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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No test with the target substance is available. The three source substances are classified as STOT RE 2, H373 (may cause damage to organs through prolonged or repeated exposure; target organs: gastro-intestinal tract, liver, immune system). The target substance is classified as STOT RE 2, H373 (gastro-intestinal tract, liver, immune system) according to the precautionary principle.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

Details on repeated dose studies for source substances (according to ECHA 2008, EU RISK ASSESSMENT - PRIMARY ALKYL AMINES):

 

Source substance 1

In a 28-day study on tallow alkylamines, which was compliant to the OECD 407 test guideline for the general toxicity, the predominant toxic effects were dilation and mucosal erosion of the gastrointestinal tract associated with emaciation, general poor health status and unscheduled deaths at 150 mg/kg bw/d. Besides, a dose-dependent slight to marked accumulation enteropathy was predominant in the distal parts of the small intestine of rats at all test doses. The accumulation of the test substance in histiocytes was obvious in the draining (mesenteric) lymph nodes, but also in the intestinal submucosa. Other treatment- elated adverse effects were liver toxicity, immunosuppression of lymphoid tissues, adrenal hyperplasia. Additional effects (mucosal hyperplasia in the intestine, leukocytosis) were associated with the primary damage of the gastrointestine. The LOAEL was 12.5 mg/kg bw/d.

 

Source substance 2

No repeated-dose toxicity study on animals that fully meets the testing standards is available.

 

Source substance 3

Repeated dermal application of the test item caused concentration-dependent mild to severe irritative to corrosive skin effects in rats. The lowest concentration tested (0.3%,≈12.5 mg/kg bw/d) in the dermal studies was the LOAELlocal for this route. Systemic toxicity was not adequately addressed in these studies. A guideline-compliant oral 28-day study in rats did not induce adverse effects at 3.25 mg/kg bw/d (NOAEL). Indications of toxicity at 50 mg/kg bw/d were growth depression at normal food consumption and increased enzyme activities indicative for minor liver or/and kidney dysfunctions. Motoric abnormalities (stilted gait), hemoconcentration and leucocytosis/ neutrophilemia observed at 50 mg/kg bw/d could not be related to other primary organ damage. Doses up to 50 mg/kg bw/d had no irritative properties on the mucosa of the gastrointestinal tract, while such effects associated with mortalities were seen at 400 mg/kg bw/d during week one of a preliminary study.

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on repeated dose toxicity, the test item is classified and labelled as may cause damage to organs through prolonged or repeated exposure (STOT RE2, H373) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.