Taurine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.05.1994 - 31.03.1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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 material form:

solid: crystalline

Specific details on test material used for the study:

For this assay, two batches have been tested.

Batch 1: O1SRM
Purity (hydroxide titration): 99.5 %
Appearance: white crystalline powder

Batch 1: 302-3
Purity (hydroxide titration): 99.4 %
Appearance: white crystalline powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Kent, UK
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 5 weeks
- Weight at study initiation: 110-141 g(m), 106-132 g(f)
- Fasting period before study: overnight
- Housing: groups up to five
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12 / 12 h

IN-LIFE DATES: From: day 1 To: day 15

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg
- Justification for choice of vehicle: standard
- Lot/batch no. (if required): -
- Purity: reverse osmose tap water

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:

1000, 2000 mg/kg

No. of animals per sex per dose:

5 (M), 5 (f)

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: signs and mortality (twice daily), bw: day 1, 3, 5, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, plasma levels (satellite groups)

Statistics:

Homogeneity of variance was tested for organ weights using Bartlett's test. If this was found to be stati statistically significant, a Fisher-Behrens test was used to perform pairwise comparisons, otherwise Dunnett 's test was used.
Inter-group differences in the incidence of macro- or micropathological lesions were assessed by the Fisher Exact Probability test.
Two-tailed analyses were undertaken unless otherwise indicated.
Levels of statistical significance were chosen as p < 0.05 (a) and p < 0.01 (b). Inter-group differences that were
not statistically significant (p > 0.05) are not annotated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no effects

Clinical signs:

other: no effects

Gross pathology:

no effects

Other findings:

no effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study it is concluded that the 'no-effect 'level and the LD50 of Taurine exceed 2000 mg/kg for both materials tested and there was no apparent difference in the toxicities of MTC Taurine A and MTC Taurine B.