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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 402 (1987)
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Dastib 845
IUPAC Name:
Dastib 845

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Acclimatization period: 7 days
kept individually
temperature: 22±2°C
humidity: 50-70%
comercial diet
water: ad libitum

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
24 h before application hair was cut down from 10% of total surface area covered by non irritating tape for 24 h and then removed with olive oil observation period: 14 days.
Duration of exposure:
24 h
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 males
5 females
Control animals:
no
Statistics:
Student T-Test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Nach Ablauf des Ausstellungszeitraums wurden keine systemischen Toxizitatserscheinungen festgestellt. Auch einen oder zwei Tage spater wurden keine Toxizitatserscheinungen beobachtet.

Following the end of the exhibition period, no
systemic toxicity effect observed . Also
one or two days later were not toxicity effect observed.
Gross pathology:
Effects on organs: Die Nekrosebefunde und histopathologischen Veranderungen waren negativ.
The necrosis bias results and histopathological changes
were negative.
Other findings:
Signs of toxicity (local):
Nach Ablauf des Ausstellungszeitraums von 24 Stunden wurden
keine ortlichen Toxizitatserscheinungen festgestellt. Auch
einen oder zwei Tage spater wurden keine
Toxizitatserscheinungen beobachtet.
Following the end of the exhibition period of 24 hours
no local toxicity adverse effect was identified. Also
one or two days later were not
adverse effects observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU