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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 420 and GLPs.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Resin acids and Rosin acids, hydrogenated, potassium salts
EC Number:
273-572-4
EC Name:
Resin acids and Rosin acids, hydrogenated, potassium salts
Cas Number:
68990-01-2
IUPAC Name:
68990-01-2
Details on test material:
-Test material (as cited in report): Resin acids and Rosin acids, hydrogenated, potassium salts
-Batch/Lot number: X29363-079
-Physical state: Solid, tan chunks
-Supplier: Eastman Chemical Company, Kingsport, Tennessee, USA

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
-Source: Charles River Laboratories, Stone Ridge (Kingston), NY
-Sex: female
-Acclimation period: 5 days
-Age at study initiation: 8-9 weeks
-Weight at study initiation: 178-190 g
-Housing: individually in suspended, stainless-steel, wire-mesh cages
-Diet: Certified Rodent Diet (PMI #5002), pellets; ad libitum
-Water: Rochester, New York public water, ad libitum
-Method of animal identification: uniquely-numbered metal ear tags
-Method of animal distribution: Animals were randomly selected and assigned to dose groups from the same shipment using a computer-generated list. After assignment, body weights were determined to ensure that individual body weights were within 20% of the mean weight.

ENVIRONMENTAL CONDITIONS:
-Temperature (°C): 21.6-24.2
-Humidity (%): 40.6-51.2
-Photoperiod: 12 hours light/12 hours dark cycle

IN-LIFE DATES:
-Experimental Start Date: 2004-11-15
-Experimental Completion Date: 2004-12-01

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test substance was administered as a 3% suspension in corn oil for the initial dose of 300 mg/kg bw and as a 20% suspension in corn oil for the 2000 mg/kg bw doses. The test substance was administered as a single dose by oral gavage to rats that had been fasted overnight. Data from a sighting study were used to establish the dose level for the main study.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw (1 female rat) and 2000 mg/kg bw (5 female rats)
Control animals:
no
Details on study design:
Clinical observations:
Animals were observed three times on the day of dosing (Day 0), and once each day thereafter for the duration of the experiment. Observations included examination of the hair, skin, eyes, mucous membranes, motor activity, feces, urine, respiratory system, circulatory system, autonomic nervous system, central nervous system, and behavior patterns.

Body weights:
Body weights were measured on Days 0 (prior to treatment), 7 and 14.

Necropsy:
All animals were euthanized and necropsied at the completion of the 14-day observation period.
Statistics:
No statistical analysis was required during the study. No dose/mortality curve was constructed because of the limited number of animals and dose groups.

Results and discussion

Preliminary study:
In a preliminary sighting study, an initial dose of 300 mg/kg bw of the test material was administered to a single female rat. Abnormal clinical signs were limited to softened feces noted for this animal so a higher dose of 2000 mg/kg bw was administered to a second female rat. Based on an absence of clinical signs or mortality, 2000 mg/kg bw was administered to 4 additional female rats.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the 14-day observation period.
Clinical signs:
The one rat administered the dose of 300 mg/kg bw produced softened feces the day after test substance administration. No other abnormal clinical signs were noted for this animal. All animals administered the dose of 2000 mg/kg bw appeared normal throughout the study.
Body weight:
All animals gained weight normally over the 14 day observation period.
Gross pathology:
No treatment-related changes were observed at necropsy and no tissues were collected for microscopic examination.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
When Resin acids and Rosin acids, hydrogenated, potassium salts was administered by gavage to female rats at a dose level of 2000 mg/kg bw, no deaths or significant systemic effects were observed. The oral LD50 value for female rats was > 2000 mg/kg bw.

Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for acute oral toxicity in Annex I of Directive 67/548/EEC. Based on the oral LD50 value of greater than 2000 mg/kg bw, Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for acute lethality by the oral route according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) defines a fifth category for acute toxicity for chemicals with oral LD50 values between 2000 and 5000 mg/kg bw. Insufficient data were available from this study to provide a definitive classification under UN GHS. Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for target organ toxicity in Annex I of Directive 67/548/EEC. Resin acids and Rosin acids, hydrogenated, potassium salts is not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for Specific Target Organ Toxicity – Single Exposure.
Executive summary:

In a fixed-dose acute oral toxicity study, 1 female rat was administered a single dose of 300 mg/kg bw of Resin acids and Rosin acids, hydrogenated, potassium salts by gavage. The only clinical effect noted was softened feces on the day following dosing. An additional 5 female rats were administered single oral gavage doses of 2000 mg/kg bw followed by a 14-day observation period. Under the conditions of this study, no deaths occurred and the oral LD50 value was determined to be > 2000 mg/kg bw. No abnormal clinical signs were observed in the rats dosed at 2000 mg/kg bw. Body weight gain was normal for all animals over the 14-day observation period. Based on the results of this study, Resin acids and Rosin acids, hydrogenated, potassium salts is relatively harmless by the oral route.