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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1993-06-22 to 1993-06-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD test guideline 404 (Acute Dermal Irritation / Corrosion) and in complaince with Good Laboratory Practice Regulations as described by the OECD annex 2 C(81)30.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Room temperature is 21°C to 25°C, Humidity is 54%to 89%, Dose is (0.20 g) 200mg
Principles of method if other than guideline:
None
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Sodium Cumenesulphonic acid
IUPAC Name:
Sodium Cumenesulphonic acid
Details on test material:
- Name of test material (as cited in study report): Low Completion Index SE2SI (SEC-Base) (Sodium cumenesulphonate)
- Molecular formula (if other than submission substance): C9H12O3S
- Molecular weight (if other than submission substance): na
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: See below
- Impurities (identity and concentrations): See below
- Composition of test material, percentage of components: See below
- Isomers composition: See below
- Purity test date: See below
- Lot/batch No.: See below
- Expiration date of the lot/batch: See below
- Stability under test conditions: See below
- Storage condition of test material: Room temperature in a dessicator
- Other:See below

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry,Loudonville,Ohio
- Age at study initiation: na
- Weight at study initiation: 2.1 to 2.5 grams
- Housing: Individually housed in stainless steel cages
- Diet (e.g. ad libitum): Purina Certified Rabbit chow # 5322
- Water (e.g. ad libitum):Water purified by reverse osmosis -ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 25°C
- Humidity (%): 54% to 89%
- Air changes (per hr): na
- Photoperiod (hrs dark / hrs light): 12 hour dark and 12 hour light


IN-LIFE DATES: From: 1993-06-22 To: 1993-06-25

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200mg of test article
- Concentration (if solution): na


VEHICLE
- Amount(s) applied (volume or weight with unit):na
- Concentration (if solution):na
- Lot/batch no. (if required): na
- Purity:na
Duration of treatment / exposure:
Three adult New Zealand white rabbits were treated with 200 mg of the test substance on to the intact skin sites with 25 mm Hilltop chamber with cotton pad.After 4 hours exposure period, the expendover tape were removeed and the treated sites were observed for erythema and edema at 4hr, 24 hour 48 hour and 72 hours.
Observation period:
41/2 hour,24 hour, 48 hour and 72 hours.
Number of animals:
Three New Zealand white rabbits.
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk of each animal
- % coverage: na
- Type of wrap if used: Wrappings of Expandover and Athletic tape was used.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): na
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Erythema and Eschar formation:
0=no erythema, 1= very slight erythema, 2= slight erythema, 3=moderate to severe erythema, 4=severe erytheama, 4/4 highest possible erythema score
Edema formation:
0=no edema, 1=very slight edema, 2=slight edema, 3=moderate to severe edema, 4=severe edema,4/4 =highest possible edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hr
Score:
1.33
Max. score:
1.33
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
erythema score
Basis:
mean
Remarks:
2 rabbits with grade 1 & 1 with grade 1
Time point:
other: 4 hr
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin iste
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 3 rabbits with grade 1
Time point:
other: 4 hr
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24
Score:
1.66
Max. score:
1.66
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 rabbit with grade 1 & 2 with grade 2
Time point:
other: 24 hr
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 3 rabbits with grade 0
Time point:
other: 24 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hr
Score:
0.66
Max. score:
0.66
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 rabbit with grade 0 & 2 with grade 1
Time point:
other: 48 hr
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
edema score
Basis:
mean
Remarks:
all 3 rabbits with grade 0
Time point:
other: 48 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Intact skin site
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Intact skin site
Irritant / corrosive response data:
PII 1.33 at 4 hours at erythema and 1.0 at edema intact skin site
PII 1.66 at 24 hours at erythema and 0.0 at edema intact skin site
PII 0.66 at 48 hours at erythema and 0.0 at edema intact skin site
PII 0.0 at 72 hours at erythema and 0.0 at edema intact skin site

Other effects:
None

Any other information on results incl. tables

 Animal number       Degreeof erythema after (Observation ime)      Degreeof edema after (Observation ime)       Mean >=1.5 <2.3 ?   
   24 hr  48 hr  72 hr  24 hr  48 hr  72 hr  Erythema Edema  

 7803

 1  2  2  0  0  0 YES  NO
         Mean= 1.66         Mean= 0.00       
 7788  0  1  1  0  0  0  NO NO    
         Mean=0.66         Mean= 0.00       
 7789  0  0  0  0  0  0 NO  NO    
         Mean= 0.00         Mean= 0.00       

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance is a mild skin irritant.
Executive summary:

Three New Zealand white rabbits were treated with 200 mg of test substance occlusively, produced slight erythema of all 3 three animals at 4.5 hours reading. Similar observations were made at 24hr, 48 hr and 72 hours. The skin responses completely resolved by 72 hours reading. Based on the observations, the test substance is a mildly irritating to the dermal tissue of the rabbit.