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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.78 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

  • Repeated dose toxicity:

    The dose descriptor starting point was the NOAEL of 50.6 mg/kg bw from a 90d feeding study. The corrected starting point (inhalatory NOAEC) was 44.6 mg/m3. Applying an overall assessment factor of 25 results in a DNEL of 1.78 mg/m3 for an 8h working day.

 

  • Sensitisation (skin):

    Step 1, qualitative approach:
    According to Chapter R.8, Table R.8-23 and based on the results of a LLNA skin sensitising potency of 4-Methylsulfonyl-2-nitrobenzoic acid is categorised as “strong”, because EC3(%) is > 0.2 and < 2.0. According to section E.3.4 for extreme and strong sensitizers RMMs, OCs, and PPE have to be considered as listed under “High Hazard” in Table E.3-1.

    Step 2, DNEL setting:
    For the judgement of the remaining risks after RMMs and OCs implementation a DNEL was derived as follows:

    The highest 4-Methylsulfonyl-2-nitrobenzoic acid concentration tested, that didn’t induce a SI above 3, was found to be 1%. Conversion into µg/cm2results in a value of:

    1% x 250 µg/cm2/ % = 250 µg/cm2

    that can be considered as the NOAEL for induction.

 

  • Effect on fertility

    The composition of 4-Methylsulfonyl-2-nitrobenzoic acid is as follows:
    80% 4-Methylsulfonyl-2-nitrobenzoic acid, 17% water, 2%NMST (1-methyl-4-(methylsulfonyl)-2-nitrobenzene, CAS#1671-49-4). NMST is classified as Repr. Cat. 3; R62 - Xn; R22 - R43 - R52-53 (1st ATP to Regulation (EC) No 1272/2008). Based on a study according to OECD 415 the NOAEL for the reproductive toxicity (male fertility) of NMST has been set at 15 mg/kg bw.. This value is equivalent to a 4-Methylsulfonyl-2-nitrobenzoic acid dose of 750 mg/kg bw.. Since this value is clearly above the NOAEL of 50.6 mg/kg bw for 90d repeated dose toxicity of 4-Methylsulfonyl-2-nitrobenzoic acid, derivation of an additional DNEL for reproductive toxicity is dispensable (even then, when considering an additional assessmenet factor of 3 for the dose response curve motivated by the severity of fertility effects seen at LOAEL (100 mg/kg bw) in the reproductive toxicity study).

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

4-Methylsulfonyl-2-nitrobenzoic acid is an intermediate handled under SCC. Therefore an exposure of the general population is excluded. Consequently there is no need for DNEL derivation for the general population.