Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tripotassium/trisodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulfonato-6-(2-sulfonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-yl-(N-methyl)amino)phenyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulfonatophenylazo)naphthalene-2,7-disulfonate
EC Number:
402-150-6
EC Name:
Tripotassium/trisodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulfonato-6-(2-sulfonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-yl-(N-methyl)amino)phenyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulfonatophenylazo)naphthalene-2,7-disulfonate
Cas Number:
118578-11-3
Molecular formula:
Hill formula: C45H26Cl2K3N14Na3O20S6 C45H32Cl2N14O20S6.xK.xNa
IUPAC Name:
tripotassium trisodium 5-({4-chloro-6-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[2-(2-sulfonatophenyl)diazen-1-yl]naphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}phenyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[2-(2-sulfonatophenyl)diazen-1-yl]naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
CI Reactive Red 231

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mellor rabbits, Chedderton heights, Chedderton UK
- Weight at study initiation: 2000-2620 g for males and 1775-2736 g for females
- Housing: The rabbits were housed individually in satinised aluminium sheet cages (605mm width x 490mm depth x 455mm height). The floor of each cage was made of perforated aluminium sheet and the door was made of polycarbonate (MAKROLON).
- Diet (e.g. ad libitum): The animals were allowed free access to food and were given access to unlimited water via an automatic system.
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16°C
- Humidity (%): 50±10%
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light and 12 hours of darkness.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Moistened with water
Controls:
not specified
Amount / concentration applied:
Approximately 500 mg moistened with water
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: left flank
- Type of wrap if used: The treated area was covered with a piece of surgical gauze (approximate size 25mm x 25mm; 8 ply) which was secured by two crossed strips of surgical tape (approximate size 12mm x 80mm). This was covered by a piece of impermeable rubber sheeting (approximate size 350mm x 135mm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (75mm wide).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried gently with clean tissue paper.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)

1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draise system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Due to red color of the substance erythema score cannot be calulated
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Due to red color of the substance erythema score cannot be calulated
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Due to red color of the substance erythema score cannot be calulated
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Due to red color of the substance erythema score cannot be calulated
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Due to red color of the substance erythema score cannot be calulated
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Due to red color of the substance erythema score cannot be calulated
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 3 d
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 3 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 3 d
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 3 d
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 3 d
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the substance was not irritating to rabbit skin.
Executive summary:

A study was conducted to determine the skin irritation potential of the test substance according to a method similar to OECD Guideline 404, in compliance with GLP. New-Zealand White rabbits were exposed for 4 h to 0.5 g of test substance wetted with water. The experiment consisted in an occlusive coverage on clipped skin free of fur. Following application, animals were observed after 1, 24, 48 and 72 h. The mean scores for oedema were between 0 and 0.1 and all effects were reversible within 3 d. The erythema score could not be calculated because of red coloration of the skin due to the test substance. Under the study conditions, the substance was not irritating to rabbit skin (Pemberton, 1987).