Registration Dossier

Administrative data

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: Study conducted similar to OECD Guideline under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Although the common name is slightly different (OD-856) verse (OD-855), the test substance is the same. The distinction between the two common names is dependent upon the production/process method used.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats were obtained from Charles River Breeding Laboratories, Inc. Housing and Care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. Acclimation period of at least 5 days. Animals were fasted overnight prior to proceeding a single oral dose.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Single oral dose by gavage
Doses:
5.0 g/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Similar to OECD TG 401. Single oral dose 5 male/5 female rats with 15-day post-administration observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Based on:
test mat.
Mortality:
All animals survived the 15-day post observation period. No deaths occurred.
Clinical signs:
Effect Males Females
Salivation 3/5 4/5
Diarrhea 1/5 2/5
Decreased activity 1/5 1/5
Decreased Resp rate 0/5 2/5
Body weight:
Mean BW data
Initial Day 8 Day 15
Males: 306.4 364.4 394.6
+ or - 9.2 (5) + or - 10.1 (5) + or- 11.8 (5)

Females 220.6 247.6 255.2
+ or - 9.7 (5) +or- 13.1 (5) +or-14.7 (5)

Standard Deviation for the number of observations in ( ). The initial weight is based on fasted body weight.
Gross pathology:
All animals were subject to gross necropsy. There were no noteworthy findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, the acute lethal oral dose (LD50) of Molyvan 855 was estimated to be greater than 5 g/kg of body weight in male and female rats.