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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 March to 26 March 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study undertaken to internationally accepted guidelines but before the implementation of GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41 Method of testing primary irritant substances
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
S-205
IUPAC Name:
S-205
Details on test material:
- Name of test material (as cited in study report): S-205
- Physical state: white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: reputable breeders
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.7 to 3.2 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to laboratory animal diet Grain Harvester 474 Special Rabbit Pellets
- Water (e.g. ad libitum): free access to tap water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12hrs dark / 12hrs light

IN-LIFE DATES: From: 23 March 1982 To: 26 March 1982

Test system

Type of coverage:
occlusive
Preparation of test site:
other: 10 cm square shaved then 2.5 cm square on the right side of the spine was abraded
Vehicle:
water
Remarks:
to moisten the substance
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): 1g/mL

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5mL of water
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square of abraded skin and 2.5 cm square of intact skin
- Type of wrap if used: gauze pads covered by "Elastoplast" elastic adhesive dressing backed with "Sleek" plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment sites were wiped to remove any residual test substance
- Time after start of exposure: 24 h

SCORING SYSTEM: Scoring was performed at 24 h and 72 h

Erythema and eschar formation:
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erytryema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema formation:
0 No oedema
1 Very slight oedema (barely perceptible) 1
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (raised approximately 1 mm)
4 Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No dermal reactions were seen in any of the rabbits after 24 h exposure to S-205 during the 72 h observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
S-205 is not considered to be an irritant to rabbit skin