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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test item was not tested for repeated dose toxicity.

It is acceptable to derive the systemic toxicity from experimental data of a structural analogue (di-sodium salt) since both are salts with comparable structures. In addition, lower solubility and the higher molecular weight of the test item give a safety margin.
A subacute toxicity study on rats (OECD 407, GLP) was performed to evaluate the repeated dose toxicity of the substance. The test item did not induce any mortalities, abnormalities or clinical symptoms. Based on the results of these studies, the NOEL and the NOAEL of the test substance is 1462.9 and 1552.1 mg/kg bw /d for male and female rats, respectively.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See read-across justification
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOAEL
Effect level:
15 000 ppm
Based on:
other: read-across
Sex:
male/female
Basis for effect level:
other: No adverse effects assumed
Dose descriptor:
NOAEL
Effect level:
1 462.9 mg/kg bw/day (nominal)
Based on:
other: read-across
Sex:
male
Basis for effect level:
other: no adverse effects assumed
Dose descriptor:
NOAEL
Effect level:
1 552.1 mg/kg bw/day (nominal)
Based on:
other: read-across
Sex:
female
Basis for effect level:
other: no adverse effects assumed
Critical effects observed:
no
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 462.9 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Read across justification

The test item was not tested for repeated dose toxicity. It is acceptable to derive the systemic toxicity from experimental data of a structural analogue (di-sodium salt) since both are salts with comparable structures. In addition, lower solubility and the higher molecular weight of the test item give a safety margin (a detailed read across justification is given in CSR, Annex I).

Procedure and observations

A structural analogue (di-sodium salt) was administered to male and female Wistar rats at dietary concentrations of 0, 1,500, 5,000 and 15,000 ppm (BASF AG 2002a). Control and high dose group consisted of each 10 animals per sex whereas low and mid dose group consisted of each 5 animals per sex. After 4 weeks of treatment 5 animals per sex of all dose groups were sacrificed (main groups). The remaining 5 animals per sex of control and high dose group were maintained for another 14-days without administration of the test substance. All animals were examined for clinical signs, body weight changes and food consumption, effects on biochemical parameters and hematology. Urinalysis as well as a functional observation battery were also performed.

No substance related effects were observed after treatment and after recovery period. The test substance did not cause mortalities or sings of toxicity and gross necropsy as well as histopathology was without findings. The only substance related effect was a yellow discoloration of the faeces.

Discussion

The test substance did not induce any mortalities, abnormalities or clinical symptoms. The only remarkable finding in the pre-study was a yellow discoloration of faeces. This incidental finding was considered to be due to the presence of the test substance in the faeces and not a manifestation oif toxicity. Thus, the no-observed-adverse-effect level (NOAEL) under the conditions of the present study was 15,000 ppm for both sexes or 1462.9 mg/kg bw for male and 1552.1 mg/kg bw for female rats, respectively.

Justification for classification or non-classification

 Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Commission Regulation (EU) 2018/1480 of Oct 4, 2018.