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Description of key information

OECD 401: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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
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.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no effects
Clinical signs:
no effects
Body weight:
no effects
Gross pathology:
no effects
Other findings:
no effects
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the available information, no classification is needed.