Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analysis carried out by a recognised testing laboratory by trained staff under controlled conditions. Full data relating to necropsy and body weight not available. Details of % active not included.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Remarks:
Performed under Good Laboratory Practice Regulations (21 CFR Part 58) and in accordance with standard operating procedures and applicable standard protocols. The QAU maintains copies of study protocols and standard operating procedures.
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solution
Details on test material:
TEST ARTICLE: ColaMoist 200 Lot# 1296SA06
TEST ARTICLE RECEIPT DATE: November 15, 2006
The test article was used as received (Sp.g. = 1.1S)
The test article arrived at this facility as a light amber liquid. The intended use and/or application of the test article is unknown by this facility.
Characterization of the test article was not performed by this facility.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Six (3M:3F), Sprague Dawley strain, albino rats were used for this test. Animals were obtained from Ace Animals in Boyertown, Pennsylvania and used in equal numbers of each sex, at approximately 6 to 8 weeks of age and between 200 and 300 grams. The weight variation of animals used did not exceed ± 20% of the mean weight for each sex. Upon receipt, the animals were carefully checked for respiratory difficulty, ocular or nasal lacrimation, dehydration, diarrhea, and general condition.
The animals were acclimated for nine (9) days prior to test initiation. They were housed in stainless steel cages with indirect bedding, in a temperature controlled room, with a 12 hour light/dark cycle. The temperature was controlled to comply with Animal Welfare regulations with an approximate range of 60° to 85° F. Diet consisted of Lab Diet Certified Rodent Diet #5002, as well as water ad libitum. There are no known contaminants that are reasonably expected to be present in animal feed or water at levels sufficient to interfere with this study.
The following day, after approximately 18 hours of fasting, each rat was weighed and marked with an ear clip. Individual doses, calculated on the basis of body weight and the dose level being administered, were given using a stainless steel intragastric feeding needle of sufficient bore to allow even passage of the test article in its dosing form. The rats were then returned to their cages, where food and water were available ad libitum. Each cage was uniquely labeled with respect to study number, test article, dose level, sex, animal number(s), and date of dosing.
Animals were observed for signs of pharmacological activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage. Observations were made at least once daily thereafter for a total of 14 days. Interim body weights were recorded on day seven (7).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
already in liquid form
Details on oral exposure:
Individual doses, calculated on the basis of body weight and the dose level being administered, were given using a stainless steel intragastric feeding needle of sufficient bore to allow even passage of the test article in its dosing form.
As the initial dose level at two (2) grams per kilogram body weight, using at least three (3) animals of each sex, indicated that the LD50 is greater than two (2) grams per kilogram, further testing may not be necessary
Doses:
2000 mg/kg of product
1400 mg/kg actives
No. of animals per sex per dose:
three male and three female rats used at this single dose of 2000 mg/kg bodyweight of Colamoist as received.
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 400 mg/kg bw
Based on:
act. ingr.
Mortality:
Animals were observed for signs of pharmacological activity and drug toxicity at 1, 3, 6 and 24 hours post-dosage. Observations were made at least once daily thereafter for a total of 14 days. Interim body weights were recorded on day seven (7).
All animals survived the observation period and were then euthanized and subjected to a gross necropsy with all findings noted. Sacrificing was accomplished via carbon dioxide asphyxiation.
Clinical signs:
There were no abnormal signs shown by any of the animals for the whole duration of the test (14 days)
Body weight:
All animals had increased their body weight during the testing period by about 50% for the males and around 30% for the females.
Gross pathology:
observed Necropsy comments: Animals #1-#6: No gross changes.
Full details are not available in the report.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification not required.
Although the 70% mixture was tested, this is considered to be valid in view of no effect being obsevered, allow a discriminating dose to be determined.
Executive summary:

The ColaMoist sample that was submitted for this test is commercial grade, based on a 70% active, which is the way that this product is provided and used commercially because the 100% substance is not possible to obtain without potential degradation.

It follows that in this case that the dosage used was 1400 mg/kg bw and not 2000 mg/kg bw as the test indicates.

The test report results show from the body weight and observation that there was absolutely no sign of any distress after administration of this substance up to 14 days after dosing, and the necropsy findings were reported to be negative (no gross changes). It is highly likely that at 100% active i.e. at 2000 mg/kg that there would be no discriminating toxicological effect as established at 1400 mg/kg.

Therefore the test result of orally non-toxic is expected to apply to 100% active material.