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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 January 2005 - 2 February 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
lithium(1+) [2-methoxy-4-(trifluoromethyl)pyridin-3-yl]sulfanide
EC Number:
617-976-4
Cas Number:
871544-06-8
Molecular formula:
C7H5NOF3S.Li
IUPAC Name:
lithium(1+) [2-methoxy-4-(trifluoromethyl)pyridin-3-yl]sulfanide
Details on test material:
3-Pyridinethiol, 2-methoxy-4-(trifluoromethyl)-lithium salt
Appearance: dark brown aqueous solution
Storage: room temperature
pH: 11 - 12 (by wetted pH paper)
Solubility: soluble in water, methanol, ethanol, and acetone. Mineral oil: 3-Pyridinethiol, 2-methoxy-4-(trifluoromethyl)-lithium salt soluble, aqueous solution not soluble.
Stability: test substance was expected to be stable for the duration of testing

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC
- Age at study initiation: 9 weeks
- Weight at study initiation: Males 194 - 203 g; Females 128 - 140 g
- Housing: The animals were individually housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Certified Rodent Diet (PMI #5002)
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum by an automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analysis of the water is conducted at least once a year and the records are kept on file at Product Safety Laboratories. The most recent analysis was conducted in December 2004. Purina Certified Rodent Diet, PMI #5002, Lot Number: NOV 23 04 3A, was analyzed in December 2004.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 30-55% relative
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The sample was applied as received. Five thousand mg/kg of body weight of the test substance was applied evenly over a shaved dose area of approximately 2 inches x 3 inches (approximately 10% of the body surface) and covered with a 2-inch x 3-inch, 4-ply gauze pad. The gauze pad and entire trunk of each animal were then wrapped with 3-inch Durapore tape to avoid dislocation of the pad and to minimize loss of the test substance.

After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed of any residual test substance.
Duration of exposure:
24 hours, followed by a 14 day observation period.
Doses:
5000 mg/kg/bw
No. of animals per sex per dose:
5 male
5 female
Control animals:
no
Details on study design:
-Preparation and Selection of Animals
On the day prior to application, a group of animals was prepared by clipping (Oster model #A5-small) the dorsal area and the trunk. After clipping and prior to application, the animals were examined for health, weighed (initial) and the skin checked for any abnormalities. Ten healthy rats were selected.
-Dose Calculations
Individual doses were calculated based on the initial body weights, taking into account the specific gravity (determined by PSL) of the test substance.
-Application of Test Substance
After the application, rats were returned to their designated cages. The day of application was considered Day 0 of the study.
After 24 hours of exposure to the test substance, the pads were removed and the test sites were gently cleansed of any residual test substance.
-Body Weights
Individual body weights of the animals were recorded prior to test substance application (initial) and again on Days 7 and 14 (termination).
-Cage-Side Observations
The animals were observed for mortality, signs of gross toxicity, and behavioural changes during the first several hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, and coma.
-Necropsy
All rats were euthanized via CO2 inhalation on Day 14. Gross necropsies were performed on all animals. The external surface of the body and all orifices, tissues, and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There were no mortalities, signs of gross toxicity, dermal irritation, adverse clinical signs, or abnormal behaviour.
Mortality:
There were no mortalities.
Clinical signs:
other: All animals appeared active and healthy during the study. There were no signs of gross toxicity, dermal irritation, adverse clinical signs, or abnormal behaviour. A brown stain was observed on the dose site.
Gross pathology:
No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.

Any other information on results incl. tables

Individual Body Weight and Doses:

Animal

No.

Sex

Body weight (g)

Dose*

Initial

Day 7

Day 14

mL

9943

M

203

233

259

0.93

9944

M

199

228

256

0.91

9945

M

194

219

250

0.89

9946

M

197

224

261

0.90

9947

M

200

233

266

0.92

9948

F

140

151

170

0.64

9949

F

132

139

164

0.61

9950

F

128

136

169

0.59

9951

F

133

144

173

0.61

9952

F

140

147

172

0.64

*Specific gravity 1.090 g/mL

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the acute dermal LD50 of the test substance was determined to be greater than 5,000 mg/kg of body weight in male and female rats.
Executive summary:

Under the conditions of this study, the acute dermal LD50 of the test substance was determined to be greater than 5,000 mg/kg of body weight in male and female rats. The study was conducted in accordance with U.S. EPA Health Effects Test Guidelines, OPPTS 870.1200 (1998).