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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: published data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Magnusson, B., and Kligman, A.M. (1969). The identification of contact allergens by animal assay. The guinea-pig maximization test. J. Invest. Dermat., 52, 268-276.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The identification of contact allergens by animal assay. Guinea pig maximisation test.
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Ltd., UK
- Weight at study initiation: 432-623 g
- Housing: 2-3 per cage of single sex, stainless steel cages with mesh floors, identified with colored body dye
- Diet (e.g. ad libitum): SG1 with vitamin C supplement, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 2 weeks

IN-LIFE DATES: From: September 5, 1983 To: October 21, 1983
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 0.05% m/v in corn oil
topical induction: 5% in corn oil
topical challenge: 2.5% in corn oil
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
intradermal induction: 0.05% m/v in corn oil
topical induction: 5% in corn oil
topical challenge: 2.5% in corn oil
No. of animals per dose:
10 animals per sex in test group
5 animals per sex in control group
Details on study design:
RANGE FINDING TESTS: The dorsal areas of two male and two females were closely short and shaved with an electric razor. 0.1 ml of several test dilutions were then injected. The concentrations tested were 0.05, 0.1, 0.5, and 1.0 %(m/v) of test substance in corn oil. These animals were observed for the next few days for toxicity. An additional two males and two females were exposed to 0.3 ml of 2.5, 5.0, 10.0, 20.0, and 50.0% of test substance in corn oil dermally for 24 hrs. At 24 and 48 hrs the animals were examined for signs of skin irritation.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two
- Test groups: The test group was first exposed by intradermal injection in the shoulder region. They were each given two injections of 0.1 ml each of Freund's complete adjuvant (FCA), 0.05% test substance in corn oil, and 0.05% of test substance in 50:50 FCA/corn oil. One week later, these same animals were given a dermal induction. The same area of skin was shaved. 0.3 ml of 5% test substance in corn oil was applied to a 4x4 cm2 patch of filter paper. This was applied to the skin and covered with Sleek dressing, which was then covered with Poroplast elastic adhesive bandage. Exposure was for 48 hrs.
- Control group: Control animals were treated in similar fashion with vehicle only.


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: two weeks after the topical induction
- Exposure period: 24 hrs
- Test groups: 0.1 ml of 2.5% test substance in corn oil was placed on a 3x3 cm2 piece of filter paper. A similarly sized piece of adhesive tape was used to cover it, and secured with Poroplast elastic adhesive bandage. Patches were removed after 24 hrs.
- Control group: Control group was exposed in a similar fashion.
- Site: flank
- Evaluation (hr after challenge): Sites were evaluated immediately after removal, and at 24 and 48 hrs after removal. Sites were scored using the Draize scale.

Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2.5% in corn oil
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2.5% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0.

No animals showed a positive response at the 24 and 48 hr readings.

Results of Skin Sensitisation Study

Animal

0 hrs after challenge

24 hrs after challenge

48 hrs after challenge

Test Group

2908 M

0

0

0

2909 M

0

0

0

2910 M

0

0

0

2941 M

0

0

0

2943 M

0

0

0

2934 F

1

0

0

2935 F

0

0

0

2936 F

0

0

0

2977 F

0

0

0

2978 F

0

0

0

2918 M

0

0

0

2919 M

0

0

0

2920 M

1

0

0

2945 M

0

0

0

2946 M

1

0

0

2937 F

0

0

0

2938 F

0

0

0

2940 F

0

0

0

3001 F

1

0

0

3003 F

0

0

0

Control Group

2947 M

0

0

0

2948 M

0

0

0

2950 M

0

0

0

3024 M

0

0

0

2961 F

0

0

0

2963 F

0

0

0

2964 F

0

0

0

3004 F

0

0

0

3005 F

0

0

0

 

Interpretation of results:
other: not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance is not sensitising to skin.
In a guinea-pig maximization test none of the test animals showed positive responses at 24 or 48 hours after removal of the challenge patches. The test material showed no sensitizing potential in guinea pigs.
Executive summary:

A group of 10 male and 10 female guinea pigs were used to determine the potential of the test substance to be sensitising to skin. The animals were first given an intradermal induction of 0.05% of test substance in corn oil. One week later, they were given a dermal induction of 5% test substance in corn oil. A group of 5 male and 5 female guinea pigs were used as controls. These animals were treated in a similar fashion with vehicle only. Two weeks after the dermal induction, a challenge was performed via dermal exposure to 2.5% test substance in corn oil. The control group was exposed as well. The animals were exposed for 24 hrs. Skin irritation readings were made at 24 and 48 hrs after the end of exposure. No positive responses were seen in either the test or control group. The test substance is not sensitising to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

No evidence of sensitisation in the study of Rose, G.P.1984.The test substance (Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)) as a surrogate for Sodium dodecylbenzenesulfonate (CAS#; 25155-30-0) is not sensitising to skin.

 

In a guinea-pig maximization test none of the test animals showed positive responses at 24 or 48 hours after removal of the challenge patches. The test material showed no sensitizing potential in guinea pigs.

 

This result can be reliably be read across to the substance Sodium dodecylbenzenesulfonate (CAS# 25155-30-0)

 

 Synopsis

Not sensitising

 

 In other study of RBM. 1985 the test substance(LAS(as a read across)) is not sensitizing to skin.

This test determined the potential of the test substance to be sensitizing to skin. 10 male and 10 female guinea pigs were given intradermal injections of 25% test solution. Control animals (5 male and 5 female) were given injections of vehicle only. One week later, a second induction was done by dermal exposure to 25% test solution for 24 hrs. Control animals were again exposed to vehicle only. On day 21, the challenge exposure was performed. All animals were exposed to 12.5% test solution dermally. Exposure was for 24 hrs, with observations made at 48 and 72 hrs after the start of exposure. No positive reactions were noted. The test substance is not sensitizing.

 

This result can be reliably be read across to the substance Sodium dodecylbenzenesulfonate (CAS# 25155-30-0)

 

Synopsis

Not sensitising

 

 


Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance Sodium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for Inhalation - local effect: skin sensitisation.

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation: in chemico
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Respiratory sensitisation.

There are no Respiratory sensitisation studies available.

 Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.

Sodium dodecylbenzenesulfonate is of low priority for further work based on a low hazard potential.is of low priority for further work based on a low hazard potential.

Synopsis

Not Sensitising


Migrated from Short description of key information:
There are no Respiratory sensitisation studies available.
Due to the absence of chemical groups or other structural alerts this substance is not considered to exhibit an high hazard potential.
Sodium dodecylbenzenesulfonate is of low priority for further work based on a low hazard potential.is of low priority for further work based on a low hazard potential.
Therefore testing for Respiratory sensitisation does not need to be performed.

Justification for classification or non-classification

Based on the hazard assessment of Sodium dodecylbenzenesulfonate in section 2.1 and 2.2. in IUCLID 5.4., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Respiratory Sensitisation Xn

R42 May cause sensitization by inhalation

Respiratory Irritation Xi

R37 irritating to respiratory system

CLP

Respiratory Sensitisation

H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled

Respiratory Irritation

H335 STOT SE 3 May cause respiratory irritation

It is concluded that the substance Sodium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards forInhalation - local effect: respiratory sensitisation.

 

 

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