Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Study period:
Aug. 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
yes
Remarks:
Temperature range exceeded OECD guidelines by 1° C. Artificial lighting sequence is 10 hours dark, 14 hours light. Occulisive instead of semi-occlusive patch.
Principles of method if other than guideline:
- Principle of test: determine irritation and corrosion potential of the test item.
- Short description of test conditions: a single 4-hour application of 0.5 g of test item is applied to the clipped, dorsal area of 3 rabbits. Erythema and oedema effects are monitored at 1, 24, 48 and 72 hours after the removal of the test item. The sum of 24 and 72 hour Draize values for erythema and oedema (12 scores) is divided by 6 to give the Primary Irritation Index.
- Parameters analysed / observed: erythema formation, oedema formation, corrosive events, discolouration.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
-
EC Number:
400-320-4
EC Name:
-
Cas Number:
94933-05-8
Molecular formula:
not applicable
IUPAC Name:
Reaction products of diazotised anthranilic acid coupled with resorcinol and diazotised 5-aminonaphthalene-1-sulphonic acid, metallised with Chromium (III) basic sulphate, sodium salts
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldborough, Hull, HU11 4QE, England
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 4.30 to 4.55 kg
- Gender: female; nulliparous and non-pregnant
- Housing: individually in grid floor cages
- Diet: ad libitum; Standard Rabbit Diet, Special Diets Services Ltd. (Stepfield, Witham, Essex, England)
- Water: ad libitum (analytical test report demonstrates suitability)
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 24 °C
- Humidity: 40 to 47 %
- Air changes per hour: not specified
- Photoperiod (hrs dark / hrs light): 10/14

IDENTIFICATION:
- individually, using a system of indelible ink marking on the inner pinnae (Inscribe 700, Inscribe Ltd., Alton, Hampshire, England)

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
moistened with water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g test item moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on dorsal area
- % coverage: unspecified
- Type of wrap if used: occluded gauze patch secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Ltd., Welwyn Garden City, Herts, England)

REMOVAL OF TEST SUBSTANCE
- Washing: wiped clean with disposable paper towel
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after removal of test item

SCORING SYSTEM: Primary Irritation Index
- Draize scores at 24 and 72 hours after test item removal for each rabbit were added together and divided by 6 for both erythema and for oedema formation.

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

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

- Primary Irritation Index was calculated using the following values:

Primary Irritation Index Classification of Irritancy
0 non-irritating
0-2 slightly irritating
2-5 moderately irritating
over 5 severely irritating

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No adverse skin reactions, corrosive effects or clinical symptoms were observed.
Other effects:
COLOURATION
The treated sites were stained brown by the test item at the following time points:
Test animal #1: 1, 24 and 48 hours
Test animal #2: 1 and 24 hours
Test animal #3: 1, 24, 48 and 72 hours

Any other information on results incl. tables

Table 1: Individual skin irritation reactions.

Animal number and gender Body weight Observation time after exposure period Erythema Oedema
5614F 4.55 1 hour 0s 0
24 hours 0s 0
48 hours 0s 0
72 hours 0 0
5615F 4.30 1 hour 0s 0
24 hours 0s 0
48 hours 0 0
72 hours 0 0
5616F 4.54 1 hour 0s 0
24 hours 0s 0
48 hours 0s 0
72 hours 0s 0
Total*:   0 0
Primary irritation index:   0/6 0

* total = sum of 24 and 72 hour values

s = treatment area stained brown by test item

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The test item was not found to be a Skin Irritant or a Skin Corrosive.
Executive summary:

The skin irritation potential of the test item was evaluated in an experimental procedure comparable to OECD Guideline 404 (1981). 0.5 g of undiluted, solid test item was applied to the clipped, dorsal area of 3 female New Zealand albino rabbits and secured for a duration of 4 hours with an occlusive dressing. The surrounding skin of the test animal was considered a negative control. Animals were then monitored for erythema (score out of 4), oedema (score out of 4), corrosion, clinical symptoms and discolouration at 1, 24, 48 and 72 hours after removal of the test item and dressing. 

No clinical symptoms, irritation or corrosion was observed during the test period, so the study was terminated at 72 hours. No erythema or oedema was observed during the study period, and irritation scores (mean 24, 48 and 72 hours) were 0 for both erythema and oedema in all three animals. In the area of application, slight brown staining of the treated skin by pigment or colouring by the test item was observed at 48, 24 and 72 hours in test subjects #1, #2 and #3, respectively. 

Categories Display