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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 Sept. - 02 Oct. 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
reaction mass of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-) tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-) tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-) tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-) tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-) tert-alkyl(C12-C14)ammonium ((1-(4-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-(1,1-dimethylpropyl)phenylazo)-2-naphtholato))chromate(1-)
EC Number:
938-781-3
Cas Number:
117527-94-3
Molecular formula:
C21H21N304.C16H11N304.Cr unspecified.C12-C14 chain unspec.
IUPAC Name:
reaction mass of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-) tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-) tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-) tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-) tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-) tert-alkyl(C12-C14)ammonium ((1-(4-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-(1,1-dimethylpropyl)phenylazo)-2-naphtholato))chromate(1-)
Details on test material:
- Lot/batch No.: 217342.89
-Purity: not applicable (100% UVCB substance)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 13 weeks
- Weight at study initiation: 2447 - 2628
- Housing: plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20 °C
- Humidity (%): 50 - 75 %
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 29. September to 02. October 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
water
Controls:
no
Amount / concentration applied:
Three portions of 0.5 gram of the test substance were transferred into glass vials. Prior to treatment each portion was moistened with 0.5 ml Milli-RO water. Immediately thereafter, each portion of the prepared test substance was spread on a 6 cm^2 patch of Metalline and mounted on permeable tape.
Duration of treatment / exposure:
4 hours
Observation period:
Approximately 55 min, 24 hrs; 48 hrs; 72 hrs and additionally on day 4 after removal of the patches.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 10 cm x 10 cm
- Type of wrap if used: The animals were wrapped in flexible bandage

REMOVAL OF TEST SUBSTANCE
The remaining test substance was removed using a dry tissue subsequently a tissue moistened with tap-water

SCORING SYSTEM:
The exposed skin areas were examined for signs of erythema and oedema and the responses were scored (according to the grading system given in the OECD guideline 404) approximately 55 minutes, and 24, 48 and 72 hours and 4 days after removal of the patches. For reference the control site on the contralateral flank was used. In order to facilitate the scoring, the skin area concerned of all animals was shaved again at least 5 hours before observation on day 1.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean (24+48+72h)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean (24+48+72h)
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: day 4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean (24+48+72h)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean (24+48+72h)
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: day 4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean (24+48+72h)
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean (24+48+72h)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: day 4

Any other information on results incl. tables

Table 1: Primary skin irritation scores

  time animal 1 animal 2 animal 3
erythema 55 min  1
24 h  0
48 h  0
72 h  0
4 d  0 0 0
edema 55 min  0
24 h  0
48 h  1
72 h  1
4 d  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU