[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29/10/1980 to 1/11/1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

This primary dermal irritation study was conducted prior to the adoption of OECD Guideline 404 (original adopted in 1981). However, the study was conducted in accordance with the test facility protocol and US FHSA guidelines available at the time. Study methods and results are well documented in the study report and summarised here.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins

Molecular formula:

Cannot be adequately determined for this UVCB substance

IUPAC Name:

Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins

Test material form:

liquid

Details on test material:

Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. E-050 is described in the study reports as a thick, brown oily liquid.

Specific details on test material used for the study:

Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. Described in the study reports as a thick, brown oily liquid.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: B&D Commercial Rabbitry, Malvern, Arkansas
- Age at study initiation: At least 8 weeks old
- Weight at study initiation: 2507-2866 g
- Housing: Individually housed in stainless steel cages, which are elevated above the droppings, in an environmentally controlled room. Rooms and cages maintained in accordance with the standards of the American Association for Accredication of Laboratory Animal Care (AAALAC).
- Diet: Wayne Feeds Rabbit Ration available ad libitum
- Water: Tap water available ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: To: 29/10/1980 to 1/11/1980

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Fur was clipped from the dorsal area of the test animnals at least 24 hours prior to application. Two test sites were used per animal; one site was abraded using a hypodermic needle immediately prior to dosing. The skin of the other site was left intact.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per test site

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

Six; 3 females and 3 males

Details on study design:

TEST SITE
- Area of exposure: 3 cm2 per test site
- % coverage: Not reported
- Type of wrap if used:
Each dose was introduced under a square patch of surgical gauze measuring 1 inch by 1 inch and two single layers thick. Patches secured in place with Coban elastic bandage and Johnson and Johnson Zonas porous adhesive tape. The entire trunk of each animal was then wrapped with an impervious non-reactive material (such as plastic, 2 mils thick) and sealed at both ends to retard evaporation of volatile substances and to prevent the ingestion of the test material. A white cotton towel (15cm x 45cm) was then wrapped over the plastic and secured with Johnson and Johnson Zonas porous tape.

REMOVAL OF TEST SUBSTANCE
After the 24-hour exposure, the patches were removed and the skin was wiped, but not washed (unless necessary to observe the skin) to remove any test substance still remaining.

OBSERVATION TIME POINTS
A 30-minute period was allowed following removal of the test substance for pressure and hydration effects to subside. The animals were then scored for dermal reactions. Test sites were scored again after an additional 48 hours (i.e. 24 and 72-hour time points).

SCORING SYSTEM:
Irritation potential was scored according to the method of Draize (1944), as outlined in the Federal Hazardous Substances Act Grading Code at 16 CFR 1500.41. Primary irritation score was calculated as the total of the average scores for erythema / eschar formation and edema formation at 24- and 72-hours in either intact or abraded skin (8 values) divided by 4.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

other: Primary Irritation score = Total of average scores / 4

Time point:

other: 24/72 hr

Score:

5.38

Reversibility:

not specified

Remarks on result:

other: Primary dermal irritant

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Moderate to severe erythema

Remarks:

Intact skin

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Well-defined erythema

Remarks:

Intact skin

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Well-defined erythema

Remarks:

Intact skin

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Intact skin

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Moderate to severe erythema

Remarks:

Intact skin

Results 8

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Intact skin

Results 9

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Moderate to severe erythema

Remarks:

Intact skin

Results 10

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Intact skin

Results 11

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Moderate to severe erythema

Remarks:

Intact skin

Results 12

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Intact skin

Results 13

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

72 h

Score:

3

Reversibility:

not specified

Remarks on result:

other: Moderate to severe erythema

Remarks:

Intact skin

Results 14

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

3.67

Max. score:

4

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Remarks:

Intact skin

Results 15

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

2.83

Max. score:

3

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Remarks:

Intact skin

Results 16

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 17

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 18

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Well-defined erythema

Remarks:

Abraded skin

Results 19

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

not specified

Remarks on result:

other: Well-defined erythema

Remarks:

Abraded skin

Results 20

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 21

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 22

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 23

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 24

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 25

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 26

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 27

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

72 h

Score:

4

Reversibility:

not specified

Remarks on result:

other: Severe erythema to slight eschar formation

Remarks:

Abraded skin

Results 28

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

3.67

Max. score:

