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Toxicological information

Skin irritation / corrosion

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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 type of salification, i.e. potassium and sodium salt 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 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.