Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Doses:
175, 55, 175, 550, 2000, 550, 2000, 550 mg/kg bw
No. of animals per sex per dose:
8

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
425.4 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the conditions of this study, the acute LD50 of IR9804 is estimated to be 425.4 mg/kg bw (based on maximum likelihood and an assumed sigma of 0.5) in female rats with a 95% PL (Profile-Likelihood based confidence interval) Confidence interval of 0 mg/kg (lower) to greater than 20,000 mg/kg (upper).