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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Guinea Pig maximisation study performed on amine
This is considered suitable to assess the ammonium salt as ammonium ions are known not to be potential sensitisers.

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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No known justification for not performing LLNA; however, as animal testing had been performed by the data owner, further animal work on LLNA was not justified.

Test material

Constituent 1
Reference substance name:
dodecylbenzenesulphonic acid, compound with isopropylamine
IUPAC Name:
dodecylbenzenesulphonic acid, compound with isopropylamine
Constituent 2
Reference substance name:
Dodecylbenzenesulphonic acid, compound with isopropylamine (1:1)
EC Number:
247-556-2
EC Name:
Dodecylbenzenesulphonic acid, compound with isopropylamine (1:1)
Cas Number:
26264-05-1
IUPAC Name:
2-dodecylbenzenesulfonic acid - propan-2-amine (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)

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.