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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted by GLP accredited lab according to OECD method n. 401

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
No. of animals per sex per dose:
5
Statistics:
slope of log10(dose) = 11.3 for combined sexes with standard error deviation = 3.24

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 621 mg/kg bw
Based on:
test mat.
95% CL:
> 1 272 - < 2 087

Any other information on results incl. tables

In the dose ranging study all animals died at 5000 and 2500 mg/kg and one female at 1250 mg/kg died within 3 days of dosing.

Common abnormalities noted at necropsy were darkening and thickening of the stomach glandular mucosa and a pink colouration of the mucosa. There were several incidences of occular damage and discoloration of the undersurface of the lobes of the liver.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
harmful is swallowed