4

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Remarks:

Abraded skin

Results 29

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

3.67

Max. score:

4

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Remarks:

Abraded skin

Results 30

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Intact skin

Results 31

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 32

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Moderate edema

Remarks:

Intact skin

Results 33

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 34

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Intact skin

Results 35

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 36

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Intact skin

Results 37

Irritation parameter:

edema score

Basis:

animal #4

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 38

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Intact skin

Results 39

Irritation parameter:

edema score

Basis:

animal #5

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 40

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Intact skin

Results 41

Irritation parameter:

edema score

Basis:

animal #6

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 42

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3.83

Max. score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

probability of severe irritation

Remarks:

Intact skin

Results 43

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Intact skin

Results 44

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Abraded skin

Results 45

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 46

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Moderate edema

Remarks:

Abraded skin

Results 47

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 48

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Abraded skin

Results 49

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 50

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Abraded skin

Results 51

Irritation parameter:

edema score

Basis:

animal #4

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 52

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Abraded skin

Results 53

Irritation parameter:

edema score

Basis:

animal #5

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 54

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24 h

Score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

other: Severe edema

Remarks:

Abraded skin

Results 55

Irritation parameter:

edema score

Basis:

animal #6

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 56

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

3.83

Max. score:

4

Reversibility:

fully reversible within: 72 hours (no 48-hour scoring)

Remarks on result:

probability of severe irritation

Remarks:

Abraded skin

Results 57

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

Abraded skin

Results 58

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 59

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 60

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 61

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 62

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 63

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 64

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 65

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 66

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 67

Irritation parameter:

edema score

Basis:

animal #4

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 68

Irritation parameter:

edema score

Basis:

animal #5

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 69

Irritation parameter:

edema score

Basis:

animal #6

Time point:

48 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Other effects:

No abnormal behaviour was noted in any animal during the conduct of this study.

Any other information on results incl. tables

Primary irritation scores in six rabbits following a 24 -hour exposure:

Skin condition	Time (hr)	Animal number / sex						Total score	Average score
		1/M	2/M	3/M	4/F	5/F	6/F
Erythema and Eschar formation
Intact	24	4	2	4	4	4	4	22	3.67
Intact	72	3	2	3	3	3	3	17	2.83
Abraded	24	4	2	4	4	4	4	22	3.67
Abraded	72	4	2	4	4	4	4	22	3.67
Edema formation
Intact	24	4	3	4	4	4	4	23	3.83
Intact	72	0	0	0	0	0	0	0	0
Abraded	24	4	3	4	4	4	4	23	3.83
Abraded	72	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

A primary irritation score of 5.38 was calculated. The test substance was therefore considered to be a primary dermal irritant according to the FHSA Regulations at 16 CFR 1500.3, as referenced in the study report. Severe erythema was observed at both the 24- and 72-hour timepoints in intact and abraded skin. Severe edema was noted at the 24-hour time point but was reversible within 72-hours. Due to the lack of 14-day observation period in this study, it is unclear whether the erythema would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for skin corrosion/irritation under GHS and CLP. There is insufficient information to subcategorise.

Executive summary:

A study was conducted in order to evaluate the dermal irritation potential of the test substance in six New Zealand White rabbits (3/sex). The test sites were prepared by clipping the fur (dorsal trunk area) 24 hours prior to treatment. Two test sites (each approximately 3 cm²) were prepared within the clipped area per animal; one to the left of the spinal column and one to the right, with at least 3 cm of separation between test sites. On one site the skin was abraded immediately prior to treatment and on the other the skin was left intact. A dose of 0.5 ml test substance was applied to each site under semi-occlusive conditions for 24 hours. Following the exposure period, the test area was wiped and a 30 -minute period allowed for pressure and hydration effects to subside. The test areas were then scored for dermal reactions (erythema and edema). The animals were observed for an additional 48 hours (72 hours total) and the dermal reactions were then scored again. At the 24-hour time point, well-defined erythema to severe erythema was observed at both the intact and abraded test sites, as well as edema ranging from moderate to severe. At the 72 -hour time point, erythema ranged from well-defined to severe but no edema was noted. Due to the lack of 14-day observation period in this study, it is unclear whether the erythema would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for skin corrosion/irritation under GHS and CLP. There is insufficient information to subcategorise.