3-(N-p-methoxy cinnamidopropyl-N,N-dimethyl ammonium)-2-hydroxypropane-1-sulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

09 October 2001 to 03 November 2001

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study is well conducted but its design not sufficient to cover the endpoint

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: IS 13424, 1992

GLP compliance:

not specified

Type of study:

other: Similar to guinea pig maximisation test

Justification for non-LLNA method:

Available data.

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate

EC Number:

695-243-8

Cas Number:

500731-87-3

Molecular formula:

C18H28N2O6S

IUPAC Name:

2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate

Test material form:

other: liquid

Details on test material:

- Name of test material: Galaxy-Sunbeat-MM-30
- Physical state: colourless liquid
- Lot/batch No.: MM 30

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Study design: in vivo (non-LLNA)

Induction

Route:

other: topical

Vehicle:

water

Concentration / amount:

0.1 ml of 50% solution

Day(s)/duration:

4 inductions

Challenge

Route:

other: topical

Vehicle:

water

Concentration / amount:

0.05 ml of 50% solution

Day(s)/duration:

Single challenge

Adequacy of challenge:

highest non-irritant concentration

Results and discussion

Positive control results:

The positive control gave results as expected

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50%

No. with + reactions:

0

Total no. in group:

6

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

5%

No. with + reactions:

6

Total no. in group:

6

Clinical observations:

Results from Irradiated Site

Any other information on results incl. tables

Results:

Dermal irritation scores of animals of irradiated and non-irradiated sites of test group are shown in Table 1. The positive control results are shown in Table 2.

Table 1: Challenge Reaction in Animals of Test Group

Test site	Animal No	Dermal Irritation Scores
Non Irradiated Site	1	0
	2	0
	3	0
	4	0
	5	0
	6	0
Irradiated Site	1	0
	2	0
	3	0
	4	0
	5	0
	6	0

Table 2: Challenge Reactions in Animals of Positive Control Group

Test site	Animal No	Dermal Irritation Scores
Non Irradiated Site	7	0
	8	0
	9	0
	10	0
	11	0
	12	0
Irradiated Site	7	2
	8	2
	9	2
	10	3
	11	3
	12	2

Applicant's summary and conclusion

Interpretation of results:

other: not photo-sensitising

Conclusions:

Treatment of guinea pigs with the test substance followed by irradiation did not produce any evidence of allergic reaction. The results of irradiated sites were comparable to non-irradiated sites in the test group animals. Following the scoring and evaluation of challenge patch test reactions, it was concluded that the test substance did not have any photo allergic potential in albino guinea pigs.