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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Data from reliable sources (SIDS dossier of 4-aminotoluene-3-sulfonic acid and ECHA website for sulphanilic acid)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No data are available regarding effects on fertility for 5-methoxy-2-methylsulphanilic acid. 

We can assume the absence of concern regarding effects on fertility for 5-methoxy-2-methylsulphanilic acid based on read-across with two compounds of similar structure (more similar substance: 4-aminotoluene-3-sulfonic acid; less similar substance: sulphanilic acid).

For justification of read-across see attachment document in section 13.

In SIDS Dossier of 4-aminotoluene-3-sulfonic acid approved at SIAM 16 (27 -30 May 2003) with reference to Ministry of Health & Welfare, Japan (1999): Toxicity Testing Reports of Environmental Chemicals, vol.7 p163-171, "Preliminary Reproduction Toxicity Screening Test of 2-Amino-5-methylbenzenesulfonic acid by Oral Administration in Rats" no negative effects on fertility were observed after oral administration of the substance. 4-aminotoluene-3-sulfonic acid was administered to each 12 male and 12 female Sprague-Dawley (Crj: CD) rats at doses of 0, 100, 300, 1000 mg/kg/day by gavage. The dosing period for males was 48 days (before mating 14 days, during mating 14 days and after mating 20 days). The dosing period for pregnant females was 41 - 46 days (before mating 14 days, during mating 14 days maximum, during gestation about 21 days and after pregnancy 3 days). No compound-related dose effects were observed in the copulation index, fertility index, gestation length, number of corpora lutea or implanations, implanation index, gestation index, parturition or maternal behavior in any groups. From this study NOAEL for reproductive toxicity is considered to be 1000 mg/kg bw.

Also from information published on ECHA website with reference to an experimental study of 2010 regarding sulphanilic acid no adverse effects on fertility were observed. A daily oral administration of sulphanilic acid to Wistar rats at a dose level of 62,5 (50), 250 and 1000 mg/kg body mass over a time period of 41 to 79 days resulted in very few mild systemic and local effects in test animals treated with the high dose (1000 mg/kg) but did not produce any pathological evidence of local or systemic toxicity of the test item or any toxic effects on reproduction. From this study NOAEL for reproductive toxicity is considered to be 1000 mg/kg bw.

In conclusion, low concern regarding reproduction toxicity of 5-methoxy-2-methylsulphanilic acid should be assumed based on in vitro and in vivo studies for similar substances.

The public ECHA database contains data that are proprietary and cannot be used without the formal consent of the owner. In this summary, some of them have been used for precautionary purposes and for the benefit of the human health and the environment. Those data are not necessary for the registration of the target substance which is used exclusively as isolated and transported intermediate, but they can be very helpful for a better definition of the (eco) toxicological property of the substance. No other use and no commercial advantage will derive from the use of those data.


Short description of key information:
5-methoxy-2-methylsulphanilic acid should have no effects on fertility based on data available for similar substances.

Justification for selection of Effect on fertility via oral route:
Read across with similar substances.

Effects on developmental toxicity

Description of key information
5-methoxy-2-methylsulphanilic acid  should not show developmental toxicity based on data available for similar substances.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Data from reliable sources (SIDS dossier of 4-aminotoluene-3-sulfonic acid and ECHA website for sulphanilic acid)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No data are available regarding developmental toxicity for 5-methoxy-2-methylsulphanilic acid. 

We can assume the absence of concern regarding developmental toxicity for 5-methoxy-2-methylsulphanilic acid based on read-across with two compounds of similar structure (more similar substance: 4-aminotoluene-3-sulfonic acid; less similar substance: sulphanilic acid).

For justification of read-across see attachment document in section 13.

In SIDS Dossier of 4-aminotoluene-3-sulfonic acid approved at SIAM 16 (27 -30 May 2003) with reference to Ministry of Health & Welfare, Japan (1999): Toxicity Testing Reports of Environmental Chemicals, vol.7 p163-171, "Preliminary Reproduction Toxicity Screening Test of 2-Amino-5-methylbenzenesulfonic acid by Oral Administration in Rats" no developmental toxicity was observed after oral administration of the substance. 4-aminotoluene-3-sulfonic acid was administered to each 12 male and 12 female Sprague-Dawley (Crj: CD) rats at doses of 0, 100, 300, 1000 mg/kg/day by gavage. There were no significant differences in number of offspring or live offspring, sex ratio, the live birth index, the viability index or the body weight in any groups. No pups with malformations were found in any groups. No changes in clinical signs and necropsy findings were observed in offspring. From this study NOAEL for developmental toxicity is considered to be 1000 mg/kg bw.

Also from information published on ECHA website with reference to an experimental study regarding sulphanilic acid no developmental toxicity was observed. A daily oral administration of sulphanilic acid to Wistar rats at a dose level of 62,5 (50), 250 and 1000 mg/kg body mass over a time period of 41 to 79 days resulted in very few mild systemic and local effects in test animals treated with the high dose (1000 mg/kg) but did not produce any pathological evidence of local or systemic toxicity of the test item or any toxic effects on development. From this study NOAEL for developmental toxicity are considered to be 1000 mg/kg bw.

In conclusion, low concern regarding developmental toxicity of 5-methoxy-2-methylsulphanilic acid should be assumed based on in vitro and in vivo studies for similar substances.

Regarding reference to information on ECHA website, the data owner contained in this summary are reported only in view of a precautionary purpose, in order to draw up a proposal for a C&L consistent with the characteristics of the substance, for use and handling and its safety. They will not be disseminated. A different use can be made of them with consent of the owners. For further information and legal notices, refer to ECHA website.


Justification for selection of Effect on developmental toxicity: via oral route:
Read across with similar substances.

Justification for classification or non-classification

Additional information