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Toxicological information

Skin irritation / corrosion

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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:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
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 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.