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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:
08 - 15 Mar 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-biphenylate
EC Number:
205-055-6
EC Name:
Sodium 2-biphenylate
Cas Number:
132-27-4
Molecular formula:
C12H9NaO
IUPAC Name:
sodium 2-phenylphenolate
Test material form:
solid: particulate/powder
Details on test material:
Batch No.: 80/07319

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd. (breeder)
- Weight at study initiation: 3.1, 3.2 and 3.3 kg, respectively
- Housing: The rabbits were individually housed in single cages (wire cages type III-high). Below the cages excrement trays with low-dust wood granulate type S 8/15 (Ssniff, Soest, Germany) were located.
- Diet: Standard diet "Ssniff K 4" (supplied by Versuchstierdiäten GmbH, Soest, Germany), approximately 100 - 120 g per animal and day
- Water: Tap water, ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): Approximately 50
- Air changes (per hr): Approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Mar 1988 To: 15 Mar 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: The test substance was made into a paste with water.
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: Approximately 6 cm² on the dorsal area of the trunk
- Type of wrap: The treated skin was covered with Hansamed plaster and fixed with an elastic adhesive bandage (Fixomull-Strech adhesive non-woven material, Beiersdorf No. 1524).

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 7 days

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritant / corrosive response data:
All 3 animals showed edema and erythema scores of 3 at the 1-h reading time point, which resulted in an edema and erythema score of 4 at the 24-, 48- and 72-h and at the 7-day reading time point. In addition, the skin of all 3 rabbits displayed necrotic changes after 24 h.

Any other information on results incl. tables

Table 1: Summary of results

Observation time Rabbit no.
1 2 3
Erythema Edema Erythema Edema Erythema Edema
1 h 3 3 3 3 3 3
24 h 4 4 4 4 4 4
48 h 4 4 4 4 4 4
72 h 4 4 4 4 4 4
Mean value 24 + 48 + 72 h 4,00 4,00 4,00 4,00 4,00 4,00

Applicant's summary and conclusion

Interpretation of results:
other: Skin Corr 1A, H314 according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: Skin Corr 1A, H314