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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
old study

Test material

Constituent 1
Chemical structure
Reference substance name:
11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
EC Number:
249-227-9
EC Name:
11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
Cas Number:
28797-48-0
Molecular formula:
C14H10ClN3O2
IUPAC Name:
11-(chloroacetyl)-5,11-dihydro-6H-pyrido[2,3-b][1,4]benzodiazepin-6-one
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River , Germany- Age at study initiation: approx. 7 weeks- Weight at study initiation: 421.1 - 508.5 g- Housing: Animals were housed individually in Norly cages, type IV - Diet (e.g. ad libitum): Dry food in pellet form was supplied ad libitum - Water (e.g. ad libitum): Municipal drinking water was available at any time via drinking bottlesENVIRONMENTAL CONDITIONS- Temperature (°C): 17 - 23- Humidity (%): 45 - 75- Air changes (per hr): maximum 12- Photoperiod (hrs dark / hrs light): 12 : 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: ethanol
Concentration / amount:
1) 1 % suspension of L-S 519 / Chloracetyl in ethanol abs2) 2% suspension of L-S 519 / Chloracetyl in ethanol abs. and Freund'sComplete3) Freund's Complete Adjuvant with 0.9% NaCl solution
Day(s)/duration:
day 1 / injection
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
25% suspension of L-S 519 / Chloracetyl
Day(s)/duration:
day 8 - 10 / 48 h
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: ethanol
Concentration / amount:
25% suspension of L-S 519 / Chloracetyl
Day(s)/duration:
day 22 / 24 h
No. of animals per dose:
20 animals per test group10 animals per control group
Challenge controls:
10 female animals , 0.3 mL test item + ethanol
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: category 1A according CLP
Conclusions:
In the sensitisation test based on Magnusson and Klingman`s " Guinea Pig Maximisation Test" , L-S 519/Chloracetyl did induce allergic reactions by skin contact in 19 of the 20 guinea pigs treated. Thus, L-S 519/Chloracetyl revealed a sensitising potential under the stated study conditions.
Executive summary:

Objective:

The aim of the present study was to assess the allergic potential of L-S 519 / Chloracetyl following intradermal and topical occlusiv administration in guinea pig.

Design of Study :

A skin sensitisation study with L-S 519/Chloracetyl was carried out in guinea pig according to the " Guinea Pig Maximisation Test", using 2 groups of animals : a negative control group ( 10 females ) and a L-S 519 / Chloracetyl treated group ( 20 females) . The control group was treated during the sensitisation phase in an identical manner as the test group with the solvents used.

The animals of the L-S 519 / Chloracetyl group were treated as follows :

Day 1 : 3 pairs of intradermal injections with

a) 1% suspension of L-S 519 / Chloracetyl in ethanol abs.

b) 2% suspension of L-S 519 / Chloracetyl in ethanol abs. and Freund`s Complete Adjuvant ( ratio 1:1)

c) Freund`s Complete Adjuvant with 0.9% NaCl solution (1:1)

Day 8 to 10 : topical occlusiv application of a 25% suspension of L-S 519 / Chloracetyl in ethanol abs. to the same area of the skin

Day 22 : challenge of an allergic contact dermatitis by 24 hour topical occlusive application of a 25% suspension of L-S 519 /

Chloracetyl in ethanol abs.

The skin reaction were evaluated 24 and 48 hours after removal of the occlusive system.

Main results :

After the occlusive treatment on 22nd day of the study, no skin reactions were observed in the animals of the control group. In the L-S 519 / Chloracetyl treated group , 24 hours after removal of the occlusive system 19 animals showed moderate reddening of the whole area of application or severe reddening and swelling . 48 h after removal of the occlusive system, still 13 animals showed moderate reddening of the whole area of application or severe reddening and swelling.

Conclusion :

In the sensitisation test based on Magnusson and Klingman`s " Guinea Pig Maximisation Test" , L-S 519/Chloracetyl did induce allergic reactions by skin contact in 19 of the 20 guinea pigs treated. Thus, L-S 519/Chloracetyl revealed a sensitising potential under the stated study conditions.