Benzenesulfonic acid, 4-(branched alkyl derivs.) and benzenesulfonic acid, 4-(linear alkyl dervis.), calcium salts

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 4

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

Test material information

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

Irritation parameter:

edema score

Remarks:

Animal 2

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 9

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

Results 10

Irritation parameter:

edema score

Remarks:

Animal 4

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Results 11

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

Results 12

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).