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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
Study period:
October 2002 - October 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500.40
Deviations:
not specified
Principles of method if other than guideline:
The purpose of this study was to assess the Toxicological profile of test item to a single administration via dermal route to rabbits.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: A single dose of the test article was applied to the prepared site, under a 4 ply porous gauze dressing measuring 10 x 15 cm
- Type of wrap if used: The torso was wrapped with plastic which was secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped (not washed) prior to making dermal evaluations.
- Time after start of exposure:24 hours

TEST MATERIAL
- Concentration (if solution): The dose was based on the sample weight as calculated from the specific gravity.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal responses were recorded 24 hours postdose and on days 7 and 14. Animals were observed for mortality, toxicity and pharmacological effects once daily for 14 days. Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time.
- Necropsy of survivors performed: yes, All animals were humanely sacrificed using CO2 following study termination.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived at the 2000 mg/kg dermal application.
Clinical signs:
Dermal responses were absent to slight at 24 hours and absent on days 7 and 14. There were no abnormal physical signs noted during the observation period.
Body weight:
Body weight changes were normal.
Gross pathology:
Not examined

Any other information on results incl. tables

Dose level: 2000 mg/kg bw

Time periods

G1965 M

G1966 M

G1967 M

G1968 M

G1969 M

G1994 F

G1995 F

G1996 F

G1997 F

G1998 F

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No entry indicates animal appeared normal at that observation period.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The lethal concentration (LD50) value for acute dermal toxicity test was considered to be >2000 mg/kg bw, when male and female New Zealand White rabbits were treated with test chemical to the dermal application semiocclusively according to 16 CFR 1500.40.
Executive summary:

The acute dermal toxicity profile of the given test chemical was conducted according to 16 CFR 1500.40 in male and female New Zealand White rabbits.

A single dose of the test chemical was applied to the prepared site, under a 4 ply porous gauze dressing measuring 10 x 15 cm at a dose level of 2000 mg/kg. The dose was based on the sample weight as calculated from the specific gravity. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The torso was wrapped with plastic which was secured with non-irritating tape. The test chemical remained in contact with the skin for 24 hours at which time the wrappings were removed and an estimate of the amount of test article remaining was made. The sites were wiped (not washed) prior to making dermal evaluations.

Dermal responses were recorded 24 hours postdose and on days 7 and 14. Animals were observed for mortality, toxicity and pharmacological effects once daily for 14 days. Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time. All animals were humanely sacrificed using CO2 following study termination.

All animals survived at the 2000 mg/kg dermal application. Dermal responses were absent to slight at 24 hours and absent on days 7 and 14. There were no abnormal physical signs noted during the observation period. Body weight changes were normal.

Under the condition of the study, the lethal concentration (LD50) value for acute dermal toxicity test was considered to be >2000 mg/kg bw, when male and female New Zealand White rabbits were treated with test chemical to the dermal application semiocclusively according to 16 CFR 1500.40.