Reaction mass of 1,2-Benzenedicarboxylic acid, 3-sulfo-, ammonium salt (1:3), 4-Sulphophthalic acid, ammonium salt, Ammonium sulphate

Endpoint summary

Description of key information

LD50 (oral, rat) > 2000 mg/kg bw (Bioassay, 2012)
LD50 (dermal, rat) > 2000 mg/kg (Bioassay, 2012; Read Across)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute Oral toxicity:

In an acute oral toxicity study performed according to OECD guideline 423 and GLP, 2000 mg/kg bw of the test item Decaltal N (preparation in deionized water) were administered to two test groups of three fasted Wistar rats by gavage. The following test substance-related clinical observations were recorded:

First test group: 2000 mg/kg

No clinical signs were observed, no mortality occured

Second Test group: 2000 mg/kg

- Mortality in one out of three animals

- Poor general state in one out of three animals

- Dyspnoea in one out of three animals

- Piloerection in one out of three animals

- Lateral position in one out of three animal

Macroscopic pathological findings in the animal that died:

o Dark red discoloration of the liver

o Red discoloration of the glandular stomach

o Liquid content in the glandular stomach

o Red discoloration of the small intestine

o Liquid content in the small intestine

o Congestion in the kidneys

The mean body weight of the surviving animals increased within the normal range throughout the study period, with the exception of one female of the first test group which showed stagnation of body weight during the second post-exposure week. There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period. The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Acute dermal toxicity

There is no data available for Decaltal N, however data from Produkt SPS can be used to assess this endpoint:

In a GLP compliant study, according to OECD guideline 402, the acute dermal toxicity of Produkt SPS following a single dermal application in male and female Wistar rats was investigated (Bioassay, 2012). A group animals (5/sex) was dermally exposed to Produkt SPS in 0.5% solution of CMC in deionized water at a dose level of 2000 mg/kg bw for 24 hours under semi-occlusive dressing and observed for 14 days. All animals survived until the end of the study period. There were no signs of systemic toxicity and no signs of skin effects. The mean body weight of the animals increased within the normal range throughout the study period, with the exception of two females which showed stagnation of body weight during the first post-exposure week, but gained weight in a normal range during the second week. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute dermal LD₅₀of Produkt SPS after single dermal application in male and female rats is > 2000 mg/kg bw.

Read-across justification for Decaltal N and Produkt SPS

General information
Common Name	Decaltal N		Produkt SPS
Chemical Name	Reaction mass of 1,2-Benzenedicarboxylic acid, 3-sulfo-, ammonium salt (1:3), 4-Sulphophthalic acid, ammonium salt, Ammonium sulphate		Reaction mass of 1,2-Benzenedicarboxylic acid, 4-sulfo-, trisodium salt, 1,2- Benzenedicarboxylic acid, 3-sulfo-, sodium salt (1:3), Sodium sulphate
Composition [g/100g]	Tri-ammonium 4-sulfonatophthalate Tri-ammonium 3-sulfonatophthalate Di-ammonium-phthalate AmmoniumSulfate Water	15.5 4.5 0.7 78.4 0.47	Tri-sodium 4- sulfonatophthalate Tri-sodium 3-sulfonatophthalate Di-sodium-phthalate Sodium Sulfate Water	25.5 7.6 1 60.6 4.8

 

Product SPS and Decaltal N are grouped into a category based on the similar composition of these two reaction masses. Both products consist of salts of sulfophthalic acid and – mainly – of sodium sulphate (Product SPS) or ammonium sulphate (Decaltal N), respectively. The exact compositions of both products were determined by 1H-NMR spectroscopy and are listed in the table above.

Considering that sodiumsulfate as well as ammonium sulfate are not classified for any toxicological-relevant endpoint according to Directive 67/548/EC and 1272/2008/EC (CLP), it can be concluded that their toxicological hazardfor human health is insignificant. As a consequence, the toxicity of Product SPS and Decaltal N is supposed to be mainly driven by the salts of sulfophthalic acid as both ammonium and sodium ions are naturally occurring in the human body and their concentrations are tightly regulated, they do not pose a health hazard per se.The content of the salts of sulfophthalic acid is higher in Produkt SPS as compared to Decaltal N (approximately 33% versus 24%). Hence, using the toxicological results of Produkt SPS for the assessment of the toxicity of Decaltal N displays a worst-case scenario and therefore a reasonable and justified approach.

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity study, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP).