Registration Dossier
Registration Dossier
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EC number: 239-888-1 | CAS number: 15790-07-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15985:1.
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
Acute oral toxicity dose (LD50) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was determined by Sustainability Support Services (Europe) AB as >2000 mg/kg body weight.It was concluded that LD50 value is greater than 2000 mg/kg bw.Thus, acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when administered via oral route in wistar albino female rats falls into the “Category 5 (>2000-5000) and LD50 cutoff is 5000 mg/kg b.wt by Harmonized Classification (GHC).
Acute Inhalation toxicity:
Acute Inhalation toxicity dose (LC50) of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex was predicted based on OECD QSAR toolbox 1705.881mg/L air and 1456.383 mg/L and different studies available for the functionally similar read across substance Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl) azo]-2-naphthoate (CAS no: 5281-04-9) >1510 mg/m3 and Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate (CAS no: 5858-81-1) >1510 mg/m3. All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex can be classified as category V of acute inhalation toxicity.
Acute dermal toxicity:
Acute dermal toxicity dose (LD50) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was determined by Sustainability Support Services (Europe) AB as >2000 mg/kg body weight.It was concluded that LD50 value is greater than 2000 mg/kg bw.Thus, acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when applied by dermal route in wistar albino rats falls into the “Category 5 (>2000) by Harmonized Classification (GHC).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Acute Oral Toxicity of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. – 15790-07-5) in Wistar Albino Rats.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- Name - Aluminium, 6-hydroxy-5-{(4-sulfophenyl) azo}-2-Naphthalenesulfonic acid complex
InChI - 1S/C16H12N2O7S2.Al/c19-15-8-1-10-9-13(27(23,24)25)6-7-14(10)16(15)18-17-11-2-4-12(5-3-11)
26(20,21)22;/h1-9,19H,(H,20,21,22)(H,23,24,25);/q;+3/p-3/b18-17+;
Smiles - c12c(cc(S(=O)(=O)[O-])cc2)ccc(c1\N=N\c1ccc(S(=O)(=O)[O-])cc1)[O-].[Al+3]
Mol. formula: C16H9AlN2O7S2
Molecular Weight - 432.368 g/mole
Characteristics : Orange yellow powder
Source: Unique Chemicals & Allied Products - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute for Industrial Research & Toxicology
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 to 9 weeks
- Weight at study initiation: 200±20g
- Fasting period before study: Fasted overnight prior to treatment
- Housing:Groups of three animals of similar sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
- Diet (e.g. ad libitum): Pelleted feed
- Water (e.g. ad libitum):Aqua Guard filter water was kept in PVC bottles, ad libitum
- Acclimation period:One week in experimental room after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature between 22-25°C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
IN-LIFE DATES: From:18/03/2013 To:28/04/2013 - Route of administration:
- other: oral cannula
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/ml
- Amount of vehicle (if gavage):10 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:2000 mg/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Three (3 females)/step
- Control animals:
- yes
- Remarks:
- Group I: Dist. water, 10ml/kg body wt.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).Rats were observed for mortality at the time interval of 30 minutes, 1hr, 2hr, 4 hr, and 6hr time interval on the day of test compound administration and thereafter twice a day for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: The treated animals were closely observed for clinical signs of intoxication, first 4 hours and every 1 hrs interval for 24 hrs after dosing and thereafter twice a day for 14 days. All the rats were observed at least twice daily to observe any clinical signs or behavioral changes. The organ which showed gross pathological change during necropsy subjected for histopathological study. - Statistics:
- No data
- Preliminary study:
- No data
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at 2000 mg/kg body weight
- Clinical signs:
- other: At the dose level of 2000 mg/kg body weight did not produce any clinical signs of toxicity during the entire observation period.
- Gross pathology:
- No significant gross pathological changes related to compound toxicity were observed.
- Other findings:
- Skin and hair coat was observed wet.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when administered via oral route in wistar albino female rats falls into the “Category 5 (>2000-5000) and LD50 cutoff is 5000 mg/kg b.wt by Harmonized Classification (GHC).
