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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:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Necropsy revealed a significant inhalative coexposure causing severe, extensive hemorrhages of the lung in many animals. Inhalative coexposure may have caused additional deaths.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SPF breed: Hagemann, Extertal, Germany
- Weight at study initiation: males: 224 g; females: 183 g
- Fasting period before study:
- Diet: ad libitum; MRH concentrated feed of H . Eggersmann, Rinteln/Weser, Germany,
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 13 .3 cm2; to the clipped skin of the back and flank
- Type of wrap if used: The treated area of skin was then covered with an inert foil, which was secured in position with adhesive tape .

REMOVAL OF TEST SUBSTANCE
- Washing with warm water and dried with cellulose
- Time after start of exposure: after 24 h
Doses:
2000; 1000 and 640 mg/kg .
No. of animals per sex per dose:
5 (640 and 2000 mg/kg); 6 (1000 mg/kg)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
894 mg/kg bw
95% CL:
693 - 1 161
Mortality:
After 14 days: 649 mg/kg: females 0/5, males 2/5; 1000 mg/kg: females 5/6, males 2/6; 2000 mg/kg: females 5/5, males 5/5
Clinical signs:
Dyspnea, apathy, staggering, cyanosis, tonic convulsions, spastic gait and piloerection
Signs of local irritation : After 24 hours, clear signs of primary irritation ; after 4 days, leathery necroses.
Body weight:
Mean body weight development of the surviving animals was positive.
Gross pathology:
Animals that died: Heart: acute dilatation on the right side; acute passive hyperemia;
lungs: severe, extensive hemorrhages (wet and sarcoid areas) in some cases
Sacrificed animals: Organ : no abnormalities detected

Any other information on results incl. tables

The product was applied once for 24 hours to the clipped skin of the back and flank (area of 13.3 cm2) unchanged in doses of 2,000 ; 1,000 and 640 mg/kg .The median lethal dose ( LD50) for males and females after 14 days was: 894 mg/kg (693 -1,161 mg/kg )

Applicant's summary and conclusion