Registration Dossier
Registration Dossier
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EC number: 407-250-3 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline- and GLP-compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- 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): FAT 40'403/A
- Physical state: yellowish, solid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4 CH-4414 Fullinsdorf
- Age at study initiation: males : 7 weeks; female: 8 weeks
- Weight at study initiation: males: 403 - 448 g; females: 285 - 470 g
- Housing:Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel",
Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 342, Batches 57/90 and 58/90 guinea pig breeding/maintenance diet ("Kliba", Klingentalmuhle AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum):Community tap water from Itingen, ad libitum.
- Acclimation period: One week under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Physiological saline was used as vehicle for the intracutaneous and petrolatum-oil for the epicutaneous applications
- Concentration / amount:
- Induction
Intradermal injections: Test group:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) The test article, diluted to 5% with physiological saline.
3) The test article at the concentration used in (2), emulsified in a 50:50
mixture of Freund's complete adjuvant and the vehicle used in (2).
Epidermal applications:
non-irritant concentration (25% in petrolatum-oil)
Challenge:
non-irritant concentration (25% in petrolatum-oil)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Physiological saline was used as vehicle for the intracutaneous and petrolatum-oil for the epicutaneous applications
- Concentration / amount:
- Induction
Intradermal injections: Test group:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) The test article, diluted to 5% with physiological saline.
3) The test article at the concentration used in (2), emulsified in a 50:50
mixture of Freund's complete adjuvant and the vehicle used in (2).
Epidermal applications:
non-irritant concentration (25% in petrolatum-oil)
Challenge:
non-irritant concentration (25% in petrolatum-oil)
- No. of animals per dose:
- 5 males, 5 females for the control group and 10 males, 10 females for the test group.
- Details on study design:
- RANGE FINDING TESTS: none
MAIN STUDY
A. INDUCTION EXPOSURE
Approximately 24 hours prior to the epidermal application the test area was pre-treated with 10 % Sodium-Lauryl-Sulfat (SLS) in petrolatum-oil, because no primary irritation concentration could be determined in the corresponding pre-test. The SLS was massaged into the skin with a glass rod without bandaging. This SLS-concentration enhances sensitization by provoking a mild inflammatory reaction.
- No. of exposures: Three pairs of intradermal injections; 2 x 4 cm patch of filter paper (saturated with the test article)
- Exposure period: 48 h (occulsive)
- Test groups:
- Control group: The guinea-pigs of the control group were treated with the omission of test article.
- Site: dorsal skin from the scapular region
- Frequency of applications: Three pairs of intradermal injections, once occulsive patch
- Duration: 48 hrs
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: guinea-pigs were challenged two weeks after the epidermal induction application
- Exposure period: 24 hrs
- Test groups:
- Control group: The control animals were treated in the same way
- Site: left and right flank
- Evaluation (hr after challenge): The sites were assessed for erythema and edema immediately, 24 and 48 hours after removal of the dressing,
using the numerical scoring system as described under preliminary study
- Challenge controls:
- yes, 25% of the substance applied
- Positive control substance(s):
- yes
- Remarks:
- HCHO
Study design: in vivo (LLNA)
- Statistics:
- Fisher-Test (The Exact Fisher Test for comparison of the basic probability of two binomial distributions. L. Sachs, Statistische Auswertungsmethoden, Georg Thieme Verlag, Stuttgart 1971).
For calculation of p-values the 24-hour reading of the animals from the control and test group was used.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance is not sensitizing to skin.
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