Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Conducted prior to GLP, and the availability of OECD guidelines. No information on the purity of the test sample. No information on temperature and humidity) Test was conducted on abraded skin. No information on the size of test site. Animals were immobilised while it is not a recommended method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity in the rabbit (abraded skin)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2-3 kg
- Fasting period before study: No data
- Housing: Individually, in screen bottom cages
- Diet (e.g. ad libitum): continuous access to commercial laboratory feed
- Water (e.g. ad libitum): continuous access to water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): air conditioned
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: No data To: No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: moistened with physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: No data
- % coverage: 100%
- Type of wrap if used: rubber sleeve closely fastened for 24 hours
- Test site abraded

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: No data
- For solids, paste formed: moistened with physiological saline

VEHICLE
- Amount(s) applied (volume or weight with unit): No data
Duration of exposure:
24 hours
Doses:
2 g/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
- Animals were imobilized during exposure.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made hourly for 5 hours after treatment initiation and twice daily for the remainder of the observation period.
- Necropsy of survivors performed: yes
Statistics:
No further data

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: One female died on day 2
Mortality:
One female died on day 2
Clinical signs:
None observed and no signs of skin irritiation.
Body weight:
All animals gained weight during the study.
Gross pathology:
The liver of one male had white areas, possible tapeworm migration scars. No visible lesions were found in any of the other male test animals.
The liver of one female was slightly pale with a nodule inguinal region (1.5 cm diameter) and another had tapeworm cysts in omentum and white area on liver, probably tapeworm migration scars. No other visible lesions were found in any of the other female animals.
Other findings:
No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 was found to be >2.0 g/kg body weight. Therefore it does not warrant classification of acute dermal toxicity according to current EU legislation.
Executive summary:

In a study conducted by Thompson (1979) the test substance, Busan 11-M1, was tested for its ability to cause acute dermal toxicity when applied to male and female New Zealand White albino rabbits. The exposure site on each test animal was shaved and abraded prior to application of the test material and the test substance moistened with physiological saline was applied. A rubber sleeve wrap was applied to the test site and remained in place for the 24 hours exposure period. During this exposure period, the test animals were immobilised. Following exposure, the test animals were placed in cages for the 14 day observation period. Under the conditions of this study, the dermal LD50 of Busan 11-M1, was determined to be >2.0 g/kg bw, equivalent to 2000 mg/kg bw. Based on this result, the test substance does not warrant classification for acute dermal toxicity in accordance with Regulation EC No. 1272/2008.