Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 July 1989 - 7 July 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Adopted 12 may 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)

EC Number:

250-774-0

EC Name:

Hydrogen bis[1-[(5-chloro-2-hydroxyphenyl)azo]-2-naphtholato(2-)]chromate(1-)

Cas Number:

31714-55-3

Molecular formula:

C32H19Cl2CrN4O4

IUPAC Name:

[1-{[5-chloro-2-(hydroxy-kappaO)phenyl]diazenyl}-2-naphtholato(2-)-kappaO]{1-[(5-chloro-2-hydroxyphenyl)diazenyl]-2-naphtholato-kappaO}chromium

Test material form:

solid: particulate/powder

Details on test material:

Storage: ambient temperature in darkness
Appearance: Black powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino rabbit

Details on test animals or test system and environmental conditions:

- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 9 -11 weeks.
- Weight at study initiation: at least 2.1 - 2.4 kg
- Housing: Animals were housed individually in metal cages with perforated floors.
- Diet: Free access to SDS Standard Rabbit Diet
- Water: Free access to tap water.


ENVIRONMENTAL CONDITIONS
- Temperature: approx 19°C
- Humidity: between 30% - 70%
- Air changes (per hr): approx 19 air changes
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 4 july 1989 to 7 july 1989

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

Amount / concentration applied:

TEST MATERIAL
- Amount: 0.5 grams

Duration of treatment / exposure:

Single application.

Observation period:

4 days.

Number of animals:

2 females and 1 male.

Details on study design:

STUDY DESIGN


TEST SUBSTANCE PREPARATION
Used as recieved from sponsor

TEST SITE
Approximately 24 hours before application of the test substance, the dorsal-lumbar fur was removed with electric clippers, exposing an area of approximately 10x10 cm

0.5 g of bontron S-34 was applied under a 2.5 cm square gauze pad moistened with 0.5 ml distilled water to one intact skin site on each animal.
Eacht treamtent site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.

OBSERVATIONS
The treated skin was examined on day 1, approximately 30 mintues after removal of the patches and on days 2, 3 and 4.


SCORING SYSTEM: According to guideline.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There was no dermal response in any animal throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

An acute dermal irritation/corrosion study was performed following OECD 404 guidance. A single semi-occlusive application of Bontron S-34 to rabbit skin for four hours elicited no dermal response. Based on these results, it is concluded that Botron S-34 is not irritating to skin.

Executive summary:

Bontron S-34 was evaluated for dermal irritation on 2 female and 1 male New Zealand White rabbits according to OECD test guideline 404 and GLP principles.

A single dose of 0.5 test item was applied on electrical clipped skin under a gauze pad moistened with 0.5 ml distilled water and held there for 4 hours. Oberservations took place 30 mins after removal of the gauze pad and on the next three consequetive days. No dermal response was observed in any animal throughout the observation period. Based on these results, it can be concluded that Botron S-34 is not irritating and not classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).