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Toxicological information

Skin sensitisation

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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:
23 Mar 1993 - 30 Apr 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions. No details on positive control (reliability check) given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted Jul 1992
Deviations:
yes
Remarks:
lack of details on positive control (reliability check) data
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed prior to the current amendment of Regulation (EC) No. 1907/2006 that specifies the Local lymphy node assay (LLNA) as the first-choice method for in vivo testing.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley, Pirbright White Bor: DHPW
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 401 ± 29 g
- Housing: conventional, 5 animals per cage in Makrolon Type IV
- Diet: Ssniff G 4 - Complete feed for guinea pigs (Ssniff, Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100%
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
A preliminary test was conducted in order to establish a non-irritant test substance concentration which could be used in the main test. Amounts of 0.4 mL of test substance preparations (25, 50 and 75% (w/w) in corn oil) and the undiluted test substance were applied to the skin of 4 animals under occlusive conditions. Exposure duration was 6 h, after which the patches were removed and the areas of application were wiped off with corn oil and a cellulose swab. Dermal reactions were assessed directly after patch removal and 24 and 48 h post-application according to the Draize scoring system for erythema and edema.
The mean erythema and edema scores out of all 4 animals over 6, 24 and 48 h post-application were both 0.0. Thus, no primary dermal irritation was observed on the skin of the treated animals up to a test substance concentration of 100% at any reading time point. Therefore, the main study was performed using the undiluted test substance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance
- Control group: corn oil
- Site: left flank
- 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
- Control group: test substance
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 6, 24, 48 and 72 h after application of the test substance.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
The sensitivity of the guinea pig strain used to reaction and effect of the known sensitiser 1-chloro-2,4-dinitrobenzene was stated to be checked at regular intervals (no further details provided).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
other: data on positive control not available

Any other information on results incl. tables

No test substance-related systemic effects were observed in the test or control animals. Body weight development was likewise not affected.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
CLP: not classified