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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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from experimental report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The study was conducted to determine the dermal reaction of Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex 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): aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Sustainability Support Services (Europe) AB
- Lot/batch No.of test material: FG/15-16/1018
- Expiration date of the lot/batch: June, 2023
- Purity test date: No data

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: No data
- Specific activity: No data
- Locations of the label: No data
- Expiration date of radiochemical substance: No data

STABILITY 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 data

TREATMENT 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 data

FORM AS APPLIED IN THE TEST (if different from that of starting material) : No data
OTHER 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:
other: No data
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 range of approximately 217.1 to 255.7 grams at initiation of dosing were used.
Body weights at the start :
Male
Mean : 246.04 g (= 100 %)
Minimum : 238.3 g (- 3.15 %)
Maximum : 255.7 g (+ 3.93 %)
Total No. of animals : 5
Female
Mean : 223.74 g (= 100 %)
Minimum : 217.1 g (- 2.97 %)
Maximum : 231.3 g (+ 3.38 %)
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 20.0 to 22.3 degree centigrade.
- Humidity (%): Room humidity was maintained at 55.7% to 59.6%.
- 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: No data

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): no

VEHICLE (not used)
- Amount(s) applied (volume or weight with unit):No data
- Concentration (if solution): No data
- Lot/batch no. (if required): No data
- Purity: No data

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data

POSITIVE 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.
- Time after start of exposure: 24 hours

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 vitro

Other effects / acceptance of results:
No data

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal: 1 - 10
Time point:
other: 0 - 14 d
Score:
0
Max. score:
0
Reversibility:
other: no data
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Overall result:
Sex : Male
Group 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 : Female
Group 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.

Results based on erythema and edema score:
Irritation parameter : erythema score
Basis : animal:1-5
Time point : other: 0 - 14 d
Score : 0
Max. score : 0
Reversibility: no data
Remarks on result : no indication of irritation

Irritation parameter : edema score
Basis : animal:1-5
Time point : other: 0 - 14 d
Score : 0
Max. score : 0
Reversibility: no data
Remarks on result : no indication of irritation

Irritation parameter : erythema score
Basis : animal: 6-10
Time point : other: 0 - 14 d
Score : 0
Max. score : 0
Reversibility: no data
Remarks on result : no indication of irritation

Irritation parameter : edema score
Basis : animal:6-10
Time point : other: 0 - 14 d
Score : 0
Max. score : 0
Reversibility: no data
Remarks on result : no indication of irritation
Other effects:
Clinical signs
Sex : Male
Group 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 : Female
Group 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 Weight
Sex : Male
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 10.18% and 19.28% respectively.

Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.60% and 11.43% respectively.

Mortality
Sex : Male
Group I - All animals survived through the study period of 14 days.

Sex : Female
Group I - All animals survived through the study period of 14 days.


Gross Pathological Findings
Gross 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

0 - 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

0 - 14

0/5

  

Table No.II

 

Individual Animal - Evaluation of Dermal Reaction

 

Laboratory Test Item Code :TAS/122/008

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:
The overall irritation score of the substance was obtained to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal. Hence, it was concluded that the substance ‘ Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)a zo]-2-naphthalenesulfonic acid complex’ is non-Irritating to the skin of rats under the experimental conditions tested .
Executive summary:

The study now reported was designed and conducted to determine the dermal reaction of Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex in Sprague Dawley rats.

The study now reported was designed and conducted to determine the dermal reaction of Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex in Sprague Dawley rats.

The test item 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. 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.

The overall irritation score of the substance was obtained to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal. Hence, it was concluded that the substance ‘Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)a zo]-2-naphthalenesulfonic acid complex’ is non-Irritating to the skin of rats under the experimental conditions tested .