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Toxicological information

Acute Toxicity: dermal

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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: Non-guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

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 animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2.15-2.93 kg
- Fasting period before study:
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): approximately 115 g daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55-75
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: plastic sheet


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: test material removed 24 hours after exposure


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg bw
- Concentration (if solution):
- Constant volume or concentration used: 11.1 ml
- For solids, paste formed:


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: nasal passages, trachea, bronchi, heart, lungs, liver, kidneys, adrenal glnds, spleen, gonads, gastrointestinal tract, bladder, body fat and skin.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None
Clinical signs:
Reduced food consumption and decreased motor activity.
Body weight:
Body weights of treated males and females were significantly less than control on days 7 and 14.
Gross pathology:
Microscopic examination of the treated skin showed diffuse subacute dermatitis. No gross pathological changes observed at necropsy other then skin effects were evident.

Applicant's summary and conclusion

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

 

ACUTE DERMAL TOXICITY: FIVE RABBITS OF EACH SEX WERE TREATED WITH A SINGLE DERMAL APPLICATION OF 5.0 G/KG OF THE UNDILUTED TEST MATERIAL. NO DEATHS OCCURRED DURING THE STUDY. SIGNS OF TOXICITY OBSERVED WERE REDUCED FOOD CONSUMPTION AND DECREASED MOTOR ACTIVITY. THE BODY WEIGHTS OF THE TREATED MALES AND FEMALES WERE SIGNIFICANTLY LESS THAN THE CONTROLS AT 7 AND 14 DAYS. AT AUTOPSY, NO GROSS PATHOLOGICAL CHANGES OTHER THAN SKIN EFFECTS WERE OBSERVED THAT COULD BE ATTRIBUTED TO THE TEST MATERIAL.