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Description of key information

Based on results obtained with the read-across substance the oral median LD50 is considered to be greater than 5000 mg/kg bw in the rat.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The read-across is considered appropriate since the source and target substance consist of the same constituents at different proportions. The main constituent 1-(carboxymethyl)-dimethylpyridinium present at a concentration of ca. 22 % in the source substance caused no adverse effects in the respective toxicological endpoints. Thus, 1-(carboxymethyl)-dimethylpyridinium at 55 % as present in the target substance is not expected to cause adverse effects with regard to skin and eye irritation and acute oral toxicity.
Moreover, regarding acute oral toxicity a limit dose of 5000 mg/kg bw was tested with the source substance. This corresponds to 1100 mg 1-(carboxymethyl)-dimethylpyridinium / kg bw. This is equal to 2000 mg target substance/kg bw. Thus, the acute oral LD50 of the target substance can be considered to be at least > 2000 mg/kg bw. Other constituents, i. e. sodium acetate, sodium chloride and water, are not considered relevant in regards to local effects and or acute oral toxicity, since none of these require classification regarding these endpoints according to CLP.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
other: read-across source substance
Remarks on result:
other: no mortality observed with the source substance
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: target substance
Remarks on result:
other:
Remarks:
The read-across substance (consisting of 22 % 1-(carboxymethyl)-dimethylpyridinium) was tested at a dose level of 5000 mg/kg bw. This equals 1100 mg 1-(carboxymethyl)-dimethylpyridinium / kg bw. Which corresponds to 2000 mg target substance/kg bw. Thus, the acute oral LD50 of the target substance can be considered to be at least > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
GLP and guideline study of a read-across substance.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity of the test item is assessed by applying a read-across approach to CAS 85168 -84 -9. Read-across is considered suitable and reliable based on the following justification:

The read-across is considered appropriate since the source and target substance consist of the same constituents at different proportions. The main constituent 1-(carboxymethyl)-dimethylpyridinium present at a concentration of ca. 22 % in the source substance caused no adverse effects in the respective toxicological endpoints. Thus, 1-(carboxymethyl)methylpyridinium at 55 % as present in the target substance is not expected to cause adverse effects with regard to skin and eye irritation and acute oral toxicity.
Moreover, regarding acute oral toxicity a limit dose of 5000 mg/kg bw was tested with the source substance. This corresponds to 1100 mg 1-(carboxymethyl)-dimethylpyridinium / kg bw. This is equal to 2000 mg target substance/kg bw. Thus, the acute oral LD50 of the target substance can be considered to be at least > 2000 mg/kg bw. Other constituents, i. e. sodium acetate, sodium chloride and water, are not considered relevant in regards to local effects and or acute oral toxicity, since none of these require classification regarding these endpoints according to CLP.

Acute oral toxicity (CAS 85168 -84 -9)

The study was designed to assess the acute oral toxicity of the test material in the rat. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute 0ral Toxicity". The test system was chosen because the rat has been shown to be a suitable model for this type of study and is recommended in the test method. The results of the study are believed to be of value in predicting the likely toxicity of the test material to man. Five male and female Sprague-Dawly rats were orally administered the pure test item via gavage. Observations one and four hours after treatment revealed clinical signs of hunched posture and piloerection. These signs were reversible within one day. No mortality was observed within the 14 days observation period. No gross pathological findings were observed in the treated animals. Based on the results of this study, the LD50 of the test item is considered to be greater than 5000 mg/kg bw in the rat.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data on the read-across substance are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral toxicity with a read-across substance the test item does not require classification as acutely toxic according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.