Direct Yellow 169

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline- and GLP-compliant study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): FAT 40'403/A
- Physical state: yellowish, solid

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. Wolferstrasse 4 CH-4414 Fullinsdorf
- Age at study initiation: males : 14 weeks; female: 15 weeks
- Weight at study initiation: males : 2.4 - 2.5 kg; female: 3.2 kg
- Housing:Individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 53/90 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum):Community tap water from Itingen, ad libitum.
- Acclimation period:Four days under test conditions after veterinary examination.


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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g


VEHICLE
- Amount(s) applied (volume or weight with unit): moistened

Duration of treatment / exposure:

4 h

Observation period:

The skin reaction was assessed at 1, 24, 48 and 72 hour intervals after the
removal of the dressing, gauze patch and test article.

Number of animals:

2 males
1 female

Details on study design:

TEST SITE
- Area of exposure: dorsal
- % coverage: 10 cm X 10 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: mean 1 hour to 72 hours

Score:

0

Max. score:

0

Reversibility:

other: not relevant

Irritant / corrosive response data:

Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and
grade 0.00 edema.

No corrosive effect had occurred on the skin at any measuring interval.

Other effects:

In the area of application, yellow staining of the treated skin by pigment or
coloring of the test article was observed in all treated animals until termination
of observation (72 nours).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not irritant to skin.