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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 402 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:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS:
-Source: Charles River Laboratories, Stone Ridge (Kingston), New York, USA
-Sex: male and female
-Acclimation period: 5 days
-Age at study initiation: 8 weeks (males); 10-11 weeks (females)
-Weight at study initiation: 244-261 g (males); 229-251 g (females)
-Housing: individually in suspended, stainless-steel, wire-mesh cages
-Diet: Certified Rodent Diet (Purina Rodent Chow #5002), pellets; ad libitum
-Water: local municipality, 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): 21.4-24.0
-Humidity (%): 40.2 - 61.5
-Photoperiod: 12 hr light/12 hr dark cycle

IN-LIFE DATES:
-Experimental start date: 2004-10-26
-Experimental completion date: 2004-11-09

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was received as a solid and was administered moistened with water. The hair was removed from an area of the dorsal skin with an electric clipper. A single dose of the test substance was placed in contact with the skin using a fiber pad and an occlusive wrap to hold the test substance in place for 24 hours. After 24 hours, any residual test substance was removed with running water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 rats/sex
Control animals:
no
Details on study design:
Clinical observations:
Animals were observed at least once during the exposure period, 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:
Statistical analyses were not performed on the test data because there were was no mortality observed.

Results and discussion

Effect levels
Sex:
male/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:
Clinical abnormalities consisted of brown discoloration by the test substance and desquamation of the skin at the application sites. No other clinical signs of toxicity were observed during the study.
Body weight:
All animals gained weight during both weeks of the study. Female rats gained an average of 27 g and male rats gained an average of 114 g during the 14-day study.
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 to the skin of male and female rats under occlusive contact for 24 hours, there were no deaths and no signs of systemic toxicity or irritation. The dermal LD50 value for male and female rats was > 2000 mg/kg bw.

Based on an acute dermal LD50 value of > 2000 mg/kg bw, Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for acute lethality by the dermal route according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for acute lethality by the dermal route in Annex I of Directive 67/548/EEC. Based on an absence of clinical signs. treatment-related changes at necropsy or signs of irritation after occlusive contact with the skin of male and female rats for 24 hours, Resin acids and Rosin acids, hydrogenated, potassium salts is not classifiable for Skin Irritation/Corrosion or Target Organ Toxicity - Single Exposure according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 or the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Resin acids and Rosin acids, hydrogenated, potassium salts is not classified for Target Organ Toxicity or Skin Corrosion/Irritation in Annex I of Directive 67/548/EEC.
Executive summary:

In an acute dermal toxicity study, 5 rats/sex were administered a single dose of 2000 mg/kg bw of Resin acids and Rosin acids, hydrogenated, potassium salts under occlusive contact for 24 hours. The animals were observed for mortality and adverse clinical signs for a period of 14 days. Under the conditions of this study, no deaths occurred and the dermal LD50 value was determined to be > 2000 mg/kg bw. No signs of skin absorption or systemic toxicity were evident during the study. At the application sites, clinical abnormalities consisted of brown discoloration by the test substance and desquamation of the skin. Body weight gains were noted for all animals over the 14-day observation period. Based on the results of this study, Resin acids and Rosin acids, hydrogenated, potassium salts presents a low toxicity hazard upon skin contact under conditions of normal use.