Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: BPL not indicated

Data source

Reference
Reference Type:
publication
Title:
Acute toxicity on 113 environmental chemicals
Author:
Hasegawa R. et al.
Year:
1989
Bibliographic source:
Sci. Rep.Res.Inst. Tohoku Univ., -C, Vol. 36, N° 1-4, 1989, pp 10-16

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Commercial source

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
1 week acclimation of 5 weeks animals

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
administration 16 hours afetr feed deprivation
Doses:
6 doses:
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 850 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 600
Based on:
test mat.

Any other information on results incl. tables

Also tested on male Sprague Dawley with arabic gum: LD50 = 1900 (1660 -2200)

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a well conducted LD50 study with wistar rats male(10) per dose / 6 doses and female (10), there is a slight difference between sexes (m1850 /f1600) leading by statistical analysis to a mean LD50 of 1725 mg/kg