Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

They study was performed in accordance with generally accepted scientific principles and presented as a short abstract. There was adequate reporting of the methodology and results. Based on the available information the study can be considered reliable, but with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The irritation potential of the undiluted test material was determined using 3 rabbits (2 male and 1 female). The clipped intact skin of each rabbit was exposed to the test material under an occlusive dressing for 24 hours. Animals were observed for signs of irritation for 7 days and scored in accordance with the Draize scale (1944).

GLP compliance:

no

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, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

EC Number:

701-356-6

Cas Number:

91696-74-1

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, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

Test material form:

liquid

Details on test material:

Actual material tested was HiTEC E 611

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

-Sex: Male and female

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- The test material was applied undiluted.

Duration of treatment / exposure:

24 hours.

Observation period:

7 days

Number of animals:

2 males and 1 female

Details on study design:

TEST SITE
- Preparation of exposure area: The skin of each animal was clipped and left intact.
- Type of wrap if used: The treated area was covered with plastic strips.

REMOVAL OF TEST SUBSTANCE
- The patch ws removed after 24 hours.

SCORING SYSTEM: Draize scale (1944).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 5 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 5 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No skin changes were noted after the first hour. Erythema ranging from barely perceptible to well-defined where one instance of slight edema developed in 24 hours, giving an average score of 2.0.
Following removal of the application, effects were reversible within 3 days in one animal and by day 5 in all others.

Any other information on results incl. tables

Table 1: Results

Animal No. and Sex	Irritation Score for Erythema and Edema, Hours After Removal
	1 Hour	24 Hours	48 Hours	72 Hours	120 Hours	168 Hours
1- Male	0	2	2	1	0	0
2- Female	0	1	1	0	0	0
3- Male	0	3	2	1	0	0
Average	0.0	2.0	1.6	0.6	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, slight to mild irritation was observed 24 hours after removal of the undiluted test material. This reaction was reversible in one animal after 3 days and after 5 days in the remaining two animals. The author of the report concludes that the test material is a slight to mild irritant, however the recorded irritation was not sufficient for classification in accordance with CLP; the test material is therefore determined to be not irritating.

Executive summary:

The irritation potential of the undiluted test material was determined using 3 rabbits (2 male and 1 female). No guideline was followed. The clipped intact skin of each rabbit was exposed to the test material under an occlusive dressing for 24 hours. Animals were observed for signs of irritation for 7 days and scored in accordance with the Draize scale (1944).

Under the conditions of the test, slight to mild irritation was observed 24 hours after removal of the undiluted test material. This reaction was reversible in one animal after 3 days and after 5 days in the remaining two animals. The author of the report concludes that the test material is a slight to mild irritant, however, the recorded irritation was not sufficient for classification in accordance with CLP; the test material is therefore determined to be not irritating.