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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Source study has reliability 2. The use of a read across approach is considered as acceptable, since target and read across substance differ only in the degree of salification, i.e. monosodium vs. disodium salt.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01
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
- Body weight: 2.2 - 2.3 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Humidity: 40 - 60 %
- Photoperiod: 12 h dark / 12 h light

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- Type of wrap if used: gauze fixed by elastic, air-permeable adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48, 72 h up to 7 d

SCORING SYSTEM:
Erythema - redness / scabbing
0 no redness
1 slight, barely perceptible redness
2 well noticeable redness
3 moderate to severe redness
4 deep redness to slight scabbing (changes to id the depth of the skin)

Oedema - swelling
0 no swelling
1 very slight, barely perceptible swelling
2 slight swelling (margins well defined)
3 moderate swelling (meander approx. 1 mm raised)
4 severe swelling (margins greater than 1 mm raised, extension via exposure site)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit skin.
Executive summary:

Method

Test substance was applied on skin of 3 male rabbits according to OECD guideline 404. Test substance was removed by rinsing with water 4 hours after application. Observations for erythema and oedema were done at 1, 24, 48 and 72 h up to 7 days after substance removal.

Results

No signs of irritation in terms of erythema and oedema were noted.