Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzefeld, Germany
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: males (mean): 308.92 g, females (mean): 193.28 g
- Housing: 2 rats of same sex per cage, wooden absorbing bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): fully airconditioning
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw
- Concentration (if solution): 0.5mg test item in 400µl corn oil
- Constant volume or concentration used: no
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: untreated skin of same animal
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day, once on weekends
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Means and standard deviation were calculated using standard statistical tests.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred
Mortality:
not observed
Clinical signs:
slight signs of general discomfort as often seen in dermal toxicity studies, the general health status was good throughout the study
Body weight:
treatment related effects were not observed
Gross pathology:
no abnormalties detected

Any other information on results incl. tables

During the present study no mortality occured and there were no indications of systemical toxicity, no effects regarding the body weight and neither clinical signs nor pathological findings observed. The LD50 is therefore estimated to be > 2000mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Executive summary:

2000 mg/kg bw of the test item were semiocclusively administered for 24 hours as pasty formulation in corn oil to the shaved and defaffed back of

5 female and 5 male rats. After the end of the 24 -hour exposure period the test item paste was recovered as effectively as possible using water and the animals were observed for 14 days.

During the present study no mortality occured and there were no indications of systemical toxicity, no effects regarding the body weight and neither clinical signs nor pathological findings observed. The LD50 is therefore estimated to be > 2000mg/kg bw.