Reaction products of diazotised 5-aminonaphthalene-1-sulfonic acid, coupled with diazotised 1-naphthylamine and 8-anilinonaphthalene-1-sulphonic acid, potassium sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read across from analogous substance

Adequacy of study:

key study

Study period:

From 4th to the 11th of September, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same 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)

Deviations:

yes

Remarks:

Slight modifications from the guidelines (e.g. more accurate description and scoring of corneal defects, additional axamination of aqueosus humor) do not affect the validity of this study

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black BD:1-Similar Substance 01 (A)

Molecular formula:

N/A

IUPAC Name:

Acid Black BD:1-Similar Substance 01 (A)

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna U.K. Ltd. England
- Number of animals: 3
- Female: nulliparus and nonpregnant
- Weight of animals: 3.6 Kg, 3.7 Kg and 4.0 Kg (before the application)
- Randomization: by a number generator software
- Identification: ear marks (tatoo) and cage cards
- Preventive treatment: no vaccinationsor treatment with antibiotics
- Housing: individual stainless steel cages with flat rod bases or plastic cages with perforated bases. xcrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spezialdiaten GmbH, Soest). Bedding was regularly spot-checked for contaminants and changed at least twice weekly.
- Diet: ad libitum, Standard diets "Ssniff K 4", (Ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water; ad libitum.
- Analytical check of nutritive composition, contaminan-contant and water for bacteria and contaminants was performed regularly.
- Acclimation period: at least 14 days. During this per id pooled faeces specimens were examined for Coccidia oocysts.
- Observation of animals: daily

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 %
- Air changes (per hr):a air-conditioned room, filtered
- Photoperiod (hrs dark / hrs light): 12 hours per day
- Irradiance. 27 Watt/m^2
- Air exchange: 10 times/hour
The humidity and air temperature were continuously recorded using a calibrated thermohygrograph (type 252, Lambrecht Co.,Gottingen).
- Cleanings: at least once per month, except for the room floor which was cleaned once per week, and disinfected with Zephirol® 10% (1% in water).
The drinking apparatus was cleaned once a week.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount: 500 mg moistured with water

VEHICLE
- Water, to prepare a paste with the test sample for the topical application

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 female

Details on study design:

TEST SITE
- Area of exposure: 6 cm^2 square
- Preparation: approximately 24 hours before the test, fur was shorn from the dorso-lateral area of the trunk of each of rabbits with an electric hair clipper
- Type of wrap if used: hypoallergenic Hansamed® - patch (Baiersdorf no. 2342 PV3)
- Semiocclusive dressing: Fixomull® Stretch Klebevlies, Beiersdorf no. 229

REMOVAL OF TEST SUBSTANCE
- Washing : with water without altering the existing response or the integrity of the epidermis

SCORING SYSTEM:
DRAIZE method, and any serious lesions or toxic effects other than dermal irritation, were also recorded.
Erythem and Eschar Formation value from 0 to 4
Oedema Formation value from 0 to 4
at 24, 48 and 72 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No dermal effects

Results 2

Irritation parameter:

edema score

Basis:

animal: all

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: No dermal effects

Irritant / corrosive response data:

Non irritant

Any other information on results incl. tables

animal n.	body weight (kg)	sex	DRAIZE Grade after										irritation index
			1 h		24 h		48 h		72 h		7 d
			E	O	E	O	E	O	E	O	E	O	E	O
D40	3.8	♀	0	0	0	0	0	0	0	0	0	0	0.0	0.0
D39	3.5	♀	0	0	0	0	0	0	0	0	0	0	0.0	0.0
D12	3.6	♀	0	0	0	0	0	0	0	0	0	0	0.0	0.0

E = Erythema

O = Oedema

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The substance is not irritant to the skin.

Executive summary:

Method

The substance has been tested according to the OECD Guidelines 405 with slight modifications which do not affect the validity of the test. Moreovere the test has been conducted in compliance with the GLP Regulation.

Results

No dermal effects have been observed during the 7 days of the observation period, therefore in the test condition the substance has to be considered as not irritant for skin.