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Toxicological information

Skin sensitisation

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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

Test material

Constituent 1
Chemical structure
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
Molecular formula:
N/A
IUPAC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine
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)

Inductionopen allclose all
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
Challengeopen allclose all
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

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)

Resultsopen allclose all
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.

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 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.