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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to GLP and meets OECD and EEC guideline requirements.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): T-4388
- Lot/batch No.: Lot 6
- Physical state: Colorless liquid
- Storage condition of test material: Test material was stored in the dark under ambient conditions

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Animals were supplied by David Hall Limited, Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: less than one year old
- Weight at study initiation: 370-487 g
- Housing: Twenty test group and 20 control group guinea pigs were housed 5 to a cage. Eight dose ranging guinea pigs were housed 4 to a cage in 2 further cages. Each aluminium cage had a grid floor beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): The animals were fed on FDI Guinea Pig Diet, supplemented with hay
- Water (e.g. ad libitum):Tap water ad libitum
- Acclimation period: Atleast 7 days prior to test commencement.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were 19º C and 18 º C.
- Humidity (%): Mean relative humidity was 46%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle (light hours 0700-1900 h)



IN-LIFE DATES: From: 28 March 1990 To: 27 April 1990

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction-Injection phase: 10% v/v in paraffin oil
Topical Application Phase: 100%
Challenge Phase: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction-Injection phase: 10% v/v in paraffin oil
Topical Application Phase: 100%
Challenge Phase: 100%
No. of animals per dose:
20 test, 20 control and 8 dose ranging guinea pigs
Details on study design:
RANGE FINDING TESTS:
A preliminary dose ranging test was carried out on 4 untreated guinea pigs. Two guinea pigs were subjected to intradermal injections and a further 2guinea pigs were exposed to topical application for 48 h of the test material at 4 different concentrations.
Injections and Topical application- 100%, 50%, 25% and 10% v/v in paraffin oil.
Injection sites were assessed for irritation 24, 48 and 72 h after injection and the topical application sites were assessed 24 h after patch removal.
Dose Ranging test for challenge: 4 guinea pigs were pretreated at the induction phase with Freund's Complete Adjuvant only. The test material was applied to the shaved flanks of guinea pigs for 24 h at 100% and 50% v/v in paraffin oil

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 24 h for both intradermal injection and topical application
- Test group: 20 guinea pigs
- Control group: 20 guinea pigs
- Challenge dose ranging group: 4 guinea pigs
- Site: dorsal surface
- Frequency of applications: 1
- Duration: Induction period consisted of an intradermal injection of the test material followed after one week by a topical application.
- Concentrations: 10% v/v in paraffin oil for intradermal injection and 100% for topical application


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3 weeks after commencement of induction procedure
- Exposure period: 24 h
- Site: dorsal surface
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h after patch removal


OTHER:
Positive control substance(s):
yes
Remarks:
2, 4-dinitro-chlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the results of the study T-4388 does not need to be classified as skin sensitizer according to EU criteria.

Executive summary:

The sensitization potential of a test material, T-4388 (colorless liquid, lot no. 6) was investigated by means of the Magnusson-Kligman Maximisation Test in guinea pigs. The report meets the requirements of OECD and EEC guidelines.

Forty eight young adult, nulliparous and non pregnant female albino guinea pigs of the Dunkin-Hartley strain, within the weight range 370-487 g at main test commencement were used. The sensitivity of this strain of guinea pig to a known sensitizer, 2, 4-dinitro-chlorobenzene (DNCB) is checked at 6 monthly intervals. The most recent positive control test with DNCB had 58% of the test group animals reacting positively.

Twenty test group and twenty control group guinea pigs were housed 5 to a cage. Eight dose ranging guinea pigs were housed 4 to a cage in 2 further cages. The animals were fed on FDI Guinea Pig Diet supplemented with hay and allowed food and tap water ad libitum.

Mean environmental maximum and minimum temperatures were 19ºC and 18 ºC and mean relative humidity was 46%. The guinea pigs were allowed an acclimatization period of at least 7 days prior to test commencement.

Main study animals were weighed at test commencement and completion.

Induction with T-4388 was at concentrations of 10% v/v in paraffin oil (injection) and 100% (topical). Challenge was at a concentration of 100%.

At challenge, none of the test or control group animals treated with T-4388 at a concentration of 100% showed a positive response.

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