemical safety assessment

Additional information

No data are available for the toxicity of N-phenyl-1-naphthylamine to terrestrial organisms. Therefore, information from a supporting, structurally analogue compound (naphthalene) was taken into account.

In this key study, the toxicity of naphthalene (purity >99.0%) to the collembolan species Folsomia candida was tested following ISO guideline 11267 (Droge et al. 2006). Nominal concentrations of 62.5, 125, 250, 500 and 1000 mg/L were tested, with acetone as solvent. For initially 11- to 13-day old collembolans, the adult mortality and the number of produced juveniles were recorded after 28 days. The NOEC (28d) is determined to be 88 µmol/kg soil dw and the EC100 is determined to be 409 µmol/kg soil dw for mortality and reproductive output. A LC50 value could not be determined since two consecutive concentrations resulted in no effect and a complete effect.