Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study without GLP, but reporting the essential details of the study; poor substance characterisation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500. 41

Principles of method if other than guideline:

Primary irritation to the skin is measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5
milliliter (in case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire truni< of the animal is then wrapped with an impervious material such as rubberized cloth for the 24- hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)

EC Number:

275-864-7

EC Name:

Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)

Cas Number:

71701-15-0

Molecular formula:

C42H44CrN9O6

IUPAC Name:

Chromate(1-), bis[2-[2-[4,5-dihydro-3-methyl-5-(oxo-kO)-1-phenyl-1H-pyrazol-4-yl]diazenyl-kN1]benzoato(2-)-kO]-, hydrogen, compd. with 2-ethyl-1-hexanamine (1:1:1)

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped or abraded

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

3 days

Number of animals:

6

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h and 72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

none

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is considered to be "non-irritant" to rabbit skin according to the system of classification recommended by the ETAD Subcommittee for Toxicology

Executive summary:

EXPERIMENTAL PROCEDURE

The procedure employed was that prescribed by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500. 41.

On this occasion 0.5 g of the test item was mixed with 0.5 ml of distilled water before application to the skin.

RESULTS

None of the animals showed any observable response to treatment throughout the 72 hours observation period.

CONCLUSION

The test item is considered to be "non-irritant" to rabbit skin according to the system of classification recommended by the ETAD Subcommittee for Toxicology.