- Executive summary:
The study now reported was designed and conducted to determine the acute oral toxicity profile of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) in wistar albino female rats. The study was conducted under the OECD Guideline-423 for testing of chemicals.The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition and divided into test compound and vehicle control group each having three animals. Initially, the test compound was mixed with distilled water and administered orally at the dose level of 2000 mg/kg body weight (dose volume 10ml/kg) to three female rats. However; vehicle control group treated with distilled water at the dose level of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication during first 4 hours of test compound administration. Thereafter, all the animals were observed periodically at 1 hour interval for 24 hrs and twice daily for a period of 14 days. The necropsy was performed on all animals at the termination of the study. The test compound did not produce any mortality at the dose level of 2000 mg/kg body weight during the entire observation period. Animals did not produce any clinical signs of toxicity during the entire observation period. Animals showed normal gain in body weight on day 7th and 14th as compared to control group.No significant gross pathological changes related to compound toxicity were observed.Skin and hair coat was observed wet. It was concluded that the test compoundAluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5)is non-toxic at the tested dose level 2000 mg/kg body weight. According to Globally Harmonized Classification System for Chemical Substances, it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000-5000) and LD50 cutoff is 5000 mg/kg b.wt.
Reference
TABLE – 2
SUMMARY OF BODY WEIGHT (GM)
Group |
Day 0 |
Day 7 |
% Gain/loss |
Day 14 |
% Gain/loss |
Group-I distilled water 10ml/kg |
201.4 |
208.9 |
3.72 |
214.4 |
6.45 |
Group-II 2000 mg/kg b. wt |
203.7 |
210.2 |
3.19 |
216.9 |
6.48 |
Group-III 2000 mg/kg b. wt |
200.2 |
209.2 |
4.49 |
215.7 |
7.74 |
TABLE – 3
CLINICAL SIGNS AND MORTALITY
Group: I (Vehicle Control) Dose: 10 ml/kg b.wt
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3
|
Clinical Signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 = No clinical sign (Normal)
+ = Clinical Sign
TABLE – 3 (Contd.)
CLINICAL SIGNS AND MORTALITY
Group: II Dose: 2000 mg/kg b. wt.
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical Signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
TABLE – 3 (Contd.)
CLINICAL SIGNS AND MORTALITY
Group: III Dose: 2000 mg/kg b.wt
FEMALE RATS
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
||||||||||||||||||
Day 0 |
DAY |
|||||||||||||||||||
Min |
Hour |
|||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Clinical Signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 = Normal
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
TABLE – 4
SUMMARY OF NECROPSY FINDINGS
S. No. |
Fate
|
Wistar albino rats |
||
Dose (mg/kg b. wt) |
||||
Distilled water (10 ml/kg) |
2000
|
2000
|
||
1 |
Terminal sacrifice |
3/3 |
3/3 |
3/3 |
2 |
Found Dead |
0/3 |
0/3 |
0/3 |
3 |
Abnormalities detected |
NAD |
NAD |
NAD |
NAD - No abnormality recorded
TABLE - 5
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: I (Vehicle Control) Dose: 10 ml/kg b.wt
FEMALE RATS
Animal ID |
Fate |
Time |
Gross Findings |
201303-1 |
TS |
Day 15 |
NAD |
201303-2 |
TS |
Day 15 |
NAD |
201303-3 |
TS |
Day 15 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
TABLE – 5 Contd……..
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: II Dose: 2000 mg/kg b.wt.
FEMALE RATS
Animal ID |
Fate |
Time |
Gross Findings |
201303-4 |
TS |
Day 15 |
NAD |
201303-5 |
TS |
Day 15 |
NAD |
201303-6 |
TS |
Day 15 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD- Found Dead
TABLE – 5 contd……….
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: III Dose: 2000 mg/kg b.wt.
