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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Read Across: OECD 422 (Harlan, 2013): NOAEL = 1000 mg/kg (systemic and local)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

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

Produkt SPS was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test. The study was conducted according to OECD 422 guideline and GLP (Harlan, 2013).

The following dose levels were applied:

Group 1: 0 mg/kg body weight/day (control group)

Group 2: 100 mg/kg body weight/day

Group 3: 300 mg/kg body weight/day

Group 4: 1000 mg/kg body weight/day

A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (Milli-Q-Water).

The following results were obtained:

Parent Animals:

General Tolerability

All animals survived until scheduled necropsy. No clinical signs were noted in males and females at any dose level.

Food Consumption and Body Weights

No adverse effects on mean food consumption and mean body weights of males and females were observed at any dose level.

Clinical Laboratory Investigations

No test item-related findings were noted during the clinical laboratory investigations.

Reproduction and Breeding Data

Mean precoital time, fertility index and conception rate were not affected by the treatment with the test item. No effects on implantation loss or postnatal loss were observed.

Organ Weights

No effects on organ weights were noted in any group.

Macroscopical Findings and Histopathological Examinations

There were no test item-related macroscopical or microscopical findings in any group.

Litter Data - F1 Pups

Findings at First Litter Check and during Lactation

The mean number of pups at first litter check was not affected by the treatment with the test item. The sex ratio was also not affected. No abnormal pup was noted at any dose level.

Pup Weights to Day 4 Post Partum

No effects on pup weight and pup weight gain were observed.

Macroscopical Findings

At necropsy of pups, there were no abnormal findings.

Conclusion

Based on these results the NOAEL (No Observed Adverse Effect Level) for general and reproductive toxicity was considered to be 1000 mg/kg body weight/day.

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 data, the test substance is not classified with regard to repeated dose toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.