Registration Dossier

Administrative data

Description of key information

Acute oral Toxicity: 

The acute oral toxicity dose (LD50) for sodium naphthalene-1-sulfonate (130-14-3) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (130-14-3)cannot be classified for acute oral toxicity. 

Acute Inhalation Toxicity: 

Sodium naphthalene-1-sulphonate (CAS No. 130-14-3) has a particle size distribution to be in the range of 150 micron to 10 micron. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Therefore this end point for single dose toxicity by inhalation route is considered for waiver.

Acute dermal Toxicity: 

The acute dermal toxicity dose (LD50) for sodium naphthalene-1-sulfonate (130-14-3) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (130-14-3) cannot be classified for acute dermal toxicity. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Experimental data of read across substances
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two acute oral toxicity studies as- WoE-2 and WoE-3.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: sodium naphthalene-1-sulfonate
- Molecular formula: C10H7NaO3S
- Molecular weight: 230.218 g/mol
- Smiles notation: c12c(S(=O)(=O)[O-])cccc1cccc2.[Na+]
- InChl: 1S/C10H8O3S.Na/c11-14(12,13)10-7-3-5-8-4-1-2-6-9(8)10;/h1-7H,(H,11,12,13);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Species:
rat
Strain:
other: 1.not specified 2.Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
1.not specified
2.TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Female rats of the age of approximately 8 to 12 weeks old were used at the commencement of its dosing.
- Weight at study initiation: Body weight range was 197.5 to 210.4 grams.
Body weights at the start :
Female
Mean : 203.58 g (= 100 %)
Minimum : 197.5 g (- 2.99 %)
Maximum : 210.4 g (+ 3.35 %)
Total No. of animals : 12
- Identification: Each female rat was individually identified by the picric acid marking.
- Fasting period before study: Approximately 16 hours or more.
- Housing: The rats were housed in polycarbonate cages.
- 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): 20.1 to 21.9 degree centigrade.
- Humidity (%): 56.3% to 59.8%
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.

IN-LIFE DATES: 14-07-2017 to 02-08-2017
Route of administration:
other: 1.oral: unspecified 2.oral: gavage
Vehicle:
other: 1.not specified 2.corn oil
Details on oral exposure:
1.not specified
2.VEHICLE
- Concentration in vehicle: 300 mg/kg, 300 mg/kg, 2000 mg/kg and 2000 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
1.13900 mg/kg bw
2.Dose Group I : 300 mg/kg
Dose Group I : 300 mg/kg
Dose Group II : 2000 mg/kg
Dose Group II : 2000 mg/kg

No. of animals per sex per dose:
1.not specified
2.Three females were used at each step.
Control animals:
not specified
Details on study design:
1.not specified
2.- 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 and morbidity, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at immediately (0 to 5 minutes), 5, 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.

Body weights:
Individual animal body weights were recorded, before fasting, prior to administration of the test item (fasting body weights), weekly thereafter and at termination on day 14. Weight changes were calculated and recorded.

Gross Pathology:
Necropsy was performed on all animals at the end of the study period on day 15. 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.

Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
Statistics:
not specified
Preliminary study:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
13 900 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality was observed
Mortality:
1.50% mortality was observed at dose 13900 mg/kg bw
2.Group I
Step I :
Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.

Group I
Step II :
Animals treated at the dose level of 300 mg/kg body weight: All animals survived through the study period of 14 days.

Group II
Step I :
Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.

Group II
Step II :
Animals treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.
Clinical signs:
1.not specified
2.Group I
Step I :
Animals treated at the dose level of 300 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.
Group I
Step II :
Animals treated at the dose level of 300 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days.
Group II
Step I :
Animals treated at the dose level of 2000 mg/kg body weight resulted in polyurea, diarrhoea and ataxic gait with onset on day 2 after the dosing. All animals survived through the study period of 14 days and were free of signs of toxicity on day 3 after the dosing.

Group II
Step II :
Animals treated at the dose level of 2000 mg/kg body weight resulted in polyurea, diarrhoea and ataxic gait with onset on day 1 to day 2 after the dosing. All animals survived through the study period of 14 days and were free of signs of toxicity on day 4 after the dosing.
Body weight:
1.not specified
2.Group I
Step I (300 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 6.58% and 13.47% respectively.

Group I
Step II (300 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 6.31% and 12.98% respectively.

