Sodium thiocyanate

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Test guideline 4

Qualifier:

according to guideline

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

Test material information

Constituent 1

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 or test system 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:

other: 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.

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 (POTASSIUM THIOCYANATE) in Wistar rats was established to exceed 2000 mg/kg body weight. No significant signs of toxicity were observed at this dose level and therefore the test substance is not classified for acute dermal toxicicty.

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 NoA02, "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 LDso value of KSCN (POTASSIUM THIOCYANATE) in Wistar rats was established

to exceed 2000 mg/kg body weight.