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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reived publication

Data source

Reference
Reference Type:
publication
Title:
Human maximization testing of D & C yellowNo.10 and Yellow no. 11
Author:
Sehchi Kita, Toshiaki Kobayashi, Hiroshi Kutsuna and Albert M.Kligman
Year:
1984
Bibliographic source:
Contact dermatitis 1984:11: 210-213

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Maximization study was conducted to evaluate the sensitizing potential of the test compound D & C yellow no 10.
GLP compliance:
no
Type of study:
other: Maximization test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D & C yellow no 10
- Molecular formula (if other than submission substance): C18-H9-N-O8-S2.2Na
- Molecular weight (if other than submission substance): 477.3801 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations):
Sample 1: 38-170 ppm Di- and tri- sodium sulphonated derivatives of quinonaphthalone
Sample 2: 1 ppm Monosodium sulfated derivatives.

In vivo test system

Test animals

Species:
human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Healthy Caucasian Volunteers
- Age at study initiation: 18 to 43 years
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum):v
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Remarks:
Distilled
Concentration / amount:
5%
Challenge
Concentration / amount:
5%
No. of animals per dose:
15 human subjects
Details on study design:
RANGE FINDING TESTS: No data available

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Five
- Exposure period: 48 hr for each exposure
- Test groups: 15
- Control group: No data available
- Site: Upper right arm
- Frequency of applications: 5
- Duration: No data available
- Concentrations: 5%


B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations No data available
- Evaluation (hr after challenge): No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data available

In vivo (non-LLNA)

Results
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
15
Remarks on result:
other: . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 15.0.

Any other information on results incl. tables

other details not known

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test chemical D & C yellow no 10 is not sensitizing to the skin of humans.
Executive summary:

Maximization test was performed to study the sensitizing potential of the test chemical D & C Yellow no.10. 5% of the test chemical was used in the induction phase. Five 48 hrs exposure were given on the upper right arm using Duhring chambers (120 mm in diameter) on sites pretreated with sodium lauryl sulfate.

 

None of the 15 subjects exposed to induction doses of 5% test chemical in water became sensitized. The test chemicalD & C yellow no 10 is thus not sensitizing to the skin of humans.

 

As per the CLP classification, the test material does not classify as a skin sensitizer.