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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
To determine the acute dermal toxicity profile of the test chemical in Sprague Dawley rats.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate- Molecular formula: C20H14N2O7S2.2Na- Molecular weight : 502.4338 g/mol- Substance type: Organic- Physical state: Solid- Analytical purity: 98.04%
Specific details on test material used for the study:
- Name of test material (as cited in study report): Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate- Molecular formula: C20H14N2O7S2.2Na- Molecular weight : 502.4338 g/mol- Substance type: Organic- Physical state: Solid- Analytical purity: 98.04%SOURCE OF TEST MATERIAL- Source of test material: Sustainability Support Services (Europe) AB, Sweden - Lot/batch No.of test material: 0015- Expiration date of the lot/batch: 13 Feb.; 2021- Purity test date: No dataSTABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Ambient Temperature- Stability under test conditions: No data- Solubility and stability of the test substance in the solvent/vehicle: No data- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No dataTREATMENT OF TEST MATERIAL PRIOR TO TESTING- Treatment of test material prior to testing: Test item was moistened with distilled water before application.- Preliminary purification step (if any):No data- Final dilution of a dissolved solid, stock liquid or gel: No data- Final preparation of a solid: No dataFORM AS APPLIED IN THE TEST (if different from that of starting material) : No dataOTHER SPECIFICS:Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).

In vitro test system

Test system:
other: No data
Source species:
other: No data
Cell type:
other: No data
Cell source:
other: No data
Source strain:
other: No data
Details on animal used as source of test system:
No data
Justification for test system used:
No data
Vehicle:
other: No data
Details on test system:
No data
Control samples:
not specified
Amount/concentration applied:
No data
Duration of treatment / exposure:
No data
Duration of post-treatment incubation (if applicable):
No data
Number of replicates:
No data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
TEST ANIMALS - Source: National Institute of Biosciences, Pune. - Age at study initiation: Young adult male and female rats aged between 6 – 9 weeks were used. - Weight at study initiation: The weight ranges of approximately 210.2 to 245.4 grams at initiation of dosing were used. Body weights at the start : MaleMean : 240.40 g (= 100 %)Minimum : 234.6 g (- 2.41 %)Maximum : 245.4 g (+ 2.08 %)Total No. of animals : 5FemaleMean : 215.98 g (= 100 %)Minimum : 210.2 g (- 2.68 %)Maximum : 220.6 g (+ 2.14 %)Total No. of animals : 5- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding. - Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders. - Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use. - Acclimation period: 5 days. ENVIRONMENTAL CONDITIONS - Temperature (°C): Room temperature was maintained at 20.1 to 21.9 degree centigrade. - Humidity (%): Room humidity was maintained at 55.5% to 59.2%. - Air changes (per hr): The animal room was independently provided with at least ten to fifteen air changes per hour of 100% fresh air that had been passed through the HEPA filters. - Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room. IN-LIFE DATES: From: To: No data

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL - Amount(s) applied (volume or weight with unit): 2000 mg/kg bw- Concentration (if solution): no VEHICLE - Amount(s) applied (volume or weight with unit):No data - Concentration (if solution): No data - Lot/batch no. (if required): No data - Purity: No dataNEGATIVE CONTROL- Amount(s) applied (volume or weight): No data- Concentration (if solution): No dataPOSITIVE CONTROL- Amount(s) applied (volume or weight): No data- Concentration (if solution): No data
Duration of treatment / exposure:
24 hrs.
Observation period:
14 days
Number of animals:
10 (5/sex).
Details on study design:
TEST SITE - Area of exposure: Dorsal surface and sides from scapular to pelvic area. - % coverage: Approximately 10% of the total body surface area.- Type of wrap if used: Porous gauze dressing and non-irritating tape. REMOVAL OF TEST SUBSTANCE - Washing (if done): Distilled water was used to remove residual test item.OBSERVATION TIME POINTS(Indicate if minutes, hours or days): Observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day.SCORING SYSTEM: Draize Method.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal: 1 - 10
Time point:
other: 0 - 14 d
Score:
0
Reversibility:
other: no data
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Overall result:Sex : MaleGroup I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days. Sex : FemaleGroup I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Other effects:
Clinical Signs of Toxicity and Mortality Sex : MaleGroup I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.Sex : FemaleGroup I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.Body WeightSex : MaleGroup I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 8.88% and 18.87% respectively. Sex : FemaleGroup I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 4.29% and 9.60% respectively.Gross Pathological FindingsGross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.

Any other information on results incl. tables

Table No. I

 

Summary of Evaluation of Dermal Reaction

Test System : Sprague Dawley Rat

Sex : Male 

Group

 No.

Dose mg/kg

                          

Dermal Reaction

Total Number of

Animals

 

Animal Nos.

Period of signs in days

 From - to

 

Mortality

I

2000

No dermal reaction observed

5

1 - 5

Day 0 - Day 14

0/5

 

 

Sex : Female

 

Group

 No.

Dose mg/kg

                          

Dermal Reaction

Total Number of

Animals

 

Animal Nos.

Period of signs in days

 From - to

 

Mortality

I

2000

No dermal reaction observed

5

6 - 10

Day 0 - Day 14

0/5

 

 Table No. II

 

Individual Animal - Evaluation of Dermal Reaction

Test System : Sprague Dawley Rat

Sex : Male  

Group : I

Dose  : 2000 mg/kg body weight

Animal

Dermal

D A Y S

No.

Reaction

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

1

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

Sex : Female  

Group : I

Dose  : 2000 mg/kg body weight

Animal

Dermal

D A Y S

No.

Reaction

0

1

2

3

4

5

6

7

8

9

10

11

12

13

14

6

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

7

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

8

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

9

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

10

Erythema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Oedema

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Also, the erythema and edema score of rats was calculated as 0. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Thus it can be concluded that the test chemical can be considered to be not irritating to skin and classified under "Not Classified" category.
Executive summary:

A study was designed and conducted to determine the dermal reaction profile of the test chemical in Sprague Dawley rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures.Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study.

The animals were kept in their cages for at least 5 days prior to administration for acclimatization to the laboratory condition and after acclimatization period, animals were randomly selected. Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area. The test item was applied directly onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item. Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.

The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Also, the erythema and edema score of rats was calculated as 0. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.

Thus it can be concluded that the test chemical can be considered to be not irritating to skin and classified under "Not Classified" category.