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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:
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
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

Route:
intradermal and epicutaneous
Vehicle:
other: isotonic sodium chloride
Concentration / amount:
Induction phase: intradermal injection of 0.5%, epicutaneous application at 20%
challenge: 0.5% and 0.25% test material
Route:
epicutaneous, occlusive
Vehicle:
other: isotonic sodium chloride
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
Positive control results:
α-Hexylcinnamaldehyde showed positive results, i.e. it exerted allergenic reactions on the guinea pigs tested.
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.
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.
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.
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.

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%.

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 pigswere 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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

LAS IPA

In one dermal sensitization study with benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2 -propanamine (97%), ten young adult Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligmann. 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%. Base on this result LAS IPA is not a dermal sensitizer.

Supporting information

LAS Na:

One test available examined the senistisation potential of LAS Na to the 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.


Migrated from Short description of key information:
One study is available examining the skin sensitisation potential of benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (LAS IPA). The result of the study shows that the the substance is not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
This is the only study available examining the sensitisation potential of LAS IPA. It is a GLP, Guideline study, which fully addresses this endpoint requirement.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Data show that benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2 -propanamine is not a dermal sensitiser and it shall not be classified and labeled as a skin sensitiser, according to the criteria laid down in CLP (EC) Regulation 1272/2008.