Registration Dossier

Administrative data

Description of key information

The chemical Solvent Blue 4 (α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (containing less than 0.1% Michler’s Ketone) was not found to exhibit acute toxicity by the oral, inhalation or dermal route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
The aim of this study was to assess the toxicity potential of α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (containing less than 0.1% Michler’s Ketone) Synonym Solvent Blue 4 (CAS No. – 6786-83-0) after single oral administration in rats and an observation period of 14 days.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation:8- 10 weeks at the time of dosing.
- Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation:Minimum: 131 g Maximum: 160 g (Individual body weights were within ± 7% prior to treatment after overnight fasting)
- Fasting period:were fasted for 16 to 18 hours, prior to dosing .
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 25/2014.
- 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):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004..
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period:Animal nos. 1-3 were acclimatized for 5 days and 4-6 for 11 days prior to administration of the test item..

ENVIRONMENTAL CONDITIONS
-Temperature : Minimum: 19.80°C Maximum: 23.20°C
-Relative humidity:Minimum: 48.70 % Maximum: 69.20 %
-Light-dark-rhythm:12:12
-Air Changes : More than 12 changes per hour


Route of administration:
oral: unspecified
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle:N/A
- Lot/batch no. (if required):N/A
- Purity:N/A

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

Doses:
G1 = 2000 mg/kg bw
No. of animals per sex per dose:
6 female rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
AAt the end of 14 day observation period, all surviving rats were euthanised by overdose of CO2 for external and internal observations.
- Other examinations performed:


Clinical Observation
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the six animals were observed once a day during the 14 day observation period.

Mortality
All the animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.

Body weight
All the rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.

Pathology
At the end of 14 day observation period, all surviving rats were euthanised by overdose of CO2 for external and internal observations

Sex:
female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed througout the experimentation period
Clinical signs:
At 2000mg/kg, animal no. 1 and 4 were observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours and on day 1 post dosing while additionally, animal no. 1 was observed with mild lethargy on day 2 and animal no. 4 was observed with mild diarrhea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 2 was observed with normal clinical signs at 30 minutes, mild lethargy at 1, 2, 3 and 4 hours and mild diarrhoea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 3 was observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours, day 1, 2 and 3 and mild diarrhoea at 2 hours, followed by normal clinical signs till day 14. Animal no. 5 was observed with mild lethargy at 30 minutes, 1, 2, 3 and 4 hours and mild diarrhoea at 1, 2, 3 and 4 hours, followed by normal clinical signs till day 14. Animal no. 6 was observed normal clinical signs at 30 minutes, 1, 2, 3 and 4 hours and mild lethargy on day 1 and 2, followed by normal clinical signs till day 14
Body weight:
Mean body weight of animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0
Gross pathology:
No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

Sex:Female

Animal No.

Group/ Dose (mg/kg)

Body Weight (gram)

Body Weight Change (%)

Day 0

Day 7

Day 14

Day

0-7

Day

0-14

1

G1/ 2000

135

160

177

18.52

31.11

2

146

180

199

23.29

36.30

3

137

143

172

4.38

25.55

4

147

166

182

12.93

23.81

5

160

190

206

18.75

28.75

6

131

161

183

22.90

39.69

Key:- = Not Applicable

 


Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)

Sex:Female

Group/ Dose (mg/kg)

Rats Body Weight (g)

Body Weight Changes (%)

Day 0

Day 7

Day 14

0-7

0-14

 

G1/ 2000

Mean

142.67

166.67

186.50

16.79

30.87

SD

10.56

16.49

13.19

7.15

6.17

n

6

6

6

6

6

Keys:SD = Standard Deviation, n = Number of Animals

Keys:- = Not applicable, 1 = Normal, 2 = Found dead, 4 = Abdominal breathing, 145 = Salivation,      155 = Sternal recumbency, 166 = Tremors, + = Mild, ++ = Moderate



Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 (cut-off value) of Solvent blue 4 (CAS No. – 6786-83-0) was greater than 2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Solvent blue 4 (CAS No.- 6786-83-0) does not exhibits acute oral toxicity in as per CLP criteria of classification
Executive summary:

Acute Oral Toxicity Study ofSolvent blue 4 (CAS No. – 6786-83-0)in Rats, This study was performed as per OECD No. 423.

Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. Hence, further dosing was stopped. Body weights were re­corded on day 0 (prior to dosing) 7 and 14. Mean body weight of all six animals was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, animal no. 1 and 4 were observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours and on day 1 post dosing while additionally, animal no. 1 was observed with mild lethargy on day 2 and animal no. 4 was observed with mild diarrhea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 2 was observed with normal clinical signs at 30 minutes, mild lethargy at 1, 2, 3 and 4 hours and mild diarrhoea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 3 was observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours, day 1, 2 and 3 and mild diarrhoea at 2 hours, followed by normal clinical signs till day 14. Animal no. 5 was observed with mild lethargy at 30 minutes, 1, 2, 3 and 4 hours and mild diarrhoea at 1, 2, 3 and 4 hours, followed by normal clinical signs till day 14. Animal no. 6 was observed normal clinical signs at 30 minutes, 1, 2, 3 and 4 hours and mild lethargy on day 1 and 2, followed by normal clinical signs till day 14

No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifce

Under the conditions of this; acute oral toxicity study of Solvent blue 4 (CAS No. – 6786-83-0) in female rats is as given below:The acute oralLD50(Cut-off value) of Solvent blue 4 (CAS No. – 6786-83-0)was greater than 2000 mg/kgbody weight

Solvent blue 4 (CAS No. – 6786-83-0) isbeing not classified as per CLP regulation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
K1 ranked experimental study from an OECD GLP laboratory.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The objective of the study was to assess the dermal toxicity of Solvent blue 4 (CAS No. – 6786-83-0) after single dose application by dermal route in rats and an observation period of 14 days.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:In-House Bred at Sa-Ford, Animal Facility.
- Age at study initiation:N/A
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight (Prior to Treatment)::Male:Minimum: 242 g and Maximum: 262 g (Prior to Treatment)Female:Minimum: 221 g and Maximum: 249 g
- Fasting period before study:N/A
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding : All cages were provided with corn cobs.
- 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):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) 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 5 days prior to administration of the test item.
- Randomization : Animals were selected manually. No computer generated randomization program was used

ENVIRONMENTAL CONDITIONS
-Temperature :Minimum: 19.80 °C Maximum: 23.20 °C
-Relative humidity:Minimum: 50.60% Maximum: 61.10%
-Light-dark-rhythm:12:12
-Air Changes :More than 12 changes per hour


Type of coverage:
other: porous gauze dressing covered with a non-irritating tape
Vehicle:
other: distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure:The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage:Approximately 10% body surface area of rat.
- Type of wrap if used:The porous gauze dressing and non-irritating tape.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A limit dose of 2000 mg/ kg body weight of test item was applied.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit):0.2 ml distilled water
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A
Duration of exposure:
24 hrs
Doses:
2000 mg/kg body weight.
No. of animals per sex per dose:
10 (Five per sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.
- Other examinations performed:
- Clinical signs : After test item administration, 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.

-Mortality
Animals were observed twice daily for any mortality during the experimental period

- Body weight: All rats were weighed on days 0 (prior to dosing), 7 and 14..

other:
-Pathology
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.
Statistics:
No statistical analysis was performed since the study was terminated with limit test.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Non toxic to animals
Mortality:
No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.
Clinical signs:
No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
Body weight:
In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. In females, mean body weight was observed with decrease on day 7 and increase on day 14, as compared to day 0
Gross pathology:
The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

 

Dose: 2000 mg/ kg bodyweight      

Animal No.

Sex

Body Weight (gram)

Body Weight Change (%)

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

1

Male

262

260

289

-0.76

10.31

2

242

258

281

6.61

16.12

3

251

269

300

7.17

19.52

4

260

271

302

4.23

16.15

5

258

274

310

6.20

20.16

6

Female

228

231

240

1.32

5.26

7

221

219

225

-0.90

1.81

8

249

241

246

-3.21

-1.20

9

224

216

218

-3.57

-2.68

10

230

231

240

0.43

4.35

                                                                                                   

Table 2: Individual Animal Clinical Signs and Symptoms

 

Dose: 2000 mg/kg body weight

Animal

No.

Sex

Hour(s) - Day 0

Day

1

2

3

4

1

2

3

4

5

6

7

1

Male

1

1

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

1

1

1

1

5

1

1

1

1

1

1

1

1

1

1

1

6

Female

1

1

1

1

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

1

1

1

1

8

1

1

1

1

1

1

1

1

1

1

1

9

1

1

1

1

1

1

1

1

1

1

1

10

1

1

1

1

1

1

1

1

1

1

1

Animal

No.

Sex

Day

8

9

10

11

12

13

14

1

Male

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

5

1

1

1

1

1

1

1

6

Female

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

8

1

1

1

1

1

1

1

9

1

1

1

1

1

1

1

10

1

1

1

1

1

1

1

Keys: 1 = Normal

Table 3: Individual Animal Mortality Record

 

Dose: 2000 mg/kg body weight

       Animal No.

Sex

Days of Observation (0 to 14)

Morning Observations

Evening Observations

1

Male

No mortality and morbidity

No mortality and morbidity

2

No mortality and morbidity

No mortality and morbidity

3

No mortality and morbidity

No mortality and morbidity

4

No mortality and morbidity

No mortality and morbidity

5

No mortality and morbidity

No mortality and morbidity

6

Female

No mortality and morbidity

No mortality and morbidity

7

No mortality and morbidity

No mortality and morbidity

8

No mortality and morbidity

No mortality and morbidity

9

No mortality and morbidity

No mortality and morbidity

10

No mortality and morbidity

No mortality and morbidity


Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose of Solvent blue 4 (CAS No. – 6786-83-0) was >2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Solvent blue 4 (CAS No. – 6786-83-0) does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.



