1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Human maximization testing of D & C Yellow no.10 and Yellow no. 11

Author:

Kita S., Kobayashi T., Kutsuna H. and Kligman A.M.

Year:

1984

Bibliographic source:

Contact dermatitis, 1984, 11, 210-213

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A maximisation test was performed on humans. 15 subjects were exposed to five skin applications of the test item (5% in water) on upper right arm using Duhring chamber (120 mm in diameter) (induction). These skin applications were on sites pre-treated with an irritant (Sodium lauryl sulphate). After 10 days rest period, the forearm human skin was challenged by a 5% solution of the test substance applied in Finn Chambers for 48 hours. The challenge site was evaluated at 48 and 72 hours using a conventional 5-point grading scale.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

EC Number:

305-897-5

EC Name:

1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts

Cas Number:

95193-83-2

Molecular formula:

C18H11NO5S to C18H8NO11S3.3Na

IUPAC Name:

trisodium hydrogen bis(2-(1,3-dioxo-5-sulfonato-2,3-dihydro-1H-inden-2-yl)quinoline-8-sulfonate)

Method

Type of population:

not specified

Ethical approval:

confirmed, but no further information available

Remarks:

Informed consent was obtained.

Subjects:

- Number of subjects exposed: 35.
- Sex: Not specified.
- Age: between the age of 18 and 43 years .
- Race: Caucasian.
- Test facility: the test was carried out at the Ivy Research laboratories, Inc. (Philadelphia, USA) .

Clinical history:

Not reported.

Controls:

Not reported

Route of administration:

dermal

Details on study design:

RANGE FINDING TESTS: Not specified

MAIN STUDY
INDUCTION EXPOSURE
No. of exposures: 5
Exposure period: 48 hours
Test groups: 15 human subjects
Control group: not specified
Site: upper right arm
Concentrations: 5%

CHALLENGE EXPOSURE
- Day(s) of challenge: 10 days after induction
- Exposure period: 48 hours
- Concentrations: 5%
- Evaluation: 48 and 72 hours after challenge. The challenge was evaluated using a conventional 5-point grading scale:
0 – 0.5, doubtful reaction
1, weak positive
2, Strong positive with papules and vesicles
3, extreme with bullae
The results were given in terms of:
- proportion sensitised to exposed
- mean intensity of the reaction .

Results and discussion

Results of examinations:

Number of subjects with positive reactions: 0/15 (both at 48 and 72 hours).

Applicant's summary and conclusion

Conclusions:

Under the conditions of the study, the test item did not induce skin sensitisation in any of the 15 subjects.

Executive summary:

A maximisation test was performed of humans. 15 subjects were exposed to five skin applications of the test item (5% in water) on upper right arm using Duhring chamber (120 mm in diameter) (induction). These skin applications were on sites pre-treated with an irritant (Sodium lauryl sulphate). After 10 days rest period, the forearm human skin was challenged by a 5% solution of the test substance applied in Finn Chambers for 48 hours. The challenge site was evaluated at 48 and 72 hours using a conventional 5-point grading scale. Under the conditions of the test, the test item did not induce skin sensitisation in any of the 15 subjects.