Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP laboratory study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA/CPSC Design, 16 CR 1500

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Branched CaDDBS

IUPAC Name:

Branched CaDDBS

Constituent 2

Reference substance name:

Ninate 401-A

IUPAC Name:

Ninate 401-A

Details on test material:

yellow liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbitry, Gary, Indiana
- Age at study initiation: 8 to 10 weeks old
- Weight at study initiation: Not stated
- Housing: Individually housed in stainless steel cages in a temperature, humidity and light controlled room in accordance with the recommendations contained in the National Academy Press 1996 "Guide for the Care and Use of Laboratory Animals."
- Diet (e.g. ad libitum): ad libitum Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

Observed at 4.5, 24, 72, 168 and 336 hours after application

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 1 inch square for each site
- Type of wrap if used: two layer gauze patch secured with non-irritating porous adhesive tape and then the entire site was covered with a 4 mil plastic and secured with more adhesive tape.

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

SCORING SYSTEM: Draize Scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 4.5 hours

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 4.5 hours

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 4.5 hours

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 4.5 hours

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 4.5 hours

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 4.5 hours

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 7

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 8

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 9

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 10

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 11

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 12

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 13

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 14

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 15

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 16

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 17

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 18

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 19

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

7 d

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 20

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

7 d

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 21

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

7 d

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 22

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

7 d

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 23

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

7 d

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 24

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

7 d

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 25

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

14 d

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 26

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

14 d

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 27

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

14 d

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 28

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

14 d

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 29

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

14 d

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 30

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

14 d

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 31

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 4.5 hours

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 32

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 4.5 hours

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 33

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 4.5 hours

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 34

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 4.5 hours

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 35

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 4.5 hours

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 36

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 4.5 hours

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 37

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 38

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 39

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 40

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 41

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 42

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 43

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 44

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 45

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 46

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 47

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 48

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 49

Irritation parameter:

edema score

Basis:

animal #1

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 50

Irritation parameter:

edema score

Basis:

animal #2

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 51

Irritation parameter:

edema score

Basis:

animal #3

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 52

Irritation parameter:

edema score

Basis:

animal #1

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 53

Irritation parameter:

edema score

Basis:

animal #2

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 54

Irritation parameter:

edema score

Basis:

animal #3

Time point:

7 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 55

Irritation parameter:

edema score

Basis:

animal #1

Time point:

14 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 56

Irritation parameter:

edema score

Basis:

animal #2

Time point:

14 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 57

Irritation parameter:

edema score

Basis:

animal #3

Time point:

14 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Unabraded

Results 58

Irritation parameter:

edema score

Basis:

animal #1

Time point:

14 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 59

Irritation parameter:

edema score

Basis:

animal #2

Time point:

14 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 60

Irritation parameter:

edema score

Basis:

animal #3

Time point:

14 d

Score:

1

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Abraded

Results 61

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

other: 48 h observations were not recorded

Results 62

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

other: 48 h observations were not recorded

Results 63

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

other: 48 h observations were not recorded

Results 64

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

other: 48 h observations were not recorded

Results 65

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

other: 48 h observations were not recorded

Results 66

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

other: 48 h observations were not recorded

Irritant / corrosive response data:

See table

Any other information on results incl. tables

Primary Dermal Irritation

Rabbit Number	4.5 hours
	Unabraded		Abraded
	ER	ED	ER	ED
283	4	2	4	2
284	4	3	4	3
285	3	2	4	2
Average	3.7	2.3	4.0	2.3
Rabbit Number	24 hours
	Unabraded		Abraded
	ER	ED	ER	ED
283	4	3	4	3
284	4	3	4	3
285	3	3	3	3
Average	3.7	3.0	3.7	3.0
Rabbit Number	72 hours
	Unabraded		Abraded
	ER	ED	ER	ED
283	4	2	4	2
284	4	1	4	1
285	4	1	4	1
Average	4.0	1.3	4.0	1.3
Rabbit Number	7 days
	Unabraded		Abraded
	ER	ED	ER	ED
283	3	1	3	1
284	4	1	4	1
285	4	1	4	1
Average	3.7	1.0	3.7	1.0
Rabbit Number	14 days
	Unabraded		Abraded
	ER	ED	ER	ED
283	3	1	3	1
284	3	1	3	1
285	4	1	4	1
Average	3.3	1.0	3.3	1.0

ER = Erythema; ED = Edema

24 hour score: 13.4

72 hour score: 10.6

Total score: 24.0

Primary dermal irritation score: 6.0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

The test substance is a primary dermal irritant.

Executive summary:

The test substance, Ninate 401 -A, was tested for primary dermal irritation in accordance with FHSA/CPSC Guidelines. The sample was applied at a dose of 0.5 mL per site to unabraded and abraded skin sites in a clipped area of each of three albino rabbits. The test sites were occluded and the test material remained on the skin for a 4 hour contact period. Application sites were graded using the Draize scoring system at 4.5, 24, 72, 168 and 336 hours after application. The primary dermal irritation score was 6.0, indicating that the substance is a primary dermal irritant.