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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: well performed study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

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
Type:
Constituent
Test material form:
other: solution
Details on test material:
- Name of test material (as cited in study report): Preventol CI 7-50
- Substance type: organic
- Physical state: solved
- Lot/batch No.: 150-5-45
- Storage condition of test material: tighty closed container

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Small Stock, Inc., Pea Ridge, Arkansas
- Age at study initiation: no data
- Weight at study initiation: 2.6 to 2.8 kg
- Fasting period before study: no
- Housing: stainless steel cages, individual
- Diet: Purina Rabbit Chow ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.33
- Humidity (%): 35 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: backs of animals
- Type of wrap if used: gauze, hypoallergenic tape, plastic, tape and elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with paper towel and water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, weighing on the day of treatment, 7 and 14 days after
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no statistics performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortalities occured
Clinical signs:
ataxia in all animals, salivation and a nasal discharge in some. These signs were not noted any longer at the 24-hour observation period.
Edema was noted only on day 1.
Erythema and discoloration of the back were apparent from day 1 to day 14.
Body weight:
Day: 0 7 14
males: 2.7 2.8 3.1
females: 2.6 2.7 2.9
Gross pathology:
no systemic signs of toxicity except signs of toxicity of the integumentary system: Erythema and discoloration of the back

Applicant's summary and conclusion

Conclusions:
The study is well performed and gives following results for the Endpoint:
No mortality occured at a dose of 2000 mg/kg bw. LD50 > 2000 mg/kg bw