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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Between 6 October 1999 and 14 October 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted to guidelines and GLP and reported fully.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Agricultural Chemicals Laws & Regulations Testing Guidelines for Toxicology Studies (MAFF) [59 NohSan No. 4200 (1985)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
EC Number:
274-263-7
EC Name:
Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts
Cas Number:
70024-69-0
IUPAC Name:
sodium 4-icosylbenzenesulfonate
Test material form:
other: liquid
Details on test material:
the test substance was a similar material to the registered substance (aryl alkyl sulphonate)
- Storage condition of test material: Ambient
- Other: Dark brown viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products
- Age at study initiation: Young adult
- Weight at study initiation: 2071 to 2480 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): LabDiet 150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C (68.3 - 68.8 °F)
- Humidity (%): 30.2-55%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24h, 48h, 72h and 8 days
Number of animals:
3/sex
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Gauze binder

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped with paper towels moistened with deionised water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
erythema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
edema score
Remarks:
Animal 1
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Remarks:
Animal 2
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 3
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Remarks:
Animal 4
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
Animal 5
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Remarks:
Animal 6
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mean score calculated by average of results at 24h, 48h and 72h for each animal.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Oedema

Max. score: 2

Max. score: 1

24 h

1/1/1/2/1/1

1/0/1/0/1/0

48 h

1/1/1/2/1/1

1/0/0/0/0/0

72h

1/1/1/1/1/1

1/0/0/0/0/0

Average 24h, 48h, 72h

 1.2/1.2/1

 0.5/0.2/0.2

 Reversibility*)

 c

 c

 Average time (unit) for reversion

 7 days

 48h

 

*) Reversibility: c. = completely reversible;= not completely reversible; n. = not reversible

 

Mortality: There were no deaths during the study.

 

Dermal Observations (Table 2):

Very slight to slight erythema and desquamation were noted for all animals. Very slight edema was noted for three animals. All dermal irritation completely subsided

by day 8.

The Primary Irritation Index (PII) was calculated to be 1.4, using the 24-, 48- and 72 -hour observations. The test article received a descriptive rating classification of slightly irritating.

TABLE 2

PROJECT NO.WIL-168169

ACUTE DERMAL IRRITATION STUDY IN ALBINO RABBITS                                              
INDIVIDUAL DERMAL SCORES

SITE A: 0.5 ML/SITE

 

ERYTHEMA

EDEMA

ANIMAL

SEX

SITE

1H

24H

48H

72H

4D

5D

6D

7D

8D

SITE

1H

24H

48H

72H

4D

5D

60

7D

8D

29982

M

A

1s

1s

1

1

1

1

0d

-

-

A

0

1

1

1

0

0

0

-

-

29983

M

A

0s

1s

1

1

1

1

0d

-

-

A

0

0

0

0

0

0

0

-

-

29984

M

A

0s

1s

1

1d

1d

1d

1d

1d

0

A

0

1

0

0

0

0

0

0

0

29993

F

A

1

2

2

1d

1d

1d

1d

0d

-

A

0

0

0

0

0

0

0

0

-

29994

F

A

1

1

1

1d

1d

0d

-

-

-

A

1

1

0

0

0

0

-

-

-

29995

F

A

1

1

1

1

1

1d

0d

-

-

A

0

0

0

0

0

0

0

-

-

 

 

TOTAL

4

7

7

6

6

5

2

1

0

TOTAL

1

3

1

1

0

0

0

0

0

PII calculated using test periods: 24h, 48h, 72 h

Primary Irritaton Index (PII) = [(7+7+6)/18] + [(3+1+1)/18]

(PII) = [20/18] + [5/18]

(PII) = 1.1 + 0.3

PII  = 1.4 = SLIGHTLY IRRITATING

PII calculated using test periods: 24h, 72 h

Primary Irritaton Index (PII) = [(7+6)/12] + [(3+1)/12]

(PII) = [13/12] + [4/12]

(PII) = 1.1 + 0.3

PII  = 1.4 = SLIGHTLY IRRITATING

 

H = HOURS     

 D = DAYS 

F = FEMALE

M = MALE 

d = DESQUAMATION  

s = DOSE SITE STAINED YELLOW

 - = DERMAL IRRITATION PREVIOUSLY SUBSIDED; ANIMAL TERMINED FROM STUDY

 

Body Weights (Table 3):

There were no remarkable body weight changes during the study.

Table 3

Acute Dermal Irritation Study in Albino Rabbits

Individual Body Weights (Grams)

Initiation

Termination

Group

Number

Sex

(Day 0)

(Interval)

0.5 ml/site

29982

M

2480

2693 (Day 6)

29983

M

2218

2320 (Day 6)

29984

M

2329

2504 (Day 8)

29993

F

2071

2294 (Day 7)

29994

F

2213

2507 (Day 5)

29995

F

2311

2596 (Day 6)

M = Male

F = Female

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Mean scores for each animal at 24h, 48h and 72 h for erythema and oedema, respectively, were 0. Therefore, this substance is not irritating to skin under the conditions of this test.
Executive summary:

The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits. There was one group of six young adult albino rabbits that received a single, four-hour, semioccluded exposure. Each 0.5 ml dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed. Application sites were evaluated in accordance with the method of Draize at approximately 30-60 minutes and 24,48 and 72 hours after patch removal and daily through day 8, if irritation persisted. Very slight to slight erythema and desquamation were noted for all animals. Very slight edema was noted for three animals. All dermal irritation completely subsided by day 8. The Primary Irritation Index (PII) was calculated to be 1.4, using the 24-, 48- and 72 -hour observations. The calcium sulfonate read across substance (CAS 70024 -69 -0) received a descriptive rating classification of slightly irritating. The Primary Irritation Index (PII) was 1.4 (24, 48 and 72 hours) and 1.4 (24 and 72 hours). This is however, not considered to be irritating taking into account the classification criteria for skin irritation by the european global harmonised system (a dermal irritant is a substance which causes a primary irritation index of >2.3 < 4).