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Toxicological information

Skin irritation / corrosion

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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'