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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Acute, single dose
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
The substance is based on the natural amino acid taurine, but instead of having a primary amine, the amine is tertiary, with two ethanol groups.
Taurine is well evaluated as being of low hazard, but it is necessary to confirm that tertiary amines with ethanol are themselves of low toxicity
This endpoint considers a review by the US National Toxicity Programme.
No further animal testing can be justifed

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Precise methods not described, but considered valid in the review
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
No specific details on purity or source

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
In axcess of 9000 mg/kg
No. of animals per sex per dose:
Not specified
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
mortality from 8000 mg/kg
Clinical signs:
Not reported
Gross pathology:
The animals that died had effects gastrointestinal tract and included gastric dilatation, congestion with some hemorrhage in the stomach; these effects were concluded to be local damage and are consistent with other references suggesting toxicity is related to alkalinity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is of low acute toxicity with effects only seen at exceptionally high treatment levels.
The effects were concluded to be local damage and are consistent with other references suggesting toxicity is related to alkalinity.