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EC number: 942-925-0 | 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)
- Rationale for reliability incl. deficiencies:
- other: guideline study under GLP condition
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Azo zinc complex pigment - melamine compound
- IUPAC Name:
- Azo zinc complex pigment - melamine compound
- Test material form:
- other: brown powder
- Details on test material:
- Molecular weight 615.79
Lot no.BOS3479-3105
purity/content: 100 %
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:6 weeks
- Weight at study initiation: 313.2 - 381.6 g
- Housing: 5/cage
- Diet ad libitum
- Water. ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%):50
- Air changes (per hr) 10 - 15:
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: sterile water
- Concentration / amount:
- induction abd challenge 25 %
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: sterile water
- Concentration / amount:
- induction abd challenge 25 %
- No. of animals per dose:
- 20 in the treatment group; 10 for posive control 10 for negative control
- Details on study design:
- preliminary test : 25 %
main study
Induction exposure day 0, 7, 10
the fur on one flank was closely clipped with a hair clipper before the treatment day. On the treatment day 0.5 ml each of the test substance absorbed in a patch was attached to cover the test area and maintained using elastic bandage for 6 hours. in the control groups ( negative : distilled water; positive: DNCB) substances were applied in a similar manner to the test area. te same application as on day 0 was carried out on the same test area of the same flank on day 7 and again on day 14.
Challenge exposure: day 27
The untreated flank of treated and control animals were clipped on the day prior to the challenge patch application. To the treated and negative contol animals patches which absorbed 0.5 ml of the test substance were attached to the test area and maintained uling elastic bandage for 6 hours. In the positive control group DNCB was applied in a similar manner to the test area.
Approximately 21 hours after removing the patch of the challenge area the sites were wiped gently with gauze and the challenged sites and surrounding area was shaved. At 3 hours later the skin reactions were evaluated. An additional evaluation was made 24 hours later
further observations: clinical signs, body weight development - Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- positive control (DNCB) was functional
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- 1 animal was killed in moribund state with left hindling caught in bottom of the dabe on day 25
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 1 animal was killed in moribund state with left hindling caught in bottom of the dabe on day 25.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Clinical observations:
- no observations reported
- 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: 19.0. Clinical observations: no observations reported.
- Reading:
- other: 1st abd 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reacrions observed
- Remarks on result:
- other: Reading: other: 1st abd 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reacrions observed.
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: other: 1st and 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1 %. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: erythema.
Any other information on results incl. tables
1/20 animal in the treatment group was moribund with left hindlimb caught in bottom of the cage on day 25 and was sacrifced.
no treatment related mortality; no clinical signs, normal increase in body weight
Applicant's summary and conclusion
- Executive summary:
The study was conducted to evaluate the skin sensitisation of Azo zinc pigment complex - melamine compound according to OECD TG 406 under GLP condition using the Buehler test procedure in guinea pigs. Parameters measured during the study period were mortality, clinical signs, body weight changes and skin reactions. The follwing results were obtained:
1/20 animal in the treatment group was moribund with left hindlimb caught in bottom of the cage on day 25 and was sacrifced.
No treatment-related mortality or clinical signs were observed during the study period
All living animals showed a normal increase in body weight
At the 24 and 48 hours after challenge with the test substance of 25 % there was no skin reaction seen in any of the test guinea pigs as seen in the negative control animals. The positive control (DNCB) animals (8/10) showed significant erythema
Thus, this result indicates that Azo zinc pigment complex - melamine compound is considered to have no skin sensitising potency in guinea pigs by Bühler test under the conditions of the study.
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