Calcium dodecylbenzenesulphonate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7) as a surrogate for Benzenesulfonic acid, dodecyl-, calcium salt-(26264-06-2)

Reason / purpose for cross-reference:

read-across source

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:

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.

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.

Reference 2

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

C12 LAS; Linear Alkylbenzene Sulfonate (LAS)) is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

Directive 179/831 Annex, Part B.

GLP compliance:

not specified

Type of study:

other: Guinea pig maximization test

Justification for non-LLNA method:

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.

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200-350 g
- Housing: Makrolon cages, 5 per cage
- Diet (e.g. ad libitum): 8GP17 guinea pig food, ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 degree C
- Humidity (%): 60 +/- 20%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Route:

other: intracutaneously and epicutaneously

Vehicle:

water

Concentration / amount:

Induction concentration was 25% in water and Freund's Adjuvant; the challenge concentration was 12.5% in deionized water

Route:

other: no data

Vehicle:

water

Concentration / amount:

Induction concentration was 25% in water and Freund's Adjuvant; the challenge concentration was 12.5% in deionized water

No. of animals per dose:

10 male and 10 female

Details on study design:

Induction
Induction was first done by intradermal injection. Test animals were injected with 0.1 ml Freund Complete Adjuvant (FCA), 0.1 ml of 25% test substance in water, and 0.1 ml test substance in FCA in water (final concentration 25%). Control group was treated in a similar manner with only FCA and water. On day 7, a second, epicutaneous challenge was done. 0.5 ml of test susbtance (25%) was placed on gauze, and then placed on the animals. The animals were than bandaged, and the test substance remained in contact for 48 hrs. Control animals were exposed to vehicle only.

Challenge
0.2 ml of 12.5 % test article was placed on gauze, which was then placed on the test and control animals. Gauze containing only vehicle was placed on the left flank. The exposure lasted 24 hrs. Observations for irritation were made at 24 and 48 hrs after the end of exposure. Skin was scored for irritation using the Draize scale.

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.2 ml of 12.5% test solution

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no positive responses were observed

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml of 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no positive responses were observed.

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

0.2 ml 12.5% test solution

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 20.0.

Reading:

1st reading

Hours after challenge:

72

Group:

negative control

Dose level:

0.2 ml 12.5% test solution

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

2nd reading

Hours after challenge:

72

Group:

negative control

Dose level:

0.2 ml 12.5% test solution

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.2 ml 12.5% test solution. No with. + reactions: 0.0. Total no. in groups: 10.0.

Interpretation of results:

other: not sensitising

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test substance is not sensitizing to skin.

Executive summary:

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.

Reference 3

Endpoint:

skin sensitisation: in chemico

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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 Calcium dodecylbenzenesulfonate 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 Calcium dodecylbenzenesulfonate (CAS#  26264-06-2)

 

 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 Calcium dodecylbenzenesulfonate (CAS# 26264-06-2)

 

Synopsis

Not sensitising

 

 

Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance Calcium 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

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.

Calcium 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.
Calcium 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 Calcium dodecylbenzenesulfonate in section 2.1 and 2.2. in IUCLID 6., 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 Calcium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.