Alkylbenzenesulphonic acid compound with alkanolamine

Skin sensitisation

Some information in this page has been claimed confidential.

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

other: the tested substance is the acid part of the compound

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

2016

Materials and methods

Test guideline

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.

Principles of method if other than guideline:

an LLNA study does not need to be conducted because adequate data assessed with a different method at an earlier date is available

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

an LLNA study does not need to be conducted because adequate data assessed with a different method at an earlier date is available

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: liquid

Details on test material:

Dobanic acid 103 (Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)) as a surrogate for Benzene sulfonic acid, dodecyl (CAS# 27176-87-0)

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

corn oil

Induction 2

Concentration / amount:

intradermal induction: 0.05% m/v in corn oil
topical induction: 5% in corn oil
topical challenge: 2.5% in corn oil

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Challenge 2

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.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

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.

Results 2

Key result

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.

Results 3

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.

Results 4

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.

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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.