Registration Dossier
Registration Dossier
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EC number: 276-558-6 | CAS number: 72275-69-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 28, 1994 to June 23, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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
- Justification for non-LLNA method:
- A LLNA skin sensitisation study does not need to be conducted because adequate data from an other in vivo skin sensitisation study is available
Test material
- Reference substance name:
- Similar substance 1
- IUPAC Name:
- Similar substance 1
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production
- Weight at study initiation: 338 to 421 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: The animals received ad libitum standard guinea pig pellets NAFAG No. 845
- Water: ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
- No. of animals per dose:
- PRETEST
test group
5 per sex doses
control group
5 X sex for controls.
MAIN TEST
test group
10 X sex X dose
cotrol group
5 X sex X dose - Details on study design:
- PRETESTS
INDUCTION EXPOSURE INTRADERMAL INJECTIONS
- Test groups: 5 guinea-pigs
- Concentrations: 5 % in physiological saline (w/v).
Since 5 % in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
INDUCTION EXPOSURE: Epi dermal applications
- Exposure period:
- Test groups: 5 guinea pigs
- Concentrations:
A = 30 %
B = 50 %,
50% was the highest possible concentration of the test article in physiological saline.
The tested concentrations did not induce erythema reactions.
MAIN STUDY
A1. INDUCTION EXPOSURE:
- No. of exposures: Three pairs of intradermal injections (0.1 ml/site)
- Exposure period: performed on test day 0:
- Test groups: 20 guinea pig
- Control group: 10 guinea pig
- Site: left and right side of the shaved neck of the test and control group animals.
- Duration: Three pairs of intradermal injections
- Concentrations:
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % in physiological saline (w/v)
- 5 % in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
A2. INDUCTION EXPOSURE: Epidermal applications
- No. of exposures: one patch
- Exposure period: performed on test day 8
- Test groups: 20 guinea pig
- Control group: 10 guinea pig
- Site: the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch
- Duration: 48 hours
- Concentrations:
Test group:
- 50 % in physiological saline
Control group:
- physiological saline only
B. CHALLENGE EXPOSURE
- No. of exposures: one patch
- Day(s) of challenge: performed on test day 22
- Exposure period:24 hours
- Test groups: 20 guinea pig
- Control group: 10 guinea pig
- Site: tested on one flank (patch 2x2 cm; approx. 0.2 g per patch, occluded administration)
- Concentrations:
Test and control group:
- 50 % in physiological saline
- physiological saline only - Challenge controls:
- Induction reactions
The animals were pretreated with 10% sodium-laurylsulfate on day 7. - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% in the adjuvant/saline mixture (w/v)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% in the adjuvant/saline mixture (w/v). No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: Erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% in the adjuvant/saline mixture (w/v)
- 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: 5% in the adjuvant/saline mixture (w/v). No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 hours after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- Not sensitizer
- Executive summary:
The substance was tested for skin sensitisation according The OECD 406 guideline and 92/69/EEC, B.6 method.
Under the experimental conditions employed, 5 % of the animals of the test group showed skin reactions 24 hours after removing the dressings.
Under the test condition, the substance does not show any sensitisation potential, therfore is considered to be non sensitizer.
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