Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
- Principle of test: Male and female rats were exposed to the test item in peanut oil DAB 7 (1:1). The treatment was applied to shaved skin and kept under occlusion for 24 hours. The treated area was then washed with water and rats were observed for 14 days.
- Short description of test conditions: Experimental conditions were maintained at 23 to 33 °C with 45 to 75 % relative humidity. Five male and five females rats were used per treatment and control. Animals were individually caged and provided with food and water ad libitum.
- Parameters analysed / observed: Mortality, intoxication symptoms, local changes, body weight
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Wistar-AF/HAN-EMD-SPF
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 125 to 143 g (mean 137 g)
- Housing: Individually caged in wire cages Type III.
- Diet (e.g. ad libitum): Altromin R, ad libitum.
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 33 °C
- Humidity (%): 45 to 75 %

Administration / exposure

Type of coverage:
occlusive
Vehicle:
peanut oil
Remarks:
DAB 7
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: The treated skin area was covered with tin foil, which was fixed and sealed with the aid of a rubber sleeve.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, substance residues were washed off with water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 10 mL/kg body weight
- Concentration: 50%
- Constant volume or concentration used: Constant concentration used.

VEHICLE
- Amount(s) applied: 10 mL/kg bodyweight
- Concentration: 50%
Duration of exposure:
24 hours
Doses:
10 g/kg body weight
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rats were observed and weighed daily, Monday through Friday.
- Other examinations performed: Evaluation of the changes occurring in the application area was made according to Draize.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortalities were recorded.
Clinical signs:
There were no signs of absorptive intoxication and no symptoms of irritation were observed.
Body weight:
All rats lost weight in the first two days after application. Animals gained weight continuously thereafter.
Gross pathology:
No pathoanatomical abnormalities were observed.

Any other information on results incl. tables

Table 1. Body weights

 Dose (mg/kg)  Sex  Mean body weight (g)                 Difference of final weight from starting weight (g)
     0 days  1 day  3 days  7 days  10 days  14 days  
Vehicle  Male  139  123  132  154  168  187  +48
 Vehicle  Female  142  126  139  148  157  166  +24
 10000  Male  133  117  129  152  165  186  +53
 10000  Female  141  126  136  145  153  161  +20

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The dermal LD50 in rats was determined to be > 10000 mg/kg bodyweight.
Executive summary:

The acute dermal toxicity of the test item was determined in a 14 -day limit test. A nominal concentration of 10 g/kg bodyweight test item in peanut oil DAB 7 (1:1) was applied to a 6 x 6 cm area of shaved skin of male and female Wistar-AF/HAN-EMD-SPF rats. A vehicle control was included in the study. The treated area was occluded for 24 hours, after which substance residues were washed off with water. Rats were observed for mortality, intoxication, local changes and body weight. The LD50 was determined to be > 10 g/kg bw. There were no signs of absorptive intoxication, symptoms of irritation or pathoanatomical abnormalities. All rats lost weight in the first two days after application, however weight gain was continuous thereafter. This study is considered reliable with restriction (Klimisch 2) as the test was conducted similar to OECD Guideline 402, with minor limitations in reporting.