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Toxicological information

Skin sensitisation

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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

Constituent 1
Chemical structure
Reference substance name:
2-hydroxy-3-[(3-{[3-(4-methoxyphenyl)prop-2-enoyl]amino}propyl)(dimethyl)ammonio]propane-1-sulfonate
EC Number:
695-243-8
Cas Number:
500731-87-3
Molecular formula:
C18H28N2O6S
IUPAC Name:
2-hydroxy-3-[(3-{[3-(4-methoxyphenyl)prop-2-enoyl]amino}propyl)(dimethyl)ammonio]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)

Resultsopen allclose all
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
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.