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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:
1971
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: USDA Regulation (Federal Register 34, No. 64, April 4, 1969)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts
EC Number:
293-346-9
EC Name:
Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts
Cas Number:
91078-64-7
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of naphtalene, butanol, sulfonated and neautralized by caustic soda
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
other: Albino rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
other: The dorsal regions of 12 albino rabbits are depilated, the skin sites of 6 animals additionally being scarified
Vehicle:
not specified
Duration of treatment / exposure:
24 hours
Observation period:
24, 48, 72 hours
Number of animals:
12 rabbits (the skin sites of 6 animals being scarified)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: redness and swelling
Basis:
animal: 1 (intact) and 15 (scarified)
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
other: redness and swelling
Basis:
animal: 2 (intact) and 16 (scarified)
Time point:
24/48/72 h
Score:
0.75
Reversibility:
not specified
Irritation parameter:
other: redness and swelling
Basis:
animal: 3 (intact) ,17 (scarified), 4 (intact) and 18 (scarified)
Time point:
24/48/72 h
Score:
1
Reversibility:
not specified
Irritation parameter:
other: redness and swelling
Basis:
animal: 5 (intact) and 19 (scarified)
Time point:
24/48/72 h
Score:
0.25
Reversibility:
not specified
Irritation parameter:
other: redness and swelling
Basis:
animal: 6 (intact) and 20 (scarified)
Time point:
24/48/72 h
Score:
0.5
Reversibility:
not specified

Any other information on results incl. tables

Irritant effect on the skin of rabbits

The results are summarized in the table below.

Animal number

Effect on the skin

Result

Skin

intact

Skin

scarified

after 24 hour

after 72 hours

intact

scarified

intact

scarified

1

15

R 0

R 0

R 0

R 0

0

S0

S 0

S 0

S 0

2

16

R 0

R 1

R 0

R 2

0.75

S 0

S 0

S 0

S 0

3

17

R 0

R 2

R 0

R 2

1.0

S 0

S 0

S 0

S 0

4

18

R 0

R 2

R 0

R 2

1.0

S 0

S 0

S 0

S 0

5

19

R 0

R 0

R 0

R 1

0.25

S 0

S 0

S 0

S 0

6

20

R 0

R 0

R 0

R 2

0.5

S 0

S 0

S 0

S 0

Result: no primary irritant effect

Applicant's summary and conclusion

Interpretation of results:
other: not classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008
Conclusions:
The test item is not irritant.
Executive summary:

The skin irritation potential of the substance was evaluated following the Guideline USDA Regulation (Federal Register 34, No. 64, April 4, 1969). Twelve albino rabbits (six intact and six scarified) were exposed to the substance for 24 hours in an occlusive coverage. 24 h, 48 h, 72 h, after the beginning of application the rabbits were observed for signs of redness and swelling

Based on the mean scores obtained, the test item is not irritant to the rabbit skin.