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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

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 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.