Registration Dossier

Administrative data

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
Explanation for the modification of the dose descriptor starting point:

Due to no systemic toxicity and the fact that Taurine (with high water solubility and a log P value well below 0) may be too hydrophilic to cross the lipid rich environment of the stratum corneum it is highly improbable that an acute dermal toxicity study would result in any toxicity. In absence of further information concerning route specific effects through dermal exposure, no acute dermal DNELs are considered applicable. This is in line with ECHA's guidance document on information requirements and chemical safety assessment, part R8 that a DNEL for acute toxicity should only be derived if an acute toxicity hazard (leading to C&L) has been identified and there is potential for high peak exposures. This is not the case.    

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:
no hazard identified

Additional information - workers

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

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
DNEL related information
Dose descriptor starting point:
NOAEL
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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

A GLP-and OECD-compliant neurotoxicity study was conducted (please see chapter 7.9.1). Based on these results no compound-related effects were reported at any dose with respect to locomotor activity testing or FOB parameters (including home cage, handling, open field, sensory, neuromuscular, or physiological observations). EFSA (2009) concluded that the results of this study are sufficient to address the behavioral concerns previously raised, and provide evidence for a NOAEL of 1,000 mg/kg body weight/day in the original toxicity study (i.e., WIL, 2001). A NOAEL of 1 ,656 mg/kg body weight was determined based on a lack of adverse physiological or behavioral effects following this 13 week exposure via drinking water in the follow-up neurological study.

Exposure to taurine is unavoidable as it is a natural constituent of the body and is present in foods of animal origin. Spitze et al. (2003) determined the taurine content of a variety of foodstuffs. Animal muscle tissue, particularly fish flesh, contained high concentrations of taurine. The mean daily exposure to taurine from omnivore diets has been estimated to range from 9–40 (lowest range values) to up to 200–400 mg/person per day (top range values) (Rana and Sanders, 1986; Laidlaw et al., 1990; Hayes and Trautwein, 1994).

The EFSA FEEDAP Panel estimated the Observed Safe Limit (OSL) in humans to be 6 g/person per day (corresponding to 100 mg/kg bw per day). Exposure resulting from the consumption of foodstuffs and "energy drinks" together would amount to about one-third of the OSL.

The highest, as well as the most recent, of the top range estimates is 400 mg/person per day (Hayes and Trautwein, 1994), equal to 6.7 mg/kg bw per day for a 60-kg person. This value is 150 times lower than the NOAEL of 1000 mg/kg bw per day in laboratory animals and 15 times lower than the human OSL (100 mg/kg bw per day).

Furthermore, taurine is used in more than 30 clinical investigations in humans in conditions including diabetes, epilepsy, congestive heart failure, hypertension, liver disease and cystic fibrosis, concluding that “No adverse health effects attributable to taurine have been reported over a period of 30 years. In many cases taurine has proved medically beneficial.”

 

Literature:

Hayes KC and Trautwein EA, 1994. Modern nutrition in health and disease. In: Taurine. Lea & Febiger, Philadelphia, 477–485 (cited in the SCF opinion 1999).

Laidlaw SA, Grosvenor M and Koppele JD, 1990. The taurine content of common foodstuffs. Journal of Parenteral and Enteral Nutrition, 14, 183–188.

Spitze AR, Wong DL, Rogers QR and Fascetti AJ, 2003. Taurine concentrations in animal feed ingredients; cooking influences taurine content. Journal of Animal Physiology and Animal Nutrition, 87, 251–262.

Rana SK and Sanders TAB, 1986. Taurine concentrations in the diet, plasma and breast milk of vegans compared with omnivores.British Journal of Nutrition, 56, 17–27.

Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population