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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
176.3 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):
10
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
No study on long-term inhalation toxicity available.

The original study is reliable without restrictions.

The original study is reliable without restrictions.

The route to route extrapolation was performed by applying the equation as cited in Guidance on information requirements and chemical safety assessment, Chapter R.8 (by ECHA) with all recommended assessment factors.

AF for dose response relationship:
1
Justification:
Default value for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic exposure- according to Guidance on information Chapter R.8, Table 8-5, p. 29
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not necessary for the inhalation route
AF for other interspecies differences:
1
Justification:
No default additional interspecies factor is used, since additional interspecies variability is accounted for in the default assessment factor for intraspecies variability (ECETOC Technical Report 86, 2003).
AF for intraspecies differences:
5
Justification:
Default value for workers- according to Guidance on information Chapter R.8, Table 8-6, p. 32
AF for the quality of the whole database:
1
Justification:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
29.41 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 176.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Long-term dermal systemic DNEL based on NOAEL (90d, rat , oral, OECD 408)

Long-term dermal systemic DNELbased on NOAEL (90 d, oral) in rats:
a. NOAEL(dermal) derived according to “Guidance on information requirements and chemical safety assessment”, Chapter R8-2, Example B.5 (p. 69).
corrected NOAEL(dermal)         = NOAEL(oral, rat) x Absorption(oral-rat)/Absorption(dermal-human)
                                                  = 1000 mg/kg bw/d x 100%/85%
                                                  = 1176,5 mg/kg bw/d

(ca. 85% dermal absorption in human based on a dermal absorption study of Methylparaben)

b. DNEL(dermal) derived from corrected NOAEL(dermal) applying the assessment factor 40 (4(interspecies rat-human) x 5(intraspecies worker) x 2(subchronic-chronic))

=> =29,41 mg/kg bw/d

AF for dose response relationship:
1
Justification:
Default value for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human
AF for other interspecies differences:
1
Justification:
No default additional interspecies factor is used, since additional interspecies variability is accounted for in the default assessment factor for intraspecies variability (ECETOC Technical Report 86, 2003).
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
AF for remaining uncertainties:
1
Justification:
No further AF applied, since no effects were observed at NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.45 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):
20
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
869.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
No study on long-term inhalation toxicity available.
AF for dose response relationship:
1
Justification:
Default value for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
2
Justification:
suchronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not necessary for the inhalation route
AF for other interspecies differences:
1
Justification:
No default additional interspecies factor is used, since additional interspecies variability is accounted for in the default assessment factor for intraspecies variability (ECETOC Technical Report 86, 2003).
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
14.7 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 176.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No study on long-term dermal toxicity available.
AF for dose response relationship:
1
Justification:
Default value for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human
AF for other interspecies differences:
1
Justification:
No default additional interspecies factor is used, since additional interspecies variability is accounted for in the default assessment factor for intraspecies variability (ECETOC Technical Report 86, 2003).
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
AF for remaining uncertainties:
1
Justification:
No further AF applied, since no severe effects were observed at NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.5 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification of dose descriptor starting point needed since original study used oral route.

AF for dose response relationship:
1
Justification:
Default value for NOAEL as starting point for DNEL calculation
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling rat to human
AF for other interspecies differences:
1
Justification:
No default additional interspecies factor is used, since additional interspecies variability is accounted for in the default assessment factor for intraspecies variability (ECETOC Technical Report 86, 2003).
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

There are no data available on long-term systemic toxicity of Sodium methyl 4-hydroxybenzoate. However, there are reliable data for Methylparaben which is considered to be suitable for read-across using the analogue approach. For details refer to read-across justification.

 

The general population is not exposed to neat Sodium methyl 4 -hydroxybenzoate, based on its identified uses. However, the long-term consumer DNELs for oral, dermal and inhalation systemic effects have been derived. No DNELs have been derived for the short-term dermal, inhalation and oral exposure of Sodium Methylparaben for the general population, as it is assumed that the assessment of hazard is sufficiently covered by deriving the respective DNELs for long-term exposure.

There are no quantitative dose-response data available for local short- and long-term effects on skin and respiratory tract of Sodium methyl 4 -hydroxybenzoate. The most sensitive local effects observed are skin irritation and eye corrosion.