Registration Dossier
Registration Dossier
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EC number: 214-183-1 | CAS number: 1111-67-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Test commenced on 31 May 1988 and completed on 04 June 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted to internationally recognised guidelines but not to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- no
Test material
- Reference substance name:
- Copper thiocyanate
- EC Number:
- 214-183-1
- EC Name:
- Copper thiocyanate
- Cas Number:
- 1111-67-7
- Molecular formula:
- CHNS.Cu
- IUPAC Name:
- copper thiocyanate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Substance type: Powder
- Analytical purity: Not reported
- Lot/batch No.: 88/3/1
- Stability under test conditions: Not reported
- Storage condition of test material: Dark under ambient conditions
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire, UK.
- Age at study initiation: Young adult
- Weight at study initiation: Not reported.
- Housing: Housed individually in aluminium cages with grid floors beneath which were peat moss filled trays.
- Diet (e.g. ad libitum): Rabbit Diet, supplied by Special Diet Services, 1 Stepfield, Witham, Essex, CM8 3 AB), allowed ad libitum.
- Water (e.g. ad libitum): Tap water, allowed ad libitum.
- Acclimation period: 7 days before test commencement
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean max and min temperatures were 19°C and 17°C.
- Humidity (%): Mean relative humidity was 58%.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): A 12h light/dark cycle was in operation (light hours 0700-1900h).
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- The hair was clipped from the dorsal area of the trunk of each rabbit approx. 24 h before treatment. Care was taken to avoid abrading the skin.
- Vehicle:
- water
- Remarks:
- Distilled water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500mg test material moistened with water.
VEHICLE
- Amount applied: Not reported.
- Concentration in vehicle: Not reported. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were assessed 1, 24, 48 and 72 h after patch removal.
- Number of animals:
- 6 animals - 3 male and 3 female (nulliparous and non-pregnant)
- Details on study design:
- TEST SITE
- Area of exposure: The test material was applied to intact skin on each rabbit under a 2.5 cm x 2.5 cm patch of gauze.
- % coverage: Not reported
- Type of wrap if used: The patch of gauze was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4hr period of exposure, the patch was removed and the skin wiped with damp tissues to remove surplus test material without altering the existing response or the integrity of the epidermis.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Skin reactions were assessed 1, 24, 48 and 72 h after patch removal using the scoring system noted in the section "Any other information on materials and methods incl. tables"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: All animals (male and female)
- Time point:
- other: 1 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- edema score
- Basis:
- other: All animals (male and female)
- Time point:
- other: 1 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- erythema score
- Basis:
- other: All animals (male and female)
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- edema score
- Basis:
- other: All animals (male and female)
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- erythema score
- Basis:
- other: All animals (male and female)
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- edema score
- Basis:
- other: All animals (male and female)
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- erythema score
- Basis:
- other: All animals (male and female)
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritation parameter:
- edema score
- Basis:
- other: All animals (male and female)
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- other: Not relevant. No skin irritation seen.
- Irritant / corrosive response data:
- Details of reaction scores are given in the "illustration" section below. No irritation was noted at any time during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Following a 4 h semi-occlusive exposure to cuprous thiocyanate, it is concluded that this material is non-irritant to rabbit skin.
- Executive summary:
The execution of this type of short-term study is not individually inspected by the Quality Assurance Department. The processes involved are inspected at intervals according to a pre-determined schedule.
The report has been audited by IRI Quality Assurance Personnel according to the appropriate Standard Operating Procedures and is considered to describe the methods and procedure used in the study. The reported results accurately reflect the original data of the study.
Following a 4 h semi-occlusive exposure to cuprous thiocyanate, it is concluded that this material is non-irritant to rabbit skin.
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