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

Endpoint summary

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:

LAS MIPA

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 pigs were tested using the method of Magnusson and Kligmann according to OECD 406. In this study, MARLON AMI 80 and hence, LAS MIPA were not dermal sensitizers.

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:

The information available suggests that the substance is not a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

LAS MIPA does not induce sensitisation after dermal contact and therefore, it shall not be classified for skin sensitisation, according to the criteria laid down on EC Regulation 1272/2008.