Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
06 August 2003 - 20 August 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed according to internationally accepted guidelines and acocrding to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (.JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: KSCN (potassium thiocyanate)
Structure: K+ N::::::: C-S
Molecular formula: KSCN
Molecular weight: 97.2
CAS Number: 333-20-0
Description: White crystals
Batch: 97L51-SCN
Purity: 99.0%
Test substance storage: In refrigerator in the dark (in exicator)
Stability under storage conditions: stable
Expiry date: 01 November 2003

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: ±10 weeks
- Weight at study initiation: males 340 g, females 238 g
- Fasting period before study: not applicable
- Housing: Individually housed in labelled Macrolon cages (type III, height 15 cm.) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
- Diet (e.g. ad libitum): Free access to standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany). Certificates of analysis were examined and then retained in the NOTOX archives.
- Water (e.g. ad libitum): Free access to tap·water. Certificates of quarterly analysis were examined and then retained in the NOTOX archives.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19.1-24.5
- Humidity (%): 44-79
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 06 August 2003 - 20 August 2003

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: The formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after dressings were removed and the skin cleaned of residual test substance using water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 ml/kg) body weight
- Concentration (if solution): variable
- Constant volume or concentration used: constant volume
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): variable
- Concentration (if solution): variable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
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:
Mortality/Viability: Twice daily

Body weights: Days 1 (pre-administration), 8 and 15

Clinical signs:
At periodic intervals on the day of dosing (day 1) and once daily
thereafter, until day 15. The time of onset, degree and duration
were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).

Necropsy
At the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
Statistics:
No statistical analysis was 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 mortality occurred.
Clinical signs:
Chromodacryorrhoea was noted in all animals. All animals had recovered from the symptoms between days 2 and 3.

Erythema, necrosis, scales, scabs were seen in the treated skin-area of the animals during the observation period.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The dermal LD50 value of KSCN in Wistar rats was established to exceed 2000 mg/kg body weight. No significant signs of toxicity were observed at this dose level.
Executive summary:

Assessment of acute dermal toxicity with KSCN (POTASSIUM THIOCYANATE) in the rat. The study was carried out based on the guidelines described in: Environmental Protection Agency (EPA): Health Effects Test Guidelines OPPTS 870.1200. "Acute Dermal Toxicity", EC Commission Directive 92/69/EEC, Part B.3, "Acute Toxicity-Dermal", OECD No.402, "Acute Dermal Toxicity" and JMAFF: Japanese Test Guidelines.

KSCN (POTASSIUM THIOCYANATE) was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred. Chromodacryorrhoea was noted in all animals. All animals had recovered from the symptoms between days 2 and 3.

Erythema, necrosis, scales, scabs were seen in the treated skin-area of the animals during the observation period. The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals.

The dermal LD50 value of KSCN (POTASSIUM THIOCYANATE) in Wistar rats was established to exceed 2000 mg/kg body weight.