FEMALE RATS
Animal ID |
Fate |
Time |
Gross Findings |
201303-7 |
TS |
Day 15 |
NAD |
201303-8 |
TS |
Day 15 |
NAD |
201303-9 |
TS |
Day 15 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD- Found Dead
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
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: Estimated data
- GLP compliance:
- no
- Test type:
- other: Acute Rodent Inhalation Toxicity Test
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male
- Route of administration:
- inhalation
- Type of inhalation exposure:
- other: Inhalation: Vapor
- Vehicle:
- not specified
- Duration of exposure:
- 8 h
- No. of animals per sex per dose:
- 5-6 animals
- Control animals:
- not specified
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 1 456.383 other: mg/l
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The 8hr.acute inhalation median lethal concentration (LC50) of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex in Long-Evans male rat was found to be 1456.383 mg/l. Acute inhalation toxicity of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalation route.
- Executive summary:
The 8hr.acute inhalation median lethal concentration (LC50) of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex in Long-Evans male rat was found to be 1456.383 mg/l. Acute inhalation toxicity of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalation route.
Reference
The prediction was based on dataset comprised from the following descriptors: LC50
Estimation method: Taking average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
(("a" and "b" ) and ("c" and "d" ) )
Domain logical expression index: "a"
Referential boundary: The target chemical should be classified as High (Class III) by Toxic hazard classification by Cramer (original)
Domain logical expression index: "b"
Similarity boundary:Target: c1(O)(.[Al]{3+})c(N=Nc2ccc(S(=O)(=O)O)cc2)c2c(cc(S(=O)(=O)O)cc2)cc1
Threshold=10%,
Dice(Atom pairs)
Domain logical expression index: "c"
Parametric boundary:The target chemical should have a value of log Kow which is >= 0.451
Domain logical expression index: "d"
Parametric boundary:The target chemical should have a value of log Kow which is <= 1.61
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 705.881 mg/m³ air
- Quality of whole database:
- The data is K2 level as the data has been obtained from QSAR model considered by OECD.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute Dermal Toxicity of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. – 15790-07-5) in Wistar Albino Rats.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- yes
- Specific details on test material used for the study:
- Name - Aluminium, 6-hydroxy-5-{(4-sulfophenyl) azo}-2-Naphthalenesulfonic acid complex
InChI - 1S/C16H12N2O7S2.Al/c19-15-8-1-10-9-13(27(23,24)25)6-7-14(10)16(15)18-17-11-2-4-12(5-3-11)
26(20,21)22;/h1-9,19H,(H,20,21,22)(H,23,24,25);/q;+3/p-3/b18-17+;
Smiles - c12c(cc(S(=O)(=O)[O-])cc2)ccc(c1\N=N\c1ccc(S(=O)(=O)[O-])cc1)[O-].[Al+3]
Mol. formula: C16H9AlN2O7S2
Molecular Weight - 432.368 g/mole
Characteristics : Orange yellow powder
Source: Unique Chemicals & Allied Products - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute for Industrial Research & Toxicology, Ghaziabad
- Females (if applicable) nulliparous and non-pregnant: No
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 200±20g
- Fasting period before study: No data
- Housing:Groups of 2 animals of similar sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
- Diet (e.g. ad libitum): Pelleted feed
- Water (e.g. ad libitum): Fresh and clean water filered through 'Aqua Guard on line water filter', was kept in glass bottles, ad libitum
- Acclimation period: The healthy Wistar albino rats selected for study accliatized to standard laboratory condition for period of one week under close veterinary supervision.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature between 22-25°C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12
hours dark.
