Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 Oct - 12 Nov 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
yes
Remarks:
occlusive dressing instead of semi-occlusive dressing
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sprague-Dawley® rats [SAS:V AF®(SD)] obtained from SASCO, Inc., Stone Ridge (Kingston), NY
- Age at study initiation: male rats were 8 weeks of age and female rats were 10 weeks of age
- Weight at study initiation: male rats weighed 206 to 220 grams and female rats weighed 210 to 214 grams
- Housing: Animals were housed in an American Association for Accreditation of Laboratory Animal Care-accredited vivarium·in accordance with the Guide for the Care and Use of Laboratory Animals, singly housed in suspended, stainless-steel, wire mesh cages. Cages and racks were washed once a week. Absorbent paper, used to collect excreta, was changed at least three times a week.
- Diet: Certified Rodent Diet (Purina Rodent Chow #5002, pellets) was available ad libitum.
- Water: ad libitum through an automatic watering system. The source of the water was the local public water system. There have been no contaminants identified in periodic water analyses that would be expected to interfere with the conduct of the study. Semi-annual analyses of water are maintained on file within the testing laboratory.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 48-62
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 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.
- Type of wrap if used: occlusive wrap

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of the exposure period, any residual test material was removed with running water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw, The test substance was administered as a solid moistened thoroughly with water.

VEHICLE
- Amount(s) applied: The test substance was administered as a solid moistened thoroughly with water.

Duration of exposure:
24 hours
At the end of the exposure period, any residual test material was removed with running water.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were measured on Days O (prior to treatment), 7, and 14.
- Necropsy of survivors performed: yes, All animals were euthanatized and necropsied at the completion of the 14-day observation period.
- Other examinations performed: Animals were observed at least once during the exposure period, and once each day thereafter for the duration of the experiment. Observations included, but were not limited to, 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.

Statistics:
No statistical procedures were required during the study.

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:
In the dermal toxicity study, no mortality was noted.
Clinical signs:
Discoloration (Black) of the hair was observed immediately adjacent to the application site in all rats (male and female).
Body weight:
All animals gained weight during both weeks of the study.
Gross pathology:
Treatment-related changes seen at necropsy were limited to discoloration (black) of the hair adjacent to the application site of all animals. Hydrometra was an incidental finding noted in one female rat. No tissue was collected for microscopic examination.
No signs of organ toxicity were observed. All rats survived until scheduled sacrifice at the end of the observation period.

Any other information on results incl. tables

Table 1: Overview Results

Dose

Number of rats (male/female)

Number of Deaths after 14 days (male/female)

2000 mg/kg bw

5/5

0/0

Applicant's summary and conclusion

Interpretation of results:
other: no classification required according to Regulation (EC) 1272/2008.
Conclusions:
The acute dermal median lethal dose (LD50) of the test substance in male and female Sprague-Dawley strain rats was > 2000 mg/kg bw.
The available data on acute dermal toxicity of the test substance do not indicate requirement of classification according to Regulation (EC) 1272/2008.