Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)

Deviations:

no

Principles of method if other than guideline:

As compared to current guidelines deviations are: 24 h treatment and occlusive coverage, instead of 4 h treatment and semi-occlusive coverage. Mean scores for each animal were claculated from the readings 0, 24, and 48 h after the end of treatment.

Since test conditions were more stringent than required by OECD TG 404 test results are considered adequate to fulfill the endpoint requirements.

GLP compliance:

no

Remarks:

not established at that time

Test material

Test material information

Constituent 1

Reference substance name:

Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

EC Number:

256-050-0

EC Name:

Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]

Cas Number:

43035-18-3

Molecular formula:

C32H26N4O7S.1/2Ca

IUPAC Name:

calcium bis(4-{[3-({2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)-4-methylbenzoyl]amino}benzenesulfonate)

Test material form:

solid: nanoform, no surface treatment

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 1.5 - 2.5 kg
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped, partially scarified

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg pasted with 0.7 ml physiol. saline.

Duration of treatment / exposure:

24 h

Observation period:

48 h after end of exposure

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 1, 2, 3, 4, 5, 6 each

Time point:

other: mean of the 0, 24 and 48 h reading

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effect

Remarks on result:

other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.

Results 2

Irritation parameter:

edema score

Basis:

animal: # 1,2,3,5,6 each

Time point:

other: mean of the 0, 24 and 48 h reading

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effect

Remarks on result:

other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.

Results 3

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: mean of the 0, 24 and 48 h reading

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Scores of intact skin. Readings took place 0, 24 and 48 h after end of treatment. Means thereof were claculated for each rabbit.

Irritant / corrosive response data:

- Edema score for animal #1,2,3,4,5,6 immediately after removal of the test item (0 h): 0,0,0,1,0,0 and after 24 h: 0,0,0,1,0,0, and after 48 h: 0,0,0,0,0,0 (intact skin).

- At the scarified skin two animals showed erythema (score 1) 24 h after end of exposure, 3 animals showed edema at the end of the exposure period (score 1) and 1 animal showed edema score 1 at 24 h after end of exposure, these effects were completely reversible at the reading 48 h after end of exposure.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material is not irritating to skin. This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
1/6 animals showed a score of 1 for edema in the 24 h reading. This effect was completely reversible within 48 h after removal of the test item.

Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Only slight effects could be observed (1/6 animals showed a edema score of 1 in the 24 h reading, which was completely reversible in the 48 h reading.

No erythema effects could be observed in any animal.

Therefore, it is concluded that the test item is not irritating to skin.