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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.052 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
other: NOEL
Value:
401.303 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
for duration
AF for interspecies differences (allometric scaling):
1
Justification:
for species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for worker
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
48.15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.146 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
other: NOEL
Value:
114.64 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
for duration
AF for interspecies differences (allometric scaling):
4
Justification:
for species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for worker
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.438 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Toxicokinetics

The Annex VIII of the REACH regulation requires an assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information. There is no available data on the toxicokinetics of the chemical 2-hydroxynaphthalene-1-carbaldehyde [Synonym: C.I. Pigment Yellow 101]. Toxicokinetics is essentially the study of "how a substance gets into the body and what happens to it in the body". Four processes are involved in toxicokinetics; namely absorption, distribution, metabolism and excretion (ADME). It may be noted that the chemical 2-hydroxynaphthalene-1-carbaldehyde [Synonym: C.I. Pigment Yellow 101] is a fluorescent color having applications such as use in manufacturing of Daylight Fluorescent Resin Pigments, textile dyeing, ink application, plastic colouration, Leak / Crack Detection & Non-Destructive Testing (NDT). Since the chemical is not a food dye, it is unlikely to be ingested and there is a low possibility of the chemical exerting a toxic effect after ingestion. The chemical is expected to have low potential for absorption across biological membranes due to the very low solubility in water and corresponding high estimated partition coefficient value. The particle size distribution of the chemical was found to be in the range of 150 micron to 25 micron. Thus, the likelihood of inhalation of these particles is low. Considering all of the above, this end point was considered for waiver. Also the bio-accumulation potential of the chemical is considered to be low.

Acute toxicity:

Based upon the study results and available information, the substance is not expected to show acute toxicity effect by the inhalation, oral and dermal route and thus will not be considered for further classification.

Skin & eye irritation:

The available studies indicate that substance is found to be non irritating to skin and eye and hence is classified as a 'non-irritant' to skin and eye according to CLP regulation

Skin sensitisation:

Experimental resulted conducted using OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) did not indicate any sensitization effect in the female mice on which test was conducted. Thus, the chemical is classified as "Not Sensitizing".

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.911 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
other: NOEL
Value:
95.564 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
duration
AF for interspecies differences (allometric scaling):
1
Justification:
species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
General population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.733 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.136 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
other: NOEL
Value:
27.3 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
duration
AF for interspecies differences (allometric scaling):
4
Justification:
species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.408 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.528 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
other: NOEL
Value:
305.709 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
duration
AF for interspecies differences (allometric scaling):
4
Justification:
species
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.584 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL derivation

2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene] hydrazone neither exhibit acute toxicity by dermal and inhalation route of exposure, nor the toxicity is observed via oral route. The chemical was not found to be irritating to skin and eye. Available data indicates that the chemical does not exhibit genotoxicity and is not a reproductive and developmental toxin within the dose levels mentioned in the end points.  

 

In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.

 

In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.

 

A standard approach to deriving DNEL values in this case would be to use the repeated toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the oral 305.709 mg/kg.