3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The method used followed that described in the OECD Guidelines for Tesing of Chemicals No. 406 'Skin sensitisation' and Method B6 of 67/548/EEC.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

EC Number:

407-830-6

EC Name:

3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

Cas Number:

103335-54-2

Molecular formula:

Hill formula: C19H27NO3 CAS formula: C19H27NO3

IUPAC Name:

4a,6a-dimethyl-2-oxo-1H,2H,3H,4H,4aH,4bH,5H,6H,6aH,7H,8H,9H,9aH,9bH,10H-indeno[5,4-f]quinoline-7-carboxylic acid

Details on test material:

- Name of test material (as cited in study report): GR91287X
- Molecular formula (if other than submission substance): C19-H27-N-O3
- Molecular weight (if other than submission substance): 317.43
- Analytical purity: >95%
- Lot/batch No.: CO-0099
- Storage condition of test material: room temp in dark

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: David Hall Ltd
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 351-427 kg
- Housing: individually or in pairs in solid floor polypropylene cages with woodflakes
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48- 67
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: To: 1995-09-25 - 1995-10-29

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

arachis oil

Induction 2

Concentration / amount:

Intradermal induction - 5% w/v
Topical Induction - 50% w/v
Topical challenge - 25% and 10% w/v

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

arachis oil

Challenge 2

Concentration / amount:

Intradermal induction - 5% w/v
Topical Induction - 50% w/v
Topical challenge - 25% and 10% w/v

No. of animals per dose:

10 control and 20 tested.

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Control group: 3 injections, arachis oil, 50% arachis oil in freund's complete adjuvant with distilled water 1:1 in and freund's complete adjuvant with distilled water 1:1.
- Site: flanks
- Frequency of application: once
- Concentrations: intradermal: 5% w/v in arachis oil, 5% w/v in 1:1 mixture of freund's complete adjuvant plus distilled water and freund's complete adjuvant with distilled water 1:1.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24hrs
- Test groups: 1 (20)
- Control group: 1 (10)
- Site: flanks
- Concentrations: 0.1 -0.2 ml 25% w/w in arachis oil and 10% w/w in arachis oil
- Evaluation (hr after challenge): 24 and 48 hr

OTHER:

Results and discussion

Positive control results:

N/A

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25% and 10% w/w

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Animals No. 11-30: no results for animal 25 (found dead on day 18).

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% and 10% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Animals No. 11-30: no results for animal 25 (found dead on day 18)..

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25% and 10% w/w

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Animals No. 11-30: no results for animal 25 (found dead on day 18).

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% and 10% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Animals No. 11-30: no results for animal 25 (found dead on day 18)..

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced 0% (0/19) sensitisation rate and was classified as a non-sensitiser to guinea-pig skin. GR91287X does not require the risk phrase R43 'may cause sensitisation by skin contact' according to EC regulations.