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Diss Factsheets

Administrative data

Endpoint:
neurotoxicity: sub-chronic oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002
Reference Type:
review article or handbook
Title:
SCIENTIFIC OPINION The use of taurine and D-glucurono-γ-lactone as constituents of the so-called “energy” drinks. Scientific Opinion of the Panel on Food Additives and Nutrient Sources added to Food (Question No EFSA-Q-2007-113)
Author:
PANEL MEMBERS
F. Aguilar, U.R. Charrondiere, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R.
Guertler, G.E.N. Kass, J. Koenig, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D.
Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A.
Woutersen.
Year:
2009
Bibliographic source:
EFSA Journal (2009) 935, 1-31
Report date:
2009

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 424 (Neurotoxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Taurine
EC Number:
203-483-8
EC Name:
Taurine
Cas Number:
107-35-7
Molecular formula:
C2H7NO3S
IUPAC Name:
2-aminoethanesulfonic acid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on exposure:
Rats (20/sex/group) were administered 0, 600, or 1,000 mg taurine/kg body weight/day by gavage (in a deionized water vehicle) for 13 weeks.
Additional groups of rats (20/sex/group) were given drinking water at target doses of 0, 1 ,000, or 1 ,500 mg taurine/kg body weight/day [providing 0, 1 ,095, or 1 ,647 mg taurine/kg body weight/day (males) or 0, 1, 117, or 1,656 mg taurine/kg body weight/day (females)] for 13 weeks.
Duration of treatment / exposure:
13 weeks (90 days)
Frequency of treatment:
once daily
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (actual dose received)
Dose / conc.:
600 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Remarks:
administered in drinking water: actual mean taurine intake levels obtained with drinking water were 1095 and 1117 mg/kg bw/day for the males and females respectively.
Dose / conc.:
1 500 mg/kg bw/day (nominal)
Remarks:
administered in drinking water: actual mean taurine intake levels obtained with drinking water were 1647 and 1656 mg/kg bw/day for the males and females respectively.
No. of animals per sex per dose:
20
Control animals:
yes, concurrent vehicle

Examinations

Observations and clinical examinations performed and frequency:
Clinical examinations were performed daily.
Individual body weights and water consumption were recorded twice weekly and food consumption was recorded weekly.
Neurobehavioural examinations performed and frequency:
Detailed physical examinations were performed weekly.
Functional observational battery and locomotor activity data were recorded for all animals prior to the initiation of dose administration and during study weeks 0, 6 and 12.
Sacrifice and (histo)pathology:
Complete necropsies were conducted on all animals, and selected tissues and organs were collected at the scheduled necropsy.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
There were no test-article-related clinical findings.
Mortality:
no mortality observed
Description (incidence):
There were no test-article-related deaths.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No test-article-related effects were observed on body weights.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
No test-article-related effects were observed on food consumption.
Water consumption and compound intake (if drinking water study):
effects observed, non-treatment-related
Description (incidence and severity):
Some differences were observed in water consumption when rats were supplied taurine ad libitum in the drinking water. Increases in water consumption in the 1000 and 1500
mg/kg bw/day group males were noted only for study days 0 to 3 and/or 3 to 7 (both in g/animal/day and g/kg bw/day). The petitioner indicates that these differences were
considered test-article-related, but not considered adverse effects and that they occurred temporarily and were considered to reflect adaptation to the osmotic property of the test
article.
Gross pathological findings:
no effects observed
Description (incidence and severity):
There were no test-article-related macroscopic findings.
Neuropathological findings:
no effects observed
Description (incidence and severity):
There were no test-article-related effects on FOB parameters (home cage, handling, open field, sensory, neuromuscular and physiological observations).
Locomotor activity counts (total and ambulatory) and patterns were unaffected by test article administration.

Applicant's summary and conclusion

Conclusions:
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.