Group II
Step I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 4.22% and 11.34% respectively.

Group II
Step II (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 3.93% and 10.66% respectively.
Gross pathology:
1.not specified
2.Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.
Other findings:
not specified
Interpretation of results:
other: not classified
Conclusions:
According to CLP regulation, the test chemical sodium naphthalene-1-sulfonate (130-14-3) cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical sodium naphthalene-1-sulfonate (130-14-3).The studies are as mentioned below:

1.Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 13900 mg/kg bw. Hence,LD50 value was considered to be 13900 mg/kg bw,when rats were treated with test chemical orally.

2.The acute oral toxicity profile of test chemical in Sprague Dawley rats. Corn oil was used as vehicle.Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in polyurea, diarrhoea and ataxic gait with onset on day 2 after the dosing and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in polyurea, diarrhoea and ataxic gait with onset from day 1 to day 2 after the dosing and no mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. Hence,The lethal concentration (LD50) value for acute oral toxicity test was considered to be 5000mg/kg bw,when female Sprague Dawley rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

 

Thus, based on the above summarised studies, sodium naphthalene-1-sulfonate (130-14-3) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (130-14-3) cannot be classified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
13 900 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from authoritative database

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Quality of whole database:
Waiver

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Experimental data of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two acute dermal toxicity studies as- WoE-2 and WoE-3.
Acute dermal toxicity test was carried out to study the effects of the test chemicals on rodents
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: sodium naphthalene-1-sulfonate
- Molecular formula: C10H7NaO3S
- Molecular weight: 230.218 g/mol
- Smiles notation: c12c(S(=O)(=O)[O-])cccc1cccc2.[Na+]
- InChl: 1S/C10H8O3S.Na/c11-14(12,13)10-7-3-5-8-4-1-2-6-9(8)10;/h1-7H,(H,11,12,13);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Species:
other: 1.rat 2.rat
Strain:
other: 1.Sprague-Dawley 2.Wistar
Sex:
male/female
Details on test animals and environmental conditions:
1.TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks were used.
- Weight at study initiation: The weight range of approximately 222.8 to 255.5 grams at initiation of dosing.
Body weights at the start :
Male
Mean : 249.84 g (= 100 %)
Minimum : 244.7 g (- 2.06 %)
Maximum : 255.5 g (+ 2.27 %)
Total No. of animals : 5
Female
Mean : 226.06 g (= 100 %)
Minimum : 222.8 g (- 1.44 %)
Maximum : 230.6 g (+ 2.01 %)
Total No. of animals : 5
- Identification: Each rat was individually identified by the cage number.
- 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): 20.1 to 22.5 degree centigrade.
- Humidity (%): 53.2% to 58.8%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.

IN-LIFE DATES: 20-07-2017 to 04-08-2017

2.TEST ANIMALS
- Source: In-House Bred
- Age at study initiation: no data
- Weight at study initiation: Male: Minimum: 248 g and Maximum: 271 g
(Prior to Treatment) Female: Minimum: 202 g and Maximum: 249 g

- Fasting period before study: no data
- Housing:
Bedding : All cages were provided with corn cobs
Husbandry : The animals were housed individually in polycarbonate cages
Room Sanitation : The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
Cages and water bottle : All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): animals were provided conventional laboratory rodent diet ad libitum
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period: All animals were acclimatized to the test conditions for 6 days prior to administration of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 19.80 °C Maximum: 23.20 °C
- Humidity (%): Minimum: 50.60% Maximum: 63.20%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12


Type of coverage:
other: 1. semiocclusive 2.occlusive
Vehicle:
other: 1.distilled water 2.water
Details on dermal exposure:
1.TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the 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: Yes

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

2.TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: Approx. 10% of body surface area of rat
- Type of wrap if used: porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using distilled water
- Time after start of exposure: 24-hour exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2ml

Duration of exposure:
1.24 hours
2.24 hours
Doses:
1.A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
2.2000 mg/kg body weight
No. of animals per sex per dose:
1.10 (5/sex).
2.Five male and five female wistar rats
Control animals:
not specified
Details on study design:
1.- 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).

Histopathology:
No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.

2.- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology were observed
Statistics:
No data
Preliminary study:
No data
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:
1.Sex : Male
Group I -
Animal treated at the dose level of 2000 mg/kg body weight: 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: All animals survived through the study period of 14 days.

