4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

data is from experimental study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate

IUPAC Name:

Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphtalene-3,6-disulphonate

Test material form:

solid: particulate/powder

Details on test material:

Cas No: 3734-67-6
- Name of test material (IUPAC name): Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Common name: C.I. Acid Red 1
- Molecular formula: C18H13N3Na2O8S2
- Molecular weight: 509.426 g/mol
- Smiles notation: c12c(cc(S(=O)(=O)[O-])c(c2O)\N=N\c2ccccc2)cc(S(=O)(=O)[O-])cc1NC(C)=O.[Na+].[Na+]
-InChl:1S/C18H15N3O8S2.2Na/c1-10(22)19-14-9-13(30(24,25)26)7-11-8-15(31(27,28)29)17(18(23)16(11)14)21-20-12-5-3-2-4-6-12;;/h2-9,23H,1H3,(H,19,22)(H,24,25,26)(H,27,28,29);;/q;2*+1/p-2/b21-20+;;
- Substance type: Organic

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material: Sustainability Support Services (Europe) AB, Sweden
- Lot/batch No.of test material: 0009- Expiration date of the lot/batch: 4/7/2021
- Purity test date: No data available

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

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient Temperature
- Stability under test conditions: No data available
- Solubility and stability of the test substance in the solvent/vehicle: No data available
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data available

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 available
- Final dilution of a dissolved solid, stock liquid or gel: No data available
- Final preparation of a solid: No data available

FORM AS APPLIED IN THE TEST (if different from that of starting material) No data available
OTHER SPECIFICS:Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females (if applicable) nulliparous and non-pregnant: [no]
- 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 211.4 to 246.3 grams at initiation of dosing were used.
- Body weights at the start : Male Mean: 240.62 g (= 100 %) Minimum: 236.8 g (- 1.59 %) Maximum: 246.3 g (+ 2.36 %)
Total No. of animals : 5 Female Mean : 216.02 g (= 100 %) Minimum: 211.4 g (- 2.14 %) Maximum: 220.6 g (+ 2.12 %) Total No. of animals : 5
- Fasting period before study: No data available
- 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: No data available

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

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.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: No data available - For solids, paste formed: No data available

VEHICLE
- Amount(s) applied (volume or weight with unit):No data
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

total:10 animals
2000 mg/kg bw:5 males and 5 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance:Animals were observed for clinical signs, mortality, until sacrifice.Onset, duration and severity of any sign were recorded. The clinical signs and mortality 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. Daily observation was done as far as possible at the same time.The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern. Evaluation of Dermal Reaction:Dermal reaction was observed daily for study period of 14 days. Body weights:Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14. Gross Pathology:Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).

Statistics:

No data available

Results and discussion

Preliminary study:

no data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

Sex : Male
Group I - Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.
Sex : Female
Group I – Animal treated at the dose level of 2000 mg/kg: All animals survived through the study period of 14 days.

Clinical signs:

other: 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. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result i

Gross pathology:

Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.

Other findings:

- Other observations:Evaluation of Dermal Reaction
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.

Any other information on results incl. tables

Table No. I

 

Summary of Clinical Signs of Toxicity and Mortality

Test System : Sprague Dawley Rat

Sex : Male

Group  No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No clinical signs observed	5	1 - 5	Day 0 - Day 14	0/5

 

 

Sex : Female

Group  No.	Dose mg/kg	Observed Signs	Total Number of Animals	Animal Nos.	Period of signs in days  From - to	Mortality
I	2000	No clinical signs observed	5	6 - 10	Day 0 - Day 14	0/5

 

   

Table No. II

 

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.III

 

Mean Body Weight and Percent Body Weight Gain (g)

Test System : Sprague Dawley Rat

Sex : Male

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	240.62	261.48	8.65	284.90	8.96	18.38
		± SD	3.89	8.12	1.68	8.58	0.70	1.92

 

 

 

Sex : Female

Group No.	Dose (mg/kg body weight)		Body weight Day 0	Body weight Day 7	% body weight gain day 0-7	Body weight Day 14	% body weight gain day 7- 14	% body weight gain day 0- 14
I	2000	Mean	216.02	228.50	5.76	238.72	4.46	10.48
		± SD	3.57	6.69	1.39	8.08	0.65	1.96

 

Table No.IV

 

Summary of Gross Pathological Findings

Test System : Sprague Dawley Rat

 

Sex : Male

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	1 - 5	TS	No abnormality detected

 

Sex : Female

Group No.	Dose mg/kg	Animal Numbers	Animal Fate	Gross Pathological Findings
I	2000	6 - 10	TS	No abnormality detected

 TS = Terminal Sacrifice

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 value was considered to be >2000 mg/kg bw,when male and female Sprague Dawley rats were occlusively treated with Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (3734-67-6) by dermal application according to OECD Guideline 402 (Acute Dermal Toxicity).

Executive summary:

The acute dermal toxicity profile of Disodium 5-acetylamino-4-hydroxy-3-(phenyl azo)naphthalene-2,7-disulphonate(3734-67-6)in groups of 5 male and female Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity). 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. Hence,The LD50 value was considered to be >2000 mg/kg bw,whenmale and female Sprague Dawley rats were occlusively treated with Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate(3734-67-6) by dermal application according to OECD Guideline 402 (Acute Dermal Toxicity).