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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
01 Nov 1995 - 01 Dec 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study with acceptable restrictions (during induction phase the scapolar region was treated instead of flank; during challenge the right and left top flank were treated with test substance; details on positive control not given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
During the induction phase the scapolar region was treated instead of flank; during challenge the right and left top flank were treated with the test substance; no details on the positive control given
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: liquid
- Colour: light straw
- Analytical purity: 99%
- Lot/batch No.: REF 17727/6
- Storage condition of test material: at ambient temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK, Ltd, Manston Rd, Margate, Kent or Harlan Porcellus, Firgrove Farm, Cross-in-Hand, Heathfield, Sussex, UK
- Weight at study initiation: 250-450 g
- Housing: not further specified
- Diet: RGP Guinea Pig diet supplied by Labsure, Lavender Mill, Manea, Cambridgeshire, UK
- Water: mains
- Acclimation period: at least 6 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ±2
- Humidity (%): 55 ±15
- Air changes (per hr): 25-30 per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 100%
Challenge: 100% and 30%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Induction: 100%
Challenge: 100% and 30%
No. of animals per dose:
10 (control), 20 (in test groups)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: corn oil
- Site: scapular region
- Frequency of applications: every 7 days
- Duration: Days 0-14
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test substance in corn oil
- Control group: test substance in corn oil
- Site: top left flank (test substance 100%) and top right flank (test substance 30%)
- Concentrations: 100% and 30%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Positive control substance(s):
yes
Remarks:
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
Scattered mild redness
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Scattered mild redness.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
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: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
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.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified