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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:
22.10.2012 – 29.10.2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Guideline:
other: OECD Test Guideline No. 404 - Acute Dermal Irritation/Corrosion. Adopted 24th April 2002
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Name of test material (as cited in study report): Solvent Yellow 124
Substance type: organic
Physical state: liquid
Appearance: dark yellow viscous liquid

Composition of test material, percentage of components:
- Analytical purity: 90.0 % (w/w)
- Impurities (identity and concentrations):
4´-[2-((hydroxy)ethyl)ethylamino]azobenzene 3.0 % (w/w)
1,1-bis(N-ethyl[4-(phenylazo)phenyl]aminoethan-2-oxy)ethan 2.5 % (w/w)
- Unknown impurities 4.5 % (w/w)

Lot/batch No.: S2408
Expiration date of the lot/batch: Unlisted
Stability under test conditions: stable
Storage condition of test material: During the study the test substance was stored in glass bottle at laboratory temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
Weight at study initiation: 3.9-4.2 kg
Housing: individually in cages without bedding in conventional animal room
Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy))
Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
Temperature (°C): 17 - 23°C, permanently monitored
Humidity (%): 30 – 70 %, permanently monitored
Air changes (per hr): approximately 15 air changes per hour
Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

IN-LIFE DATES:
Animal supply: 17. 10. 2012
Experimental part of study: 22.10. – 29. 10. 2012

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 mg
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm
- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape - Spofaplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to the grading system given in Method B.4 Acute toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
Results of Clinical Observation
There was no evidence of a corrosive effect on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
No histopathology was performed.
Other effects:
Very slight erythema was observed in 1 hour after exposure only in rabbit No. 7. No skin reaction was observed in the other two rabbits. At 24, 48 and 72 hours after exposure no sign of erythema and oedema were recorded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance, Solvent Yellow 124, was tested for acute dermal irritation/corrosion.
Three rabbits were exposed to 0.5 mg of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at the 1, 24, 48 and 72 hours after exposure.
Very slight erythema was observed in 1 hour after exposure only in rabbit No. 7. No skin reaction was observed in the other two rabbits. At 24, 48 and 72 hours after exposure no sign of erythema and oedema were recorded. No evidence of a corrosive effect or symptoms of irritation were observed during all study on the skin of all animals.
No skin irritation was caused by 4-hour exposure of rabbits to Solvent Yellow 124.
Executive summary:

The test substance, Solvent Yellow 124, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test. Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

Three rabbits were exposed to 0.5 mg of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.

At first the test substance was applied on the skin of one rabbit (test animal No. 7). Rabbit

No. 7 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance.

In confirmatory test, two others rabbits (rabbit No. 8 and No. 9) were used with 4-hour exposition period.

Very slight erythema was observed in 1 hour after exposure only in rabbit No. 7. At 24, 48 and 72 hours after exposure no sign of erythema and oedema were recorded and no evidence of a corrosive effect or symptoms of irritation were observed on the skin of all animals.

No skin irritation was caused by 4-hour exposure of rabbits to Solvent Yellow 124.