2.No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
Clinical signs:
1.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 in any signs of toxicity during the study period of 14 days.

2.All the animals were observed with normal clinical signs throughout the experimental period
Body weight:
1.Sex : Male
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 8.77% and 18.10% respectively.

Sex : Female
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 6.11% and 11.40% respectively.

2.Mean body weight of male and female was observed with increase on day 7 and 14, as compared to day 0
Gross pathology:
1.Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
2.The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
Other findings:
1- 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.

2.No data available
Interpretation of results:
other: not classified
Conclusions:
According to CLP regulation,the test chemical sodium naphthalene-1-sulfonate (CAS no.: 130-14-3) cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical sodium naphthalene-1-sulfonate (CAS no.: 130-14-3).The studies are as mentioned below:

1.The acute dermal toxicity profile of test chemical in Sprague Dawley rats. Distilled water was used as vehicle.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 ratswere semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).

2.Acute dermal toxicity study of test chemicalin Rats wasperformed as per OECD No. 402.Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.On test day 0, anamount oftestitem moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.After the 24-hour application period, the dressings were removed and theskin was gently wiped with distilled water.The skin reactions were assessed. All the animals were observed for mortality, clinical signs, body weight and gross pathology.No mortality were observedin any animal,normal clinical signs were observed.Mean body weight of male and female was observed with increase on day 7 and 14, as compared to day 0. Nopathological abnormality were observed. Thus theLD50 value was considered to be >2000 mg/kg bw,when male and female wistar rats were treated with test chemical by dermal application .

Thus, based on the above summarised studies, sodium naphthalene-1-sulfonate (CAS no.: 130-14-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (CAS no.: 130-14-3) cannot be classified for acute dermal toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from study report

Additional information

Acute oral Toxicity: 

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical sodium naphthalene-1-sulfonate (130-14-3).The studies are as mentioned below:

1.Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 13900 mg/kg bw. Hence,LD50 value was considered to be 13900 mg/kg bw,when rats were treated with test chemical orally.

2.The acute oral toxicity profile of test chemical in Sprague Dawley rats. Corn oil was used as vehicle.Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in polyurea, diarrhoea and ataxic gait with onset on day 2 after the dosing and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in polyurea, diarrhoea and ataxic gait with onset from day 1 to day 2 after the dosing and no mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. Hence,The lethal concentration (LD50) value for acute oral toxicity test was considered to be 5000mg/kg bw,when female Sprague Dawley rats were treated with test chemical orally via gavage according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Thus, based on the above summarised studies, sodium naphthalene-1-sulfonate (130-14-3) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (130-14-3) cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity: 

Sodium naphthalene-1-sulphonate (CAS No. 130-14-3) has a particle size distribution to be in the range of 150 micron to 10 micron. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Therefore this end point for single dose toxicity by inhalation route is considered for waiver.

Acute dermal Toxicity: 

Data available for the structurally similar read across chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical sodium naphthalene-1-sulfonate (CAS no.: 130-14-3).The studies are as mentioned below:

1.The acute dermal toxicity profile of test chemical in Sprague Dawley rats. Distilled water was used as vehicle.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 ratswere semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).

2.Acute dermal toxicity study of test chemicalin Rats wasperformed as per OECD No. 402.Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.On test day 0, anamount oftestitem moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.After the 24-hour application period, the dressings were removed and theskin was gently wiped with distilled water.The skin reactions were assessed. All the animals were observed for mortality, clinical signs, body weight and gross pathology.No mortality were observedin any animal,normal clinical signs were observed.Mean body weight of male and female was observed with increase on day 7 and 14, as compared to day 0. Nopathological abnormality were observed. Thus theLD50 value was considered to be >2000 mg/kg bw,when male and female wistar rats were treated with test chemical by dermal application .

Thus, based on the above summarised studies, sodium naphthalene-1-sulfonate (CAS no.: 130-14-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (CAS no.: 130-14-3) cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above experimental studies on sodium naphthalene-1-sulfonate (130-14-3)and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral and dermal toxicity.Thus, comparing this value with the criteria of CLP regulation,sodium naphthalene-1-sulfonate (130-14-3)cannot be classified for acute oral and dermal toxicity.For Acute inhalation toxicity wavier was added so, not possible to classify.