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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
555.395 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):
40
Modified dose descriptor starting point:
NOAEC
DNEL value:
22 215.789 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
315 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):
40
Modified dose descriptor starting point:
NOAEL
DNEL value:
12 600 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - workers

Toxicokinetics:

In the absence of toxico-kinetic data for Eicosanoic acid, data from two read-across chemicals have been used.Docosanoic acid as well as Stearic acid have low dermal absorption; similar to  Eicosanoic acid. Also the vapour pressure of all the 3 chemicals is low. Thus exposure via the dermal and inhalation route is unlikely. Given that long chain fatty acids are poorly absorbed, they shall be bio-accesible in the living system at low levels. The predicted bio-concentration values for the 3 chemical are also very low.

Thus, based on the above, Eicosanoic acid is expected to have low bio-accumulation potential.

Acute toxicity effects:

Oral :-

The acute toxicity study was conducted to evaluate the toxic effects of administration of Eicosanoic acid to mouse by the oral route. The mouse were given the test substance by the oral route at a dose concentration of 5000 - 9800 mg/kg of Eicosanoic acid.The lethal dose (LD50) of Eicosanoic acid in mouse was found to be 8250 mg/kg of body weight.Toxic effects was not observed. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Eicosanoic acid does not exhibit acute toxicity via the oral route i.e it is acutely non toxic to animals within the dose level mentioned in the study.

Inhalation:-

This data was considered for waiver considering the low vapour pressure of this chemical (0.0000446 Pa ) as well as the particle size distribution. Majority of the particles were found to be in the size 1000 (65.03%) micrometer in size which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical Eicosanoic acid is highly unlikely.

Dermal:-

The acute toxicity study was conducted to evaluate the toxic effects of administration of Eicosanoic acid to New Zealand White rabbit by the dermal route. The lethal dose (LD50) of Eicosanoic acid in rabbit was found to be 3575.76 mg/kg of body weight.Toxic effects was not observed. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Eicosanoic acid does not exhibit acute toxicity via the dermal route i.e it is acutely non toxic to animals within the dose level mentioned in the study.

Skin irritation / corrosion

The primary irritation index (PII) on rabbit for Eicosanoic acid is estimated to be 1.62, based on this value it can be estimated that Eicosanoic acid is slightly irritating to rabbit skin. Morever the read across values also conclude that the substances will have irritation effect. Since these read across values have 90 - 100% structural similarity so the inference can be extrapolated to the target substance, Eicosanoic acid, as well.

Eye irritation

By the method of MMAS (The modified maximum average score) from QSAR,eye irritation score of Eicosanoic acid was estimated to be 33.4. On the basis of this score it infers that Eicosanoic acid showed slight irritation effect to the eyes of rabbit.(as the criteria MMAS >25 to < 59 is irritating

Skin sensitizer :

According to the quantitative structure activity relationship model prediction, Eicosanoic acid was predicted as a non -sensitizer to guinea pig skin by guinea pig maximisation test (GPMT). Also the same have been observed in the structural analog of the target chemical.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
136.957 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):
80
Modified dose descriptor starting point:
NOAEC
DNEL value:
10 956.522 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
157.5 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):
80
Modified dose descriptor starting point:
NOAEL
DNEL value:
12 600 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
78.75 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):
80
Modified dose descriptor starting point:
NOAEL
DNEL value:
6 300 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL derivation

Eicosanoic acid does not exhibits acute toxicity by any of the 3 route of exposure i.e. oral, inhalation and dermal route and thus will not be considered for acute toxicity classification. Eicosanoic acid was found to be irritating to skin and eye. Available data also indicates that the chemical does not exhibit genotoxicity; neither is it expected to be a reproductive toxin nor having developmental toxicity effect 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 would be to use the repeated dose toxicity/ reproductive toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 25200 mg/kg bw/d in repeated dose toxicity by the oral route.