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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 11, 1990 - January 18, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline 404 study, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
EC Number:
408-210-8
EC Name:
Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
Cas Number:
124605-82-9
Molecular formula:
C33 H26 N8 O14 S4 .x Li .x Na
IUPAC Name:
tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-2-methylazobenzene
Details on test material:
- Physical state: powder
- Stability under test conditions: stable for at least 2 hours

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., 4414 Fuellinsdorf
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.7 kg, females: 2.5 - 2.9 kg.
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: Pelleted standard Kliba 341, Batch 50/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: Four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3 °C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: bi-distilled water
Controls:
other: the untreated skin of the same animals served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: surgical gauze covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormalities observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no abnormalities observed
Irritant / corrosive response data:
The test substance showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
Other effects:
In the area of application a blue staining of the treated skin by pigment or coloring of the test article was observed in all animals between 1 to 72 hours (termination of the study).
Female no. 32 lost weight during acclimatization period. Male no. 31 and female no. 33 lost weight during treatment period.

Any other information on results incl. tables

No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.

No necropsy was performed. All animals were killed and discarded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test article caused no skin reactions and is therefore considered to be not irritating to the rabbit skin.
Executive summary:

In a GLP-compliant skin irritation study performed according to OECD guideline 404, three New Zealand White rabbits were treated semi-occlusively with 0.5 g of the test article moistened with bi-distilled water. The test article was applied to the clipped dorsal area of the animals and held in place for 4 hours by a semi-occlusive dressing. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches and animals were checked daily for signs of systemic toxicity. Under the experimental conditions employed the test article did not induce any reactions to the skin. The test article is therefore classified as non irritating.