N-(2-hydroxyethyl)dodecanamide

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

low hazard (no threshold derived)

Additional information - workers

NOAEL (systemic toxicity) = >= 1000 mg/kg bw/day (no hazard identified); OECD 422 (Anon., 2018)

In a study conducted in accordance with OECD 422, three groups of 10 male and 10 female rats received N-(2-hydroxyethyl) dodecanamide at the doses of 100, 350 and 1000 mg/kg/day. No test-item-related mortality was observed during the study, and administration of N-(2-hydroxyethyl) dodecanamide at 100, 350 or 1000 mg/kg/day was considered not to have any relevant effects on clinical condition, body weight, food consumption, grip strength, sensory reactivity and motor activity, pre-coital interval, mating performance and fertility, or gestation length. Salivation was recorded in all test-item-administered groups; the incidence was dose-related in both sexes and is most likely due to taste aversion (from gavage dosing). Estrous cycles before and during treatment were considered not to be altered by the test item. At termination, all reproductive phase females showed diestrus. In males administered at 1000 mg/kg/day, hematocrit, hemoglobin and lymphocytes were affected with respect to Control. Although it cannot be considered an adverse effect as the males’ physiology was not affected, and it was not possible to positively attribute the finding to the test item. There were no differences in coagulation, clinical biochemistry or organ weights considered treatment-related. T4 analyses of samples in F0 males and F1 offspring on day 13 did not reveal any differences that could be attributable to treatment. There were no macroscopic findings that could be considered test-item-related. Histopathology revealed that there were no treatment-related effects in any of the examined organs or in the reproductive organs or mammary glands. There were no adverse effects observed in the offspring. So, offspring survival, litter size, clinical signs, body weights, ano-genital distances or macropathology were not affected by N-(2-hydroxyethyl) dodecanamide administration.

The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be >= 1000 mg/kg/day for males and the NOEL was >= 1000 mg/kg bw/day for females.

The hazard conclusion for reproductive and developmental toxicology were as follows (OECD 422, Anon., 2018):

NOAEL(fertility) = >= 1000 mg/kg bw/day (no hazard identified)

NOAEL(development) = >= 1000 mg/kg bw/day (no hazard identified)

The results are based on the observations of no effects on estrous cycle, pre-coital interval, mating performance, fertility and gestation length or in the offspring on litter size, survival, sex ratio, clinical signs, body weights, ano-genital distances or macropathology.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Explanation for the modification of the dose descriptor starting point:

In accordance with Annex VIII, Section 8.5.2, Column 2 of REACH, testing by the inhalation route was waived due to low vapour pressure and a use pattern resulting in exposure to humans being considered negligible.  No acute toxicity hazard (leading to classification & labelling) has been identified for the substance following oral and dermal exposure.  No acute inhalation hazard is therefore identified for this substance.

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

low hazard (no threshold derived)

Additional information - General Population

NOAEL (systemic toxicity) = >= 1000 mg/kg bw/day (no hazard identified); OECD 422 (Anon., 2018)

In a study conducted in accordance with OECD 422, three groups of 10 male and 10 female rats received N-(2-hydroxyethyl) dodecanamide at the doses of 100, 350 and 1000 mg/kg/day. No test-item-related mortality was observed during the study, and administration of N-(2-hydroxyethyl) dodecanamide at 100, 350 or 1000 mg/kg/day was considered not to have any relevant effects on clinical condition, body weight, food consumption, grip strength, sensory reactivity and motor activity, pre-coital interval, mating performance and fertility, or gestation length. Salivation was recorded in all test-item-administered groups; the incidence was dose-related in both sexes and is most likely due to taste aversion (from gavage dosing). Estrous cycles before and during treatment were considered not to be altered by the test item. At termination, all reproductive phase females showed diestrus. In males administered at 1000 mg/kg/day, hematocrit, hemoglobin and lymphocytes were affected with respect to Control. Although it cannot be considered an adverse effect as the males’ physiology was not affected, and it was not possible to positively attribute the finding to the test item. There were no differences in coagulation, clinical biochemistry or organ weights considered treatment-related. T4 analyses of samples in F0 males and F1 offspring on day 13 did not reveal any differences that could be attributable to treatment. There were no macroscopic findings that could be considered test-item-related. Histopathology revealed that there were no treatment-related effects in any of the examined organs or in the reproductive organs or mammary glands. There were no adverse effects observed in the offspring. So, offspring survival, litter size, clinical signs, body weights, ano-genital distances or macropathology were not affected by N‑(2-hydroxyethyl) dodecanamide administration.

The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be >= 1000 mg/kg/day for males and the NOEL was >= 1000 mg/kg bw/day for females.

The hazard conclusion for reproductive and developmental toxicology were as follows (OECD 422, Anon., 2018):

NOAEL(fertility) = >= 1000 mg/kg bw/day (no hazard identified)

NOAEL(development) = >= 1000 mg/kg bw/day (no hazard identified)

The results are based on the observations of no effects on estrous cycle, pre-coital interval, mating performance, fertility and gestation length or in the offspring on litter size, survival, sex ratio, clinical signs, body weights, ano-genital distances or macropathology.