Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Acute Dermal Toxicity Study in Rabbits - Limit Test 2-2-3/3-23-89/REV 3
Deviations:
not specified
Principles of method if other than guideline:
n/a
GLP compliance:
yes
Test type:
other: Acute Dermal Toxicity Study in Rabbits - Limit Test 2-2-3/3-23-89/REV 3
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Sponsor's identification
Description
Batch number
Date received
Storage conditions
PCMX
cream coloured, crystalline solid
285/13847
27 September 2001
room temperature, in the dark
Specific details on test material used for the study:
The test material, OTTAS Extra B-9112162 ( hereafter refer red to as OTTAS Extra ) , was a white, crystalline-like powder and was stored at room temperature throughout the study in a square, clear glass jar with a black plastic lid . The test material was returned to the sponsor following the completion of testing.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
This standardized procedure was conducted according to the general conditions of the protocol and specifically as designated on the Project Instruction Sheet and Supplemental Instructions , as applicable. As such, it satisfies the criteria established by the Federal Insecticide, Fungicide, and Rodenticide Act ( 40 CFR ) , the Toxic Substances Control Act ( 40 CFR ) , and the OECO Guidelines.

Young adult , New Zealand White rabbits weighing between 2698 and 3438 grams at the start of the study were used .

The test material , as received, moistened with an appropriate volume of physiological saline, was administered to five male and five female rabbits at a dose level of 2.0 g/kg.

When applicable , the following classification for rating of hazard potential ( 40 CFR 156 , Proposed ) will be used:

1. Category I - Up to and including 200 mg/kg
2. Category II - Greater than 200 mg/kg thru 2000 mg/kg
3. Category III - Greater than 2000 mg/kg thru 5000 mg/kg
4. Category IV - Greater than 5000 mg/kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: physiological saline or other appropriate solvent
Details on dermal exposure:
Shortly prior to dosing, the hair of each rabbit will be closely clipped f rom the ventral area of the trunk using an electric clipper , so as to expose at least 10% of the body surface area.
Animals will be weighed shortly before dosing in order to calculate doses.
The sample will be applied at the selected dose to ten rabbits ( five/sex ) . Liquids may be administered as received. Powders or particulates will be moistened with physiological saline or other appropriate solvent .The time of application will be documented.
The test material will first be applied either directly to the animal or to a sleeve of rubber dental dam. which will be wrapped around the animal and secured with staples. An outer layer of porous gauze dressing may then be wrapped around the trunk of the animal and secured with tape. The animal will then be fitted with an appropriate restraining device to prevent removal of the wrapping.
At the end of the approximate 24-hour period, the wrapping will be removed and any unabsorbed sample removed by gentle sponging using a towel moistened with water or other appropriate solvent. The presence or absence of residual of sample on the wrapping and on the rabbits will be documented on completion of exposure.
Duration of exposure:
Animals will be observed for signs of toxicity and behavioral changes once (more frequently if clinical signs are present) on the day of treatment . All surviving rabbits will be maintained for at least 14 days following completion of the exposure period. Examinations for gross signs of toxicity will be carried out once daily with an additional check for viability during the day.
Doses:
The test material , as received, moistened with an appropriate volume of physiological saline, was administered to five male and five female rabbits at a dose level of 2.0 g/kg.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Animals will be observed for signs of toxicity and behavioral changes once (more frequently if clinical signs are present) on the day of treatment . All surviving rabbits will be maintained for at least 14 days following completion of the exposure period. Examinations for gross signs of toxicity will be carried out once daily with an additional check for viability during the day. Observations will be made for erythema, edema, atonia, desquamation, necrosis, coriaceousness, fissuring and for other evidence of irritation or injury once daily. All appropriate observations and times of observations will be documented. AM/PM time designations will be used .

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 other: g/kg
Based on:
test mat.
Remarks on result:
other:
Mortality:
0
Clinical signs:
0
Body weight:
+45m, +158f
Gross pathology:
0
Other findings:
A report will include (but may not be limited to) identification of the animals and test procedure, protocol deviations if any, a description of the test material (including date of receipt, color and form), concentration of sample, solvent, dosage level, body weight data for each animal, tabulation of mortalities, appropriate in-life observations, necropsy observations, and
dermal observations

Any other information on results incl. tables

The acute dermal LD50 value was found to be greater than 2.0 g/kg in male and female  New  Zealand  White  rabbits.  The  test  material   is  classified   in Toxicity Category III (40 CFR 156, Proposed )  by dermal administration.

Applicant's summary and conclusion

Interpretation of results:
other: it satisfies the criteria established by the Federal Insecticide, Fungicide, and Rodenticide Act ( 40 CFR ) , the Toxic Substances Control Act ( 40 CFR ) , and the OECO Guidelines.
Conclusions:
The acute dermal LOSO value was found to be greater than 2. 0 g/kg in male and female New Zealand White rabbits. The test material is classified in Toxicity Category III (40 CFR 156, Proposed ) by dermal administration.
Executive summary:

The acute dermal LD50 value was found to be greater than 2.0 g/kg in male and female  New  Zealand  White  rabbits.  The  test  material   is  classified   in Toxicity Category III (40 CFR 156, Proposed )  by dermal administration.