2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one hydrochloride

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6th Nov 1996 - 29 November 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: done under GLP and OECD method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source:Charles River France
- Age at study initiation: 7 weeks old
- Weight at study initiation: 450 g+-100 g
- Housing:wire mesh bottom stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):free access to tap water
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20+-2C
- Humidity (%): 45-75
- Air changes (per hr):10-12
- Photoperiod (hrs dark / hrs light):12/24

IN-LIFE DATES: From:november 6 To:November 29

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

paraffin oil

Induction 2

Concentration / amount:

Concentration of test material and vehicle used at induction: 6 animals - right flank 40%, left flank -20% and then 6 animals 5% right flank and 10% left flank . The concnetration retained for the final assay was 10% w/v

Topical application: 50% w/w in arachis oil BP

Concentration of test material and vehicle used for each challenge:
50% and 25% w/w in arachis oil BP

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

paraffin oil

Challenge 2

Concentration / amount:

Concentration of test material and vehicle used at induction: 6 animals - right flank 40%, left flank -20% and then 6 animals 5% right flank and 10% left flank . The concnetration retained for the final assay was 10% w/v

Topical application: 50% w/w in arachis oil BP

Concentration of test material and vehicle used for each challenge:
50% and 25% w/w in arachis oil BP

No. of animals per dose:

Number of animals in test group: 20
Number of animals in negative control group: 20

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 - intadermal and occlusive
- Exposure period: 8 days
- Test groups: 20 males
- Control group: 20 males
- Site: intradermal injections 0.1 ml (10%) at D1, occlusive bandage (48hr) 0.9 ml (40%) at D8
- Frequency of applications:
- Duration: 48 hr
- Concentrations:0.1 ml (10%) at D1; 0.9 ml (40%) at D8

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: D21
- Exposure period:24hr occlusive bandage
- Test groups: 20
- Control group:20
- Site:left flank control; right flank test substance
- Concentrations:0.2 ml of 10%
- Evaluation (hr after challenge):24 and 48 hr after treatment- local reaction (erythema, edema)

OTHER:

Challenge controls:

20 males with vehicle only

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

other: induction phase

Group:

test chemical

Dose level:

10% and 40%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

no cutaneous reaction

Remarks on result:

other: Reading: other: induction phase. Group: test group. Dose level: 10% and 40%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no cutaneous reaction.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10%

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

slight erythema that cleared up at 48 hours

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erythema that cleared up at 48 hours.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

10%

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

slight erthyema that cleared up at 48 hours

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erthyema that cleared up at 48 hours.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The test substance has no cutaneous sensitizing activity in guines pigs.