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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:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
study predates GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
276-481-8
EC Name:
Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
72214-18-7
Molecular formula:
C32H26ClN7O11S3.3Na
IUPAC Name:
hexasodium 1-amino-4-{[3-({4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate 1-amino-4-{[3-({4-chloro-6-[(4-sulfophenyl)amino]-1,3,5-triazin-2-yl}amino)-2,4,6-trimethyl-5-sulfophenyl]amino}-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
Test material form:
other: Granulate
Details on test material:
None
Specific details on test material used for the study:
Company code: FAT 41001/D
Batch No: EN 94060.32
Purity: 78.8 %
Appearance: Granulate
Stability of the test compound: until November 1988
pH-value: 7.6 (lg/1 water)
Test article received: December 6, 1983

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
- Age at study initiation:12 - 14 weeks
- Weight at study initiation: 2000-2260 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): Water were provided ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1. 24, 48, 72 hours
Number of animals:
3 females
Details on study design:
SCORING SYSTEM:
After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, (cf. Table 1), after 1, 24, 48, 72 hours and during the following observation period. The score obtained is defined as the "index of primary cutaneous irritation".

INDEX CLASSIFICATION
<0.5 non irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 irritant
5.1 - 8.0 severely irritant

Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well defined by definite raising): 2
- Moderate oedema (raised approximately 1 millimeter): 3
- Severe oedema (raised more than 1 millimeter and extending beyond the area of' exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: only 1 animal could beassessed due to strong colouring of the skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The animals showed a normal body weight development. Starred figures indicate impossibility of scoring due to intensive blue staining by the test compound. The scoring was performed after the values for edema only.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 41001/D is non-irritant and not corrosive when applied to the rabbit skin; the test was terminated after 3 observation days.
Executive summary:

The purpose of this study was to evaluate the primary skin irritation in Albino rabbits with compound FAT 41001/D. The test was carried out according to OECD guideline 404. Not less than 24 hours before treatment on the back of the experimental animal an area was shaven of at least 6 sq.cm by means of an electric clipper. 0.5 ml of the test substance was applied to the skin by means of gauze and loosely held in place by adhesive but non irritating tape for a period of 4 hours. Erythema scoring was possible only in one animal since intensive staining was observed in other animals. The mean 24/48/72h score was recorded to be 0.33 for animal #1. The mean 24/48/72h oedema score was recorded to be 0. The animals showed a normal body weight development. No other reactions to treatment were recorded during the whole observation period. Based on the findings of the study, it can be concluded, that FAT 41001/D is non-irritant and not corrosive when applied to the rabbit skin. The test was terminated after 3 observation days.