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:
other: Limited information on test item.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Name in test report: 82-0146, MX-6059, D-alpha-Tocopherol concentrate

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E. - Rabbits for research, Hewitt, N.J.
- Weight at study initiation: 2 - 4 kg
- Housing: housed individually in wire mesh bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- clipped with electric clippers
- prior to administration abrasion of the skin was performed on the exposure sites of 3 males and 2 females. The skin of the remaining 2 male and 3 female rabbits was left intact. Abrasions were made with the point of a 22 gauge disposable hypodermic needle. The abrasions were minor incisions through the stratum corneum that were not sufficiently deep to disturb the derma or to produce bleeding.
- Area of exposure:
- % coverage: occlusive
- Type of wrap if used: layer of plastic wrap, a protective cloth and stockinette binder, all securely held in place with masking tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wipped with clean gauze to remove as mucg non-absorbed test article as possible
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 5ml
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes constant concentration
Duration of exposure:
24 h
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality, local reactions, and toxicological findings were recorded for a total of 14 days. Body weights were recorded on the initial day of testing and at the study termination or day of death.
- Necropsy of survivors performed: no
- Other examinations performed: body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal was found dead on day 14.
Clinical signs:
Some animals showed decreased acitivity, loss of appetite, nasal discharge and diarrhea.
Body weight:
3 animals showed weight loss.
Gross pathology:
Left lung almost totally dark red in color. Stomach and intestines are gas filled. Both kidneys pale yellow. Urinary bladder full of urine.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal mediam lethal dose (LD50) of the test item in the rabbit was estimated to be greater than 5000 mg/kg body weight.
Executive summary:

The acute dermal toxicity of the test item was investigated in five female and 5 male New Zealand White rabbits.

Prior to administration abrasion of the skin was performed on the exposure sites of 3 males and 2 females. The skin of the remaining 2 male and 3 female rabbits was left intact. Abrasions were made with the point of a 22 gauge disposable hypodermic needle. The abrasions were minor incisions through the stratum corneum that were not sufficiently deep to disturb the derma or to produce bleeding.

One animal was found dead on day 14. Some animals showed decreased acitivity, loss of appetite, nasal discharge and diarrhea. Three animals showed weight loss.

The acute dermal median lethal dose (LD50) of the test item in the rabbit was estimated to be greater than 5000 mg/kg body weight.