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Diss Factsheets

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

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium cyanate
EC Number:
209-676-3
EC Name:
Potassium cyanate
Cas Number:
590-28-3
Molecular formula:
KOCN
IUPAC Name:
potassium cyanate
Details on test material:
- Chemical name: potassium cyanate
- Analytical purity of the test material: 98.2 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system 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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 10 % area of the total body surface
- % coverage: 10%
- Type of wrap if used: 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.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h

TEST MATERIAL
- For solids, paste formed: yes
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:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
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:
other: 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.
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:
GHS criteria not met
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.