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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:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted non-GLP, with limited data on study design, however the study was conducted according to state of the art methods at that time period. The study is considered adequate, reliable and relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals, 72h observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: slightly viscous liquid
Details on test material:
- Name of test material (as cited in study report): Aerosol TR-70 sodium Bis-tridecyl Sulfosuccinate
(70% aqueous solution)
- Physical state: Not provided, but it is assumed that the test material is a slightly viscous liquid
- Analytical purity : 70%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided


Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Not provided

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of the product as received
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
2.3
Max. score:
8
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: no data on 48 h observation

Any other information on results incl. tables

Table1. Rabbit skin irritation results

Time,

Hours

Reaction

Rabbit Number, Value

Mean

Value

1

2

3

4

5

6

 

ERYTHEMA

 

 

 

 

 

 

 

24

intact

2

2

2

2

1

2

1.8

72

intact

1

1

2

2

1

1

1.3

24

abraded

2

2

2

2

1

2

1.8

72

abraded

1

1

1

2

1

0

1.0

 

EDEMA

 

 

 

 

 

 

 

24

intact

0

2

2

4

1

1

1.7

72

intact

0

0

0

1

0

1

0.3

24

abraded

0

0

0

4

2

1

1.2

72

abraded

0

0

0

1

0

0

0.2

Structure of the tissue at the site of contact was not destroyed or changed irreversibly in 24 hours or less.

Primary Irritation Score: 2.3 (Sum of the mean values divided by 4)

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The Primary Skin Irritation score of the test item Butanedioic acid, sulfo-, 1,4-ditridecyl ester, sodium salt ( 70% active ingredient) was 2.3.
Executive summary:

0.5 mL of Butanedioic acid, sulfo-, 1,4-ditridecyl ester, sodium salt (70% active ingredient) was held under an impervious patch in continuous 24-hour contact with the shaved skin of 6 rabbits. Erythema and edema were observed in all animals on abraded and intact skin at 24 hours, which had not reversed by 72 hours. The overall primary irritation score was 2.3. The structure of the tissue at the site of contact was not destroyed or changed irreversibly within 24 hours.