5-acetamido-2-aminobenzenesulphonic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

data is from experimental reports following standard operating procedures

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To assess the dermal irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in accordance with OECD 404

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

EC Number:

254-879-2

EC Name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

Cas Number:

40306-75-0

Molecular formula:

C8H10N2O5S

IUPAC Name:

3-acetamido-5-amino-4-hydroxybenzenesulfonic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- Substance Type: Organic
- Physical State: Solid

Specific details on test material used for the study:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- Substance Type: Organic
- Physical State: Solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: female
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 1.90kg
- Housing:animals were housed individually in stainless steel cages provided with steel mesh bottom and facilities for food and water
- Diet (e.g. ad libitum): Pelleted feed supplied by Pranav Agro
- Water (e.g. ad libitum):Community tap water kept in glass bottles, ad libitum
- Acclimation period: The healthy rabbits selected for study were acclimatized to laboratory conditions one week prior to testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -25 deg C
- Humidity (%): 40-60%
- Air changes (per hr): air conditioned rooms with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 gm

Duration of treatment / exposure:

4 hours

Observation period:

1, 24,48 and 72 hours till 14 days after application

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage:approx 6 square cm
- Type of wrap if used: impervious dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after patch removal, the site of application was cleaned with luke warm water

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24,48 and 72 hours

SCORING SYSTEM: The intact skin site of application was observed for erythema and edema and scored according to Draize method.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test compound didnot produce any signs of irritation through out the observation period

Other effects:

The test compound did not produce any clinical signs of toxicity through out the study.

Any other information on results incl. tables

Individual Animal Dermal irritation scores

Rabbit number	Sex	Intact skin
		3 minutes		4 hours		24 hours		48 hours		72 hours		14 days
		Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythemea	Edema	Erythema	Edema
01	Female	0	0	0	0	0	0	0	0	0	0	0	0
02	Female	-	-	0	0	0	0	0	0	0	0	0	0
03	Female	-	-	0	0	0	0	0	0	0	0	0	0
Total		0	0	0	0	0	0	0	0	0	0	0	0
Mean		0	0	0	0	0	0	0	0	0	0	0	0
Grand total		0.0

 

Clinical signs

Sex	Rabbit number	Duration
		3 minutes	4 hours	24 hours	48 hours	72 hourss	14 days
Female	01	N	N	N	N	N	N
	02	N	N	N	N	N	N
	03	N	N	N	N	N	N

Where N-no clinical signs observed; C- Clinical signs observed

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce erythema or edema throughout the observation period of 14 days.The dermal irritation index was calculated to be 0.00. 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity through out the study.
Based on the score and observations, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be considered not irritating to skin and can be classified under the category 'Not Classified'.

Executive summary:

A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid.

3 female New Zealand White rabbits were used for the study. The animals were prepared 24 hrs prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 0.5 gm of the test compound was applied on a small area 6 square cms of the intact test site. Each site of application was covered with an impervious dressing which was secured with an adhesive tape. The animals were housed individually and restrained by the use of plastic collars. After patch removal [4 hours later] the unabsorbed test chemical was removed and the test site was washed with lukewarm water. The intact skin site of application was observed for erythema and edema at 1, 24,48 and 72 hours till 14 days after application and scored according to Draize method.

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce erythema or edema throughout the observation period of 14 days. The dermal irritation index was calculated to be 0.00. 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any clinical signs of toxicity throughout the study.

Based on the score and observations, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid can be considered not irritating to skin and can be classified under the category 'Not Classified'