Registration Dossier
Registration Dossier
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EC number: 308-114-5 | CAS number: 97862-65-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- EC Number:
- 308-114-5
- EC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Cas Number:
- 97862-65-2
- Molecular formula:
- C40H28CrN8O10S2.C28H31N2O3.C20H32N
- IUPAC Name:
- Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): drinking water, ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +-3 °C
- Humidity: 55 +/- 15 %
- Air changes: 15 per h
- Photoperiod: 12/12 h dark/light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 6 in total. 3 males and 3 females (two treatment sites per animal, one with intact skin, one with abraded skin).
- Details on study design:
- TEST SITE
- Clipping of the fur: 24 hours before study start, immediatly before treatment the shaven skin as slightly abraded.
- Area of exposure: approximately 6 cm2
- Type of wrap if used: impermeable material
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: The dressings were removed after 24 h.
SCORING SYSTEM: The skin reaction was assessed upon removal and during a subsequent observation period of 7 days on the basis of the evaluation scheme as described in OECD guideline 404 (2002).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- male (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female (intact skin)
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- None of the single animals exceeded an erythema or edema score of 2.
Any other information on results incl. tables
Additional observation made on abraded skin
Irritation parameter |
Basis |
Time point |
Score |
Max. score |
Reversibility |
erythema score |
mean male (abraded skin) |
24, 48, 72 h |
0.33 |
4 |
reversible within: 72 h |
erythema score |
mean female (abraded skin) |
24, 48, 72 h |
0.77 |
4 |
reversible within: 7 days |
edema score |
mean male (abraded skin) |
24, 48, 72 h |
0.33 |
4 |
reversible within: 72 h |
edema score |
mean female (abraded skin) |
24, 48, 72 |
0.77 |
4 |
reversible within: 7 days |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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