2,4-bis(((2-(dimethylammonio)ethyloxy)carbonyl)phen-2-ylazo)benzene-1,3-diolbis(methanesulfonate)

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: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96 %
- Lot/batch No.: 6123 V. 6781

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Savo; Med Versuchstierzuchten GmbH; Kisslegg
- Weight at study initiation: 2.2 (female) - 2.41(male) kg
- Housing:cage made of stainless steel with wire mesh walk floor; floor area 40 cm X 51 cm
- water:250 ml/d tap water
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): central air conditioning guaranteed a range of 20 -24 degrees celsius
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 - 18.00 hours/ 18.00 - 6.00 hours)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied : 0.5 ml

Duration of treatment / exposure:

Exposure period: 4 h

Observation period:

72 h

Number of animals:

2 male; 1 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of th exposure period with Lutrol and Lutrol/water (1:1)
SCORING SYSTEM:
OECD Draize Score

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4- 24- 48 - 72 h

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 - 24 -48 - 72 hours

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification: not irritating