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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
Study period:
2009-10-05 to 2009-11-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkez u. 90;
- Age at study initiation: 8 weeks;
- Weight at study initiation: males: 244 - 267 g; females. 22 - 233 g;
- Fasting period before study: not stated;
- Housing: during acclimatisation: 3 animals/sex/cage; during the study: animals were housed individually in type-II polypropylene/polycarbonate cages;
- Diet: ssniff SM/ R/m-Z + H complete diet; producer: ssniff Spezialdiäten GmbH, D-59494 Soest, Germany; ad libitum;
- Water: tap water from watering bottles; ad libitum;
- Acclimation period: 9 days;


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


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The back of animals was shaven (approximately 10 % area of the total body surface) 24 hours prior to the treatment. The test item was applied in a
single dose uniformly at least 10 % area of the total body surface throughout a 24-hour exposure period. The test item was moistened sufficiently with water to ensure good contact with the skin. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi-occlusive plastic wrap for 24 hours.
At the end of the exposure period, residual test item was removed, using body temperature water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males; 5 females
Control animals:
no
Details on study design:
The test for acute dermal toxicity was performed in the rats.
In the assessment and evaluation of the toxic characteristic of a substance, determination of acute dermal toxicity is useful where exposure by the
dermal route is likely. It provides information on health hazards likely to arise from a short term exposure by the dermal route. Data from an acute dermal toxicity study may serve as a basis for classification and labelling.
The objective of the study was to reveal, that the dermal LD50 of the test item potassium cyanate is higher than 2000 mg/kg bw after a single 24-hour dermal treatment in rats, therefore a limit test was carried out. No valid in vitro method is available for assessing acute dermal toxicity.


Statistics:
LD50 determination

Results and discussion

Preliminary study:
none
Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred after the 24-hour dermal exposure to potassium cyanate in Crl:(WI)BR male and female rats during the study.
Clinical signs:
No behavioural changes or general systemic toxic signs were noted during the study. Similarly, no any local symptoms (dermal irritation) were observed on the treated skin of animals as redness and oedema.
Body weight:
The mean body weight and the body weight gain of animals were in the normal range during the two weeks observation period, similar to the
expected values in untreated animals of the same age and strain.
Gross pathology:
No macroscopic alterations due to the effects of the test item were found.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the experimental conditions, the acute dermal LD50 value of the test item potassium cyanate proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.


Executive summary:

An acute dermal toxicity study was performed with test item potassium cyanate in Crl:(WI)BR rats, in compliance with OECD Guideline No. 402 and Commission Regulation (EC) 440/2008 of 30 May 2008 B.3.

A limit test was carried out. A single group of male and female animals (n=5 animals/sex) was exposed to potassium cyanate at 2000 mg/kg bw by dermal route.

The test item was applied in original form and left in contact with the skin for 24 hours, followed by a 14-day observation period.

No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no general toxic signs were noted during the study.

The test item did not cause any dermal irritation symptoms.

The body weight development was undisturbed both in male and female animals.

No macroscopic alterations of organs and tissues referred to the toxic effect of the test item were seen during the necropsy.

 

Under the experimental conditions, the acute dermal LD50 value of the test item potassium cyanate proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.