Direct Yellow 169

Eye irritation

Administrative data

Endpoint:

eye 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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
- Analytical purity: main product 85.6 %
- Impurities (identity and concentrations): unknown coloured by-products 6.8 %; water 7.5%
- Composition of test material, percentage of components: main product 85.6 %; unknown coloured by-products 6.8 %; water 7.5%
- Purity test date: 1991-10-18
- Lot/batch No.: EN : SCR 905/TV
- Expiration date of the lot/batch: May, 1995
- Stability under test conditions: stable for at least 48 hours
- Storage condition of test material: in the original container, protected from light at approx. 20°C.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 g

Duration of treatment / exposure:

1 h

Observation period (in vivo):

1, 24, 48 and 72 hours after administration

Number of animals or in vitro replicates:

2 males
1 female

Details on study design:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Mean 24 - 72 hours

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

FAT 40'403/A was found to cause a primary irritation score of 0.00, when applied to the conjunctival sac of the rabbit eye.

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 eyes.