Executive summary:

Acute Dermal Toxicity Study of “ Solvent blue 4 (CAS No. – 6786-83-0)” was studied in Wistar Rats, This study was performed 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. Ratsfree 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.

All the animals were observed with normal clinical signs throughout the experimental period .No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.

In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. In females, mean body weight was observed with decrease on day 7 and increase on day 14, as compared to day 0.The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality

Under the conditions of this; acute dermal toxicity study of Solvent blue 4 (CAS No. - 6786 -83 -0)in rats is as given below:

The acute dermal median lethal dose of Solvent blue 4 was >2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Solvent blue 4 does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
K1 ranked experimental study from an OECD GLP laboratory.

Additional information

Acute oral:

Acute Oral Toxicity Study of Solvent blue 4 (CAS No. – 6786-83-0) was performed in Rats, This study was performed as per OECD No. 423.Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. Hence, further dosing was stopped. Body weights were re­corded on day 0 (prior to dosing) 7 and 14. Mean body weight of all six animals was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, animal no. 1 and 4 were observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours and on day 1 post dosing while additionally, animal no. 1 was observed with mild lethargy on day 2 and animal no. 4 was observed with mild diarrhea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 2 was observed with normal clinical signs at 30 minutes, mild lethargy at 1, 2, 3 and 4 hours and mild diarrhoea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 3 was observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours, day 1, 2 and 3 and mild diarrhoea at 2 hours, followed by normal clinical signs till day 14. Animal no. 5 was observed with mild lethargy at 30 minutes, 1, 2, 3 and 4 hours and mild diarrhoea at 1, 2, 3 and 4 hours, followed by normal clinical signs till day 14. Animal no. 6 was observed normal clinical signs at 30 minutes, 1, 2, 3 and 4 hours and mild lethargy on day 1 and 2, followed by normal clinical signs till day 1No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifceUnder the conditions of this; acute oral toxicity study of Solvent blue 4 (CAS No. – 6786-83-0) in female rats is as given below:The acute oralLD50(Cut-off value) ofSolvent blue 4 (CAS No. – 6786-83-0) was 2000 mg/kgbody weight Solvent blue 4 (CAS No. – 6786-83-0) isbeing not classified as per CLP regulation. Acute Inhalation: In accordance with column 2 of Annex VIII, this end point was considered for waiver since exposure of humans via inhalation is unlikely taking into account the very low vapour pressure of α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4). The estimated vapor pressure value is 0.00000000000000267Pa at 25 deg C. Exposure to inhalable particulates is also unlikely given that the particle size distribution does not suggest nano sized particles. Thus, this exposure also stands negated and therefore based on exposure considerations; this end point was considered for waiver. Acute Dermal:

Acute Dermal Toxicity Study of “Solvent blue 4 (CAS No. – 6786-83-0)” was carried out in Wistar Rats, This study was performed 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. Ratsfree 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.

All the animals were observed with normal clinical signs throughout the experimental period .No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.

In males, mean body weight was observed with increase on day 7 and 14, as compared to day 0. In females, mean body weight was observed with decrease on day 7 and increase on day 14, as compared to day 0.The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality

Under the conditions of this; acute dermal toxicity study of Solvent blue 4(CAS No. - 6786 -83 -0)in rats is as given below:

The acute dermal median lethal dose ofSolvent blue 4was>2000 mg/kgbody weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers thatSolvent blue 4does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

 


Justification for selection of acute toxicity – oral endpoint
K1 ranked experimental study from an OECD GLP laboratory.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of Annex VIII, this end point was considered for waiver since exposure of humans via inhalation is unlikely taking into account the very low vapour pressure of α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (Solvent Blue 4). The estimated vapor pressure value is 0.00000000000000267Pa at 25 deg C.
Exposure to inhalable particulates is also unlikely given that the particle size distribution does not suggest nano sized particles. Thus, this exposure also stands negated and therefore based on exposure considerations; this end point was considered for waiver.

Justification for selection of acute toxicity – dermal endpoint
K1 ranked experimental study from an OECD GLP laboratory. The acute dermal median lethal dose of Solvent blue 4 (CAS No. – 6786-83-0) was >2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Solvent blue 4 (CAS No. – 6786-83-0) does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Justification for classification or non-classification

Based upon the data for the target chemical as well as using supporting study it can be concluded that Solvent Blue 4 is unlikely to be acutely toxic via the oral, inhalation and dermal route within the dose limits mentioned in the data end points. Thus, the chemical is not classified for Acute Toxicity by ay of the ruotes of exposure (Oral, Inhalation and Dermal).