Registration Dossier
Registration Dossier
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EC number: 701-428-7 | CAS number: -
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- When this study was performed, the LLNA did not yet exist.
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Homogeneity: homogeneous
- Physical state/ Appearance: Solid / blue
- Storage conditions: Room temperature
Constituent 1
- Specific details on test material used for the study:
- C. I. Pigment Blue 15:3
Lot INCU 002025
blue powder
Purity:>95%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Mol:DH (Moellegaard)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: M & B A/S, DK-8680 Ry Denmark
- Microbiological status of animals, when known: no data
- Weight at study initiation: mean 318g
- Housing: 5 animals per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least five days
- Indication of any skin lesions: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C (except short lasting deviations due to disturbances of air condition)
- Humidity (%): 50 ± 20 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 5%
- Day(s)/duration:
- single
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- intradermal
- Vehicle:
- other: 50 % Freund 's Complete Adjuvant emulsion
- Concentration / amount:
- 5%
- Day(s)/duration:
- single
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- 2
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24h
- Adequacy of challenge:
- other: highest technically achievable concentration
- No. of animals per dose:
- 10 (Treatment group)
5 (control group)
3 (range-finder for non-irritant concentration) - Details on study design:
- DETERMINATION OF THE PRIMARY NON-IRRITATING CONCENTRATION
Prior to the determination of the primary non-irritation concentration in a dermal-occlusive test three animals each received 4 intradermal injections of a 50% Freund's Complete Adjuvant emulsion (4 x 0.1 mL) into the dorsal area, since Freund' s Complete Adjuvant may lower the threshold of primary irritation. Thereafter, the test substance was administered to the right or left flank of the guinea pigs according to the following procedure:
Table 2: Distribution of the test concentrations (dermal)
Animal No. Left flank Right flank
1 25 % in sesame oil 5 % in sesame oil
2 25 % in sesame oil 1 % in sesame oil
3 5 % in sesame oil 1 % in sesame oil
The hair on the flanks of the animals was removed mechanically. 0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 hours with a bandage and film. 24 hours after removal of the patches, the treated skin areas were examined for erythema and edema
DETERMINATION OF THE TOLERANCE OF THE INTRADERMAL INJECTIONS
To determine the tolerance of intradermal injections, each of the following preparations was administered twice by intradermal injection to 2 guinea pigs. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulders.
The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulders
Table : Test concentrations
site appl. vol. conc. vehicle
1 2 x 0.1 ml 5.0 % sesame oil
2 2 x 0.1 ml 1.0 % sesame oil
3 2 X 0.1 ml 0.2 % sesame oil
24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance.
Intradermal injections with Freund's Adjuvant (with and without test substance) caused clear edema as well as indurations. The administration sites treated with the test substance in sesame oil showed clear edema. Intradermal injections of the vehicle alone exhibited two animals showed slight erythema. Due to the blue color of the test substance the treated skin of the animals could not be assessed for erythema.
Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at day 7. - Challenge controls:
- Animals with induction treatment of 50 % Freund's Adjuvants or sesame oil
- Positive control substance(s):
- yes
- Remarks:
- Alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- After the challenge treatment 9 animals of the treatment group (90 %) showed a positive reaction during the observation period.
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:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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
- 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
Any other information on results incl. tables
No skin reactions were observed in the control and the treatment group 24 and 48 hours after removal of the occlusive bandage. Additionally, the treated skin was discolored light blue which did not influence the assessment of skin reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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