IN-LIFE DATES: From:18/03/2013 To:28/04/2013 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back skin of total body surface area
- % coverage: 10%
- Type of wrap if used: The test compound held in contact with an impervious dressing secured in place with an adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
- Time after start of exposure: 24 Hours - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Total = 20
Group I - 2000 mg/kg - 10 (5 male and Female)
Group II - 2000 mg/kg - 10 (5 male and Female) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).Rats were observed for mortality at 30 minutes time interval for first 6 hous on the day of test compund and therafter twice a day for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: The treated animals were closely observed for clinical signs of in toxication, first 4 hours and every 1 hrs interval for 24 hrs after dosing and thereafter twice a day for 14 days. All the rats were observed at least twice daily with the purpose of recording any symptoms of ill-health or behavioral changes. The organ which showed gross pathological change during necropsy subjected for histopathological study. - 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:
- No mortality was observed at 2000 mg/kg bw
- Clinical signs:
- other: Animals did not produce any clinical signs of intoxication throughout the period of observation.
- Gross pathology:
- No significant gross pathological changes related to compound toxicity were observed.
- Other findings:
- Skin and hair coat was observed wet.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute dermal LD50 of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when applied by dermal route in wistar albino rats falls into the “Category 5 (>2000) by Harmonized Classification (GHC).
- Executive summary:
The study now reported was designed and conducted to determine the acute dermal toxicity profile of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) in wistar albino rats. The study was conducted under the OECD Guideline-402 for testing of chemicals. In limit test, healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization. Approximate 10% back skin of total body surface area was prepared 24 hrs prior to application of test compound. Test drug was applied dermally at the dose of 2000 mg/kg bw for each animal. The treated animals were observed for clinical signs of intoxication.The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment). The Necropsy was performed on all at the termination of the study. After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the limit test of the test compound. Rats were observed for mortality at 30 minutes time interval for first 6 hous on the day of test compund and therafter twice a day for 14 days.All the rats were observed at least twice daily with the purpose of recording any symptoms of ill-health or behavioral changes. The organ which showed gross pathological change during necropsy subjected for histopathological study.No mortality was observed at 2000 mg/kg bw. Animals did not produce any clinical signs of intoxication throughout the period of observation.Animals showed normal gain in body weight on day 7th and 14th as compared to control group.No significant gross pathological changes related to compound toxicity were observed.Skin and hair coat was observed wet. Therefore, it was concluded that the test compoundAluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5)is non-toxic at the tested dose level 2000 mg/kg body weight. According to Globally Harmonized Classification System for Chemical Substances, it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000).
Reference
TABLE – 2
SUMMARY OF BODY WEIGHT (GM)
Group |
Animal ID |
Day 0 |
Day 7 |
% Gain/loss |
Day 14 |
% Gain/loss |
Group-I 2000 mg/kg b. wt |
201303-1 |
203.5 |
208.7 |
2.56 |
215.5 |
5.90 |
201303-2 |
202.6 |
209.3 |
3.30 |
215.8 |
6.51 |
|
201303-3 |
201.8 |
207.9 |
3.02 |
214.0 |
6.05 |
|
201303-4 |
204.2 |
210.4 |
3.04 |
217.2 |
8.13 |
|
201303-5 |
201.5 |
209.6 |
4.01 |
217.9 |
8.13 |
|
201303-6 |
201.6 |
208.3 |
3.32 |
216.8 |
7.54 |
|
201303-7 |
200.9 |
207.5 |
3.28 |
213.3 |
6.17 |
|
201303-8 |
200.2 |
207.1 |
3.45 |
216.5 |
8.14 |
|
201303-9 |
199.5 |
206.3 |
3.40 |
210.2 |
5.36 |
|
201303-10 |
201.7 |
209.6 |
3.92 |
217.7 |
7.93 |
|
Group-III 2000 mg/kg b. wt |
201303-11 |
199.8 |
207.3 |
3.75 |
214.3 |
7.25 |
201303-12 |
201.5 |
208.8 |
3.62 |
213.1 |
5.75 |
|
201303-13 |
198.8 |
206.5 |
3.87 |
214.6 |
7.95 |
|
201303-14 |
200 |
206.6 |
3.30 |
213.9 |
6.95 |
|
201303-15 |
203.5 |
209.2 |
2.80 |
216.4 |
6.34 |
|
201303-16 |
203.2 |
211.4 |
4.03 |
217.3 |
6.93 |
|
201303-17 |
201.3 |
208.4 |
3.52 |
216.7 |
7.65 |
|
201303-18 |
202.3 |
210.1 |
3.36 |
216.2 |
7.37 |
|
201303-19 |
200 |
206.6 |
3.30 |
214.2 |
7.10 |
|
201303-20 |
204.1 |
210.6 |
3.19 |
217.5 |
6.57 |
TABLE – 3
CLINICAL SIGNS AND MORTALITY
Group: I Limit Test Dose: 2000 mg/kg body weight
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
|||||||||||||||||||
Day 0 |
DAY |
||||||||||||||||||||
Min |
Hour |
||||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
% |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Clinical Signs - Local |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Redness |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Pain |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Swelling |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Systemic signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
- = Observed after 24 hrs
0 = No clinical sign (Normal)
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
TABLE – 3 Contd….
