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Description of key information

The key study determined the potential of the read-across source substance (Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol) to be sensitizing to skin. In a dermal sensitization study ten young adult Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligmann according to OECD 406. In this study, the read across substance was not a dermal sensitizer.

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 to 08 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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The in vivo study data were obtained in studies performed before any in vitro sensitization tests had been validated and accepted for regulatory purposes
Species:
guinea pig
Strain:
Dunkin-Hartley
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (F-69592 L'ABRESLE)
- Age at study initiation: 4 weeks
- Weight at study initiation: 240 to 276 g
- Housing: in polycarbonate containers, florring covered with dust-free cuttings, stainless steel lid
- Diet: ad libitum
- Water: d libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30-70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: 50% v/v isotonic sodium chloride for the induction phase, 50% v/v distilled water
Concentration / amount:
Induction phase: intredermal injection of 0.2%, epicutaneous application at 20%
challenge: 1% and 0.5% test material
Route:
epicutaneous, occlusive
Vehicle:
other: 50% v/v isotonic sodium chloride for the induction phase, 50% v/v distilled water
Concentration / amount:
Induction phase: intredermal injection of 0.2%, epicutaneous application at 20%
challenge: 1% and 0.5% test material
No. of animals per dose:
10 (5 control)
Details on study design:
RANGE FINDING TESTS:
intradermal injection ( determination of Maximal Non Necrotizing Concentration: MNNC)-5, 10, 25 and 50% test item 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 occlusive dressing
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. FCA in vehicle, 2. TM (Test Material) at 0.2% in vehicle, 3. FCA 50% v/v, 50% TM (0.4% v/v) in vehicle
epicutaneous- 0.5 mL TM (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
- Test groups: 1% and 0.5% 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.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.5 and 1%
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: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.5 and 1%
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: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.5 and 1%
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: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.5 and 1%
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: 0.5 and 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
6.25 and 12.5%
No. with + reactions:
10
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
6.25%
No. with + reactions:
9
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
12.5%
No. with + reactions:
10
Total no. in group:
10
Interpretation of results:
GHS criteria not met
Conclusions:
In view of this results, MARLON AMI 80 and hence,benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) are not a dermal sensitizers.
Executive summary:

In a dermal sensitization study with MARLON AMI 80 (78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol).Ten young adult Dunkin-Hartley guinea pigswere tested using the method of Magnusson and Kligmann according to OECD 406.α-Hexylcinnamaldehyde was used as apositive 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 1% and 0.5%. No cutaneous intolerance reaction was recorded in animals from the negative control group after thechallenge phase, on the treated area with the test item at 1% and 0.5%. 

In this study, MARLON AMI 80 and hence,benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) is not a dermal sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The key study determined the potential of the read-across source substance (Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol) to be sensitizing to skin. In the study the read across substance was not a dermal sensitizer.

In a supporting study, a group of 10 male and 10 female guinea pigs were used to determine the potential of the read across substance Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts 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 second read-across substance also was not sensitising to skin.

Justification for classification or non-classification

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