Registration Dossier
Registration Dossier
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EC number: 203-180-0 | CAS number: 104-15-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
The ASA Category comprises the following 5 aromatic sulphonic acids:
TSA, Toluene-4-sulphonic acid (EC 203-180-0, CAS 104-15-4)
XSA, (Xylenes and 4-ethylbenzene) sulphonic acid (EC 701-247-3, CAS -) Former EC 246-839-8
CSA, p-cumene sulphonic acid (EC 240-210-1, CAS 16066-35-6)
BSA, Benzene sulphonic acid (EC 202-638-7, CAS 98-11-3)
HBSA, 4-hydroxybenzensulphonic acid (EC No. 202-691-6, CAS No. 98-67-9)
The toxicity to reproduction and development was assessed with available test on ASA and related salt (Hydrotropes category). Hydrotropes are considered similar to ASA and could be use as read across.
BSA was tested under OECD 422 extended to 90 days toxicity and the NOAEL for reproduction and developmental toxicity was established as 500 mg of active ingredient /kg body weight/day which is the highest tested dose. This highest dose was selected based on the effects on the repeated dose part of the study. All changes in reproductive parameters observed in parental males and females at all dose levels were considered to be of no toxicological significance.
There are available studies for the chemically related hydrotrope substances that looked at reproductive organs. Hydrotropes are the salt form of the sulphonic acids and therefore are used as a support for this endpoint.
The study on STS performed under OECD 421 did not show any effects. The 90-day oral rat and oral mouse studies and the 2-year chronic dermal rat and mouse studies on SXS included examination of sex organs of both sexes. No treatment related effects on reproductive organs were reported at doses. A new OECD 443 was performed on SXS which is the most representative member of the hydrotropes category since it contains a significant proportion of both mono-alkyl (ethyl) and di-alkyl (dimethyl) chemical species and thus represents both the mono-alkyl and di-alkyl substances contained within the category.
The available results on reproductive toxicity are:
STS, OECD 421 (2004): NOAEL = 1000 mg a.i./kg bw
BSA, OECD 422 extended to 90 days (2020): NOAEL= 500 mg a.i./kg bw
SXS, OECD 443 (2021): NOAEL for SYSTEMIC TOXICITY = 1000 mg/kg/day for P and F1 male/female
NOAEL for REPRODUCTION and DEVELOPMENT = 1000 mg/kg/day
The NOAEL value used for the risk assessment for the reproduction toxicity is 500 mg/kg bw from the OECD 422 extended to 90 days toxicity performed on BSA.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The database consists of reliable GLP studies.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
The ASA Category comprises the following 5 aromatic sulphonic acids:
TSA, Toluene-4-sulphonic acid (EC 203-180-0, CAS 104-15-4)
XSA, (Xylenes and 4-ethylbenzene) sulphonic acid (EC 701-247-3, CAS -) Former EC 246-839-8
CSA, p-cumene sulphonic acid (EC 240-210-1, CAS 16066-35-6)
BSA, Benzene sulphonic acid (EC 202-638-7, CAS 98-11-3)
HBSA, 4-hydroxybenzensulphonic acid (EC No. 202-691-6, CAS No. 98-67-9)
The available results on developmental toxicity are:
BSA, OECD 422 extended to 90 days (2020): NOAEL= 500 mg a.i./kg bw
HBSA, OECD 414 (2020): NOAEL = 1000 mg a.i./kg bw
SCS, OECD 414 (2020): NOAEL = 1000 mg a.i./kg bw
CaXS, OECD 414 (1994): NOAEL = 936 mg a.i./kg bw
SXS, OECD 414 (rabbits): NOAEL = 1000 mg a.i./kg bw
SXS, OECD 443 (2021): NOAEL = XX mg a.i./kg/bw
In OECD 414 on HBSA, the NOAEL for maternal toxicity and prenatal development was established as 1000 mg of a.i./kg bw/day. This NOAEL is based on no mortality of females, no changes in health condition status, no alteration to thyroid hormone measurements, no pathological findings in the dams and no dose-related changes in reproduction parameters and based on no altered growth and no significant treatment-related structural abnormalities in foetuses of pregnant rats dosed up to 1000 mg of a.i./kg bw/day.
BSA was tested under OECD 422 extended to 90 days toxicity and the the NOAEL for developmental toxicity was established as 500 mg of active ingredient /kg body weight/day which is the highest tested dose. This highest dose was selected based on the effects on the repeated dose part of the study. All changes in development parameters of pups at all dose levels were considered to be of no toxicological significance.
There are available studies for the chemically related hydrotrope substances that looked at reproductive organs. Hydrotropes are the salt form of the sulphonic acids and therefore are used as a support for this endpoint.
The study with CaXS performed under similar condition of OECD 414 guideline showed no adverse effects. The NOAEL for both maternal and foetal toxicity was the highest dose tested and the conclusion of the study was no indications of developmental toxicity including teratogenesis. The study performed on SCS confirms the absence of effects on developmental toxicity.
The 90-day oral rat and oral mouse studies and the 2-year chronic dermal rat and mouse studies on SXS included examination of sex organs of both sexes. No treatment related effects on developmental toxicity were reported at doses. A new OECD 443 was performed on SXS which is the most representative member of the hydrotropes category since it contains a significant proportion of both mono-alkyl (ethyl) and di-alkyl (dimethyl) chemical species and thus represents both the mono-alkyl and di-alkyl substances contained within the category.
The NOAEL value used for the risk assessment for developmental toxicity is 500 mg/kg bw from the OECD 422 extended to 90 days toxicity performed on BSA.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The database consists of reliable GLP studies.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
From the available studies of both aromatic sulphonic acid and related salts, there is no concerns for reprodution and developmenatl toxicity.
No classification for STOT is warrented at present under Regulation 1272/2008.
Additional information
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