CLINICAL SIGNS AND MORTALITY
Group: II Confirmatory Test Dose: 2000 mg/kg body weight
Parameters |
Incidence of clinical signs observed after dosing |
Mortality |
|||||||||||||||||||
Day 0 |
DAY |
||||||||||||||||||||
Min |
Hour |
||||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total* |
% |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Clinical Signs - Local |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Redness |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Pain |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Swelling |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Systemic signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
- = Observed after 24 hrs
0 = No clinical sign (Normal)
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
TABLE – 4
SUMMARY OF NECROPSY FINDINGS
S. No. |
Fate
|
Wistar albino rats |
|
Dose (mg/kg b. wt) |
|||
2000 (Limit Test)
|
2000 (Confirmatory Test)
|
||
1 |
Terminal sacrifice |
10/10 |
10/10 |
2 |
Found Dead |
0/10 |
0/10 |
3 |
Abnormalities detected |
0/10 |
0/10 |
TABLE - 5
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: I (Limit Test) Dose: 2000 mg/kg bw |
|||
Animal ID |
Fate |
Time |
Gross Findings |
201303-1 |
TS |
Day 15 |
NAD |
201303-2 |
TS |
Day 15 |
NAD |
201303-3 |
TS |
Day 15 |
NAD |
201303-4 |
TS |
Day 15 |
NAD |
201303-5 |
TS |
Day 15 |
NAD |
201303-6 |
TS |
Day 15 |
NAD |
201303-7 |
TS |
Day 15 |
NAD |
201303-8 |
TS |
Day 15 |
NAD |
201303-9 |
TS |
Day 15 |
NAD |
201303-10 |
TS |
Day 15 |
NAD |
Group: I (Limit Test)Dose: 2000 mg/kg bw |
|||
201303-11 |
TS |
Day 15 |
NAD |
201303-12 |
TS |
Day 15 |
NAD |
201303-13 |
TS |
Day 15 |
NAD |
201303-14 |
TS |
Day 15 |
NAD |
201303-15 |
TS |
Day 15 |
NAD |
201303-16 |
TS |
Day 15 |
NAD |
201303-17 |
TS |
Day 15 |
NAD |
201303-18 |
TS |
Day 15 |
NAD |
201303-19 |
TS |
Day 15 |
NAD |
201303-20 |
TS |
Day 15 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD – Found dead
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
Additional information
Acute oral toxicity:
In an experimental study conducted by Sustainability Support Services (Europe) AB (study no.201303, 2013) was designed and conducted to determine the acute oral toxicity profile of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) in wistar albino female rats. The study was conducted under the OECD Guideline-423 for testing of chemicals.The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition and divided into test compound and vehicle control group each having three animals. Initially, the test compound was mixed with distilled water and administered orally at the dose level of 2000 mg/kg body weight (dose volume 10ml/kg) to three female rats. However; vehicle control group treated with distilled water at the dose level of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication during first 4 hours of test compound administration. Thereafter, all the animals were observed periodically at 1 hour interval for 24 hrs and twice daily for a period of 14 days. The necropsy was performed on all animals at the termination of the study. The test compound did not produce any mortality at the dose level of 2000 mg/kg body weight during the entire observation period. Animals did not produce any clinical signs of toxicity during the entire observation period. Animals showed normal gain in body weight on day 7th and 14th as compared to control group.No significant gross pathological changes related to compound toxicity were observed.Skin and hair coat was observed wet. It was concluded that the test compoundAluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5)is non-toxic at the tested dose level 2000 mg/kg body weight. According to Globally Harmonized Classification System for Chemical Substances, it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000-5000) and LD50 cutoff is 5000 mg/kg b.wt.
