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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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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. 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

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, barium salts, barium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
Molecular formula:
Not possible, UVCB
IUPAC Name:
Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, barium salts, barium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

Test animals

Species:
rabbit
Strain:
not specified

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:
Three
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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1.6
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1.3
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0.6
Max. score:
8
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
48 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24 h
Score:
2
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
Following removal of the application, effects were reversible within 3 days in one animal and by day 5 in all others.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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 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. 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.