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Registration Dossier
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EC number: 266-405-1 | CAS number: 66557-45-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March/April 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Method was not available
Test material
- Reference substance name:
- N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- EC Number:
- 258-110-1
- EC Name:
- N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- Cas Number:
- 52697-38-8
- Molecular formula:
- C18H19BrN6O5
- IUPAC Name:
- N-{2-[(2-bromo-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide
- Test material form:
- solid: bulk
- Details on test material:
- Dispersol Blue H69507
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
albino Dunkin-Hartley guinea pigs
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, U.K.
- Weight at study initiation: 333 - 393g
- Age: seven to eleven weeks
- Housing: groups of up to 4
- Diet: Guinea Pig FD1 Diet, Special Diet Services Limited, Witham, Essex, U.K. ad libitum
- Water: tap water ad libitum
- Acclimatisation period: five days,
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 25°C
- Humidity (%): 45 to 60%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16. March To: 26. April 1987
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 1% / 2 x 0.1 mL
1% / 2 x 0.1 mL in arachis oild : Freund's Complete Adjuvant (FCA) 1:1 - Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25% (w/w) in petroleum jelly B.P. / 0.2 to 0.3 mL
- Day(s)/duration:
- on Day 8 for 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25% (w/w) in petroleum jelly B.P. / 0.1 to 0.2 mL
- Day(s)/duration:
- on Day 22 for 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Determination of primary not irritating concentration: 4
Determination of intradermal tolerability: 2
Control group: 10
Treatment group: 20 - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- yellow/green coloured staining of skin
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- yellow/green coloured staining of skin; one animal not evaluable due to skin alterations was counted as positive
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- yellow/green coloured staining of skin; one animal not evaluable due to skin alterations was counted as positive
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow/green coloured staining of skin
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow/green coloured staining of skin
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- yellow/green coloured staining of skin
Any other information on results incl. tables
Yellow/green coloured staining of the skin was noted at the majority of test sample sites but did not prevent assessment of the skin responses.
Positive skin responses (erythema score >1) were noted at fourteen of the test sample sites on the test animals at the 24-hour observation. Slight loss of skin suppleness was also noted at one of these sites at this time.
A positive skin response had developed at one additional test sample site on the test animals at the 48-hour observation. A further observation was therefore made 72-hours after dressing removal but no additional positive
skin responses were noted. Common signs of desquamation and occasional signs of superficial cracking and thickening of the skin were apparent at the test sample sites on the test animals at both the 48 and 72-hour
observations.
No adverse skin reactions were noted at the vehicle control sites on the test animals or test sample or vehicle control sites on the control animals at the 24, 48 or 72-hour observations.
Bodyweight gains of surviving guinea pigs in the test group, between day 0 and day 24, were comparable to those observed in the control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test substance caused positive reactions in 70%, 55% and 20% of animals after 24, 48, and 72 hours after removal of the test substance; it is hence considered to be a skin sensitiser.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test sample in the albino guinea pig. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 406 "skin Sensitisation" - Magnusson and Kligman Maximisation Test.
Twenty test and ten control animals were used for the main study.
Following sighting studies, the following concentrations were used in the induction and challenge phases:
Intradermal Induction 1% (w/v) in arachis oil
Topical Induction 25% (w/w) in petroleum jelly
Topical Challenge 25% (w/w) in petroleum jelly
Yellow/green coloured staining of the skin was noted at the majority of test sample sites but did not prevent assessment of the skin responses.
Positive skin responses (erythema score >1) were noted at fourteen of the test sample sites on the test animals at the 24-hour observation. Slight loss of skin suppleness was also noted at one of these sites at this time.
A positive skin response had developed at one additional test sample site on the test animals at the 48-hour observation. A further observation was therefore made 72-hours after dressing removal but no additional positive
skin responses were noted. Common signs of desquamation and occasional signs of superficial cracking and thickening of the skin were apparent at the test sample sites on the test animals at both the 48 and 72-hour
observations.
No adverse skin reactions were noted at the vehicle control sites on the test animals or test sample or vehicle control sites on the control animals at the 24, 48 or 72-hour observations.
Bodyweight gains of surviving guinea pigs in the test group, between day 0 and day 24, were comparable to those observed in the control group animals over the same period.
The test substance caused positive reactions in 70%, 55% and 20% of animals after 24, 48, and 72 hours after removal of the test substance; it is hence considered to be a skin sensitiser.
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