Acute Inhalation toxicity:
In different studies, Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) have been investigated for acute inhalation toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats and mice for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex along with the study available on the functionally similar read across substance Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl) azo]-2-naphthoate (CAS no: 5281-04-9) and Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate (CAS no: 5858-81-1). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies. The studies are summarized as below –
In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute inhalation toxicity was estimated for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex in Carworth Farms-Nelson male mouse was found to be 1705.881mg/l. Acute inhalation toxicity of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex to mouse by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalation route.
In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute inhalation toxicity was estimated for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex in Long-Evans male rat was found to be 1456.383 mg/l. Acute inhalation toxicity of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex to rat by inhalative route indicates that the substance does not exhibits acute toxicity by the inhalation route.
The above study is supported by IFA GESTIS, GESTIS SUBSTANCE Database (2017), for the functionally similar read across substance Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl) azo]-2-naphthoate (CAS no: 5281-04-9). The acute inhalation toxicity study was conducted in rat at the concentration of 1510 mg/m3. No mortality was observed at1510 mg/m3.Therefore, LC50 was considered to be >1510 mg/m3 when rat was treated with Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate by inhalation for 4 hours.
These results are further supported by GESTIS SUBSTANCE Database (2017), for the functionally similar read across substance Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate (CAS no: 5858-81-1). The acute inhalation toxicity study was conducted in rat at the concentration of 1510 mg/m3. No mortality was observed at1510 mg/m3.Therefore, LC50 was considered to be >1510 mg/m3 when rat was treated with Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate by inhalation for 4 hours.
Thus, based on the above studies on Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate (CAS no: 5858-81-1) and it’s read across substances, it can be concluded that LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate can be classified as category V of acute inhalation toxicity.
Acute dermal toxicity:
In a experimental study conducted by Sustainability Support Services (Europe) AB (report no.201303, 2013) was designed and conducted to determine the acute dermal toxicity profile of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) in wistar albino rats. The study was conducted under the OECD Guideline-402 for testing of chemicals. In limit test, healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization. Approximate 10% back skin of total body surface area was prepared 24 hrs prior to application of test compound. Test drug was applied dermally at the dose of 2000 mg/kg bw for each animal. The treated animals were observed for clinical signs of intoxication.The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment). The Necropsy was performed on all at the termination of the study. After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the limit test of the test compound. Rats were observed for mortality at 30 minutes time interval for first 6 hous on the day of test compund and therafter twice a day for 14 days.All the rats were observed at least twice daily with the purpose of recording any symptoms of ill-health or behavioral changes. The organ which showed gross pathological change during necropsy subjected for histopathological study.No mortality was observed at 2000 mg/kg bw. Animals did not produce any clinical signs of intoxication throughout the period of observation.Animals showed normal gain in body weight on day 7th and 14th as compared to control group.No significant gross pathological changes related to compound toxicity were observed.Skin and hair coat was observed wet. Therefore, it was concluded that the test compoundAluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5)is non-toxic at the tested dose level 2000 mg/kg body weight. According to Globally Harmonized Classification System for Chemical Substances, it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000).
Justification for classification or non-classification
Thus, based on the above studies and prediction on Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5), it can be concluded that LD50 value is greater than 2000 mg/kg bw for acute oral and dermal toxicity and the LC50 value is greater than 5 mg/L air for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex can be classified as category 5 for acute oral, dermal and inhalation toxicity.
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