Benzenesulfonic acid, 4-C10-12-sec-alkyl derivs.-, compds. with 2-propanamine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 October-16 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

The scientific literature (eg ref 1) indicates that for surfactant materials such as Benzenesulfonic acid, 4-C10-C13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1), the LLNA study can give false positive results. Therefore, a Guinea Pig Maximisation Test was undertaken rather than the LLNA.
Ref 1: Ball et al (2011). Evaluating the sensitization potential of surfactants: Integrating data from the local lymph node assay, guinea pig maximization test, and in vitro methods in a weight-of-evidence approach

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine

EC Number:

284-664-9

EC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine

Cas Number:

84961-74-0

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1)

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine (1:1)
- Substance type: technical product (BIO-SOFT 411-E)
- Physical state: viscous liquid
- Analytical purity: 97%
- Lot/batch No.: 50148
- Expiration date of the lot/batch: 30 June 2013
- Storage condition of test material: room temperature in the dark

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: 4 weeks
- Weight at study initiation: 237-269 g
- Housing: in groups of two or individually, in polycarbonate containers
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

other: isotonic sodium chloride

Induction 2

Concentration / amount:

Induction phase: intradermal injection of 0.5%, epicutaneous application at 20%
challenge: 0.5% and 0.25% test material

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: isotonic sodium chloride

Challenge 2

Concentration / amount:

Induction phase: intradermal injection of 0.5%, epicutaneous application at 20%
challenge: 0.5% and 0.25% test material

No. of animals per dose:

10 (5 for control)

Details on study design:

RANGE FINDING TESTS:
intradermal injection ( determination of Maximal Non Necrotizing Concentration: MNNC)-0.1 ml of the test material at 5, 10, 25 and 50% in isotonic sodium chloride. Necrosis was seen in all dose levels, and hence, lower concentrations were tested: 0.2, 0.5, 1 and 2%

topical application
1.determination of the Pre-Maximal Non Irritant Concentration (Pre-MNIC): 10, 20, 50, 100% in distilled water, 24 h with occlusive dressing. Excessive irritation was seen, and therefore, two more animals were tested at 7.5% and 5% in water.
2. determination of the Maximal Non Irritant Concentration: 1, 2, 5 and 10% in distilled water

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections and one epicutaneous application
- TEST GROUPS:
intradermal- 1. 50% FCA in vehicle, 2. TM (Test Material) at 0.5% in vehicle, 3. FCA 50% v/v, 50% TM (1% v/v) in vehicle
epicutaneous- induction of local irritation at the testing site with 10% sodium lauryl sulphate in thick vaseline (Day 6)
Day 7: 0.5 mL TM at 20% in distilled water, occlusive dressing for 48 hours

-CONTROL GROUP:
intradermal- 1. 50% FCA in vehicle, 2. vehicle, 3. FCA at 50% in vehicle (equal volumes)
epicutaneous- 0.5 mL distilled water

- Site: scapular zone
- Frequency of applications: day 0 (intradermal) and day 7 (epicutaneous)
- Duration: 0-9 days

B. CHALLENGE EXPOSURE
- Exposure period: 24 h (occlusive dressing)
- Test groups: 0.5% and 0.25% test material
- Site: dorso-lumbar area

Positive control substance(s):

yes

Remarks:

α-Hexylcinnamaldehyde

Results and discussion

Positive control results:

α-Hexylcinnamaldehyde showed positive results, i.e. it exerted allergenic reactions on the guinea pigs tested.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.25%, and 0.5%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.25%, and 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.25%, and 0.5%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.25%, and 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.25% and 0.5%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.25% and 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.25% and 0.5%

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.25% and 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

MNNC determination: no necrosis was seen at 0.5% and below

Pre MNIC determination: severe and moderate erythema was seen at doses 7.5 -100%. Slight to moderate erythema was seen at 5%

MNIC determination: slight to moderate erythema was seen at 2%, and moderate erythema at 1%. No reaction was seen at 0.5 and 0.25%.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In view of this result, ,benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (1:1) is not a dermal sensitizer.

Executive summary:

In a dermal sensitization study with BIO-SOFT 411 -E (97% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2 -propanamine (1:1), ten young adult Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligmann according to OECD 406.α-Hexylcinnamaldehyde was used as a positive control material. No cutaneous reaction attributable to allergy was recorded in animals from the treated group after the challenge phase, with the test item at 0.25% and 0.5%. No cutaneous intolerance reaction was recorded in animals from the negative control group after the challenge phase, on the treated area with the test item at 0.25% and 0.5%. 

In this study, benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2 -propanamine (1:1) is not a dermal sensitizer.