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Description of key information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to information in OECD SIDS (2002)
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Age of the animals at study initiation: 5 weeks old
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
for injection
Doses:
0, 500, 1,000, 2,000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Control animals comprised a concurrent vehicle control group
Statistics:
Not applicable, because of no fatality. 
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No treatment related clinical sign observed.
Body weight:
No compound-related effect was observed. Body weight changes in treated groups were similar to that of the control.
Gross pathology:
No treatment-related abnormalities.
Other findings:
There was no treatment-related adverse effect.
Interpretation of results:
other: LD50 > 2000 mg/kg body weight
Conclusions:
There were no treatment related abnormalities. LD50 is greater than 2,000 mg/kg for both sexes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

Both acute oral toxicity studies demonstrated that the LD50 of THEIC is higher than the limit dose of 2000 mg/kg b.w.

As detailed in the respective justifications for data waiving, the conduct of acute dermal or inhalation toxicity studies would not have added relevant toxicological hazard information.

Justification for classification or non-classification

In both acute oral toxicity studies, all animals survived the dose of 10000 mg/kg or the limit dose of 2000 mg/kg. Therefore, classification of THEIC for acute oral toxicity is not required [REGULATION (EC) 1272/2008].

 

Non-classification of THEIC by the dermal route was reasonable, because of the absence of effects indicative of severe cytotoxicity, relevant systemic toxicity and/or local irritation in all available in vitro and in vivo toxicity studies with THEIC and the systemic exposure probably being higher by the oral than by the dermal administration route.

 

Non-classification of THEIC by the inhalation route was reasonable, because any inhaled dose of THEIC would become available systemically rather than inducing local irritation, and because the dose achievable in a traditional acute limit test with 4 hours inhalation exposure at 5 mg/L air (OECD 403) is lower than the doses of THEIC tested in both acute oral toxicity studies. In addition, the attainable acute inhalation limit dose is considerably lower than the NOAEL attained in the Combined Repeated Dose Toxicity Study with Reproduction / Developmental Toxicity Screening Test (OECD 422) in rats treated with THEIC for 40 to 49 consecutive days.