Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
26 Mar - 26 Apr 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions. Lack of test material details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
lack of test material details
GLP compliance:
yes
Type of study:
guinea pig maximisation 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: straw-coloured liquid
- Analytical purity: no data
- Storage condition of test material: at room temperature

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 Limited, Burton-on-Trent, U.K.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 345-438 g
- Housing: animals were housed in groups of up to 5 in solid-floor polypropylene cages furnished with softwood shavings.
- Diet: Guinea Pig FD1 Diet (Special Diet Services Limited, Witham, U.K.), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 50-60
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Preliminary study:
Intradermal: 10, 25 %
Epicutaneous: 50, 100%

Main study:
Induction:
Intradermal: 25 %
Epicutaneous: 100%
Challenge: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
arachis oil
Concentration / amount:
Preliminary study:
Intradermal: 10, 25 %
Epicutaneous: 50, 100%

Main study:
Induction:
Intradermal: 25 %
Epicutaneous: 100%
Challenge: 100%
No. of animals per dose:
10 (controls), 20 (in test group)
Details on study design:
RANGE FINDING TESTS:
Groups of 1-2 guinea pigs were used and up to 2 dose levels were tested to identify the dose levels for the main study. Dilutions of the test material in arachis oil B.P. were tested to determine the highest practical level (10, 25 % (w/v)) that could be intradermally injected and well tolerated both locally and systemically. For topical application, the undiluted test substance and dilutions of the test material in petroleum jelly B.P. (50, 75 and 100%) were tested to determine the highest level which did not produce excessive inflammation on the animal with FCA. To identify the highest level which did not produce inflammation or irritation after topical application on the animal with FCA, the undiluted test substance and dilutions of the test material in petroleum jelly B.P. (50, 75 and 100%) were tested. Based on the results of the range finding tests, concentrations of 25 and 100% were selected for intradermal and epicutaneous treatment, respectively.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/arachis oil
Injection 2: test substance in arachis oil
Injection 3: test substance in a 1:1 mixture (v/v) FCA/arachis oil

Epicutaneous: undiluted test substance

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/arachis oil
Injection 2: arachis oil
Injection 3: a 1:1 mixture (v/v) FCA/arachis oil

Epicutaneous: same procedure as for the test material group without substance application

- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 25%, epicutaneous 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 48 and 72 h
Positive control substance(s):
yes
Remarks:
formaldehyde 40% (w/v)

Results and discussion

Positive control results:
The sensitivity of the strain used, is checked at approximately six month intervals according to the OECD 406 Guideline. The here cited study with 0.1% (w/v) intradermal injection, 50% (w/v) topical application and 10% (w/v) topical challenge induced a positive result in 19/20 (95%) animals (March 1987, Project Number SF/6), thus meeting the reliability criteria (at least 15%).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 100%
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: induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 25%; challenge: 100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 25%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 100%
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: induction: 0%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 25%; challenge: 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: induction: 25%; challenge: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Preliminary test:

In the preliminary test no effects on skin or systemic toxicity were observed in the test animals after intradermal injection of 10 and 25% (w/v) of the test substance in arachis oil. 1 h after topical application of 50, 75 and 100% (w/w) in petroleum jelly B.P., 2/4 animals showed scattered mild redness which was fully reversible within 24 h.

Main study:

After the topical induction with the undiluted test substance, immediately after removal of the dressing, 17 /20 animals showed scattered mild redness and 3/20 animals showed moderate erythematous reaction, respectively. No skin reactions were observed for the negative control animals after topical induction with the blank patch.

No skin reactions were observed after challenge in all animals after 24 and 48 h.

Bodyweight gains of guinea pigs in the test group, between Day 0-24, were comparable to those observed in the control group animals over the same period.

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