Registration Dossier

Administrative data

Description of key information

Repeated dose toxicity: Oral

Data available for the read across chemicals was reviewed to determine the toxic nature of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine. The studies are as mentioned below:

Toxicity of the test chemical was assessed in Sprague Dawley rats in life time study. 30 Sprague Dawley rats per sex per dose group were fed the test chemical in diet at dose concentration of 0, 0.37, 1.39 or 5.19% (0, 180, 701,2829 mg/kg bw/day for males and 0, 228, 901, 3604 mg/kg bw/day for females), 1 wk before mating, throughout the 3-wk breeding period, and during the gestation and lactation periods. The animals were observed for clinical signs, mortality, morbidity, body weight and food consumption changes, hematology, clinical chemistry, gross and histopathology. No significant compound related adverse effect were observed on mortality, clinical signs, body weight (except for a reduction in body weight in high-dose 3604 mg/Kg bw/day females at the end of the study), food consumption, hematology, clinical chemistry, gross and histopathology. The no observed adverse-effect level (NOAEL) in this study was 5.19% (2829 mg/kg bw/day) for male rats, and 1.39% (901 mg/kg bw/day) for female rats.

13 weeks repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical The study was performed using 40 male and 40 female Sprague Dawley rats at dose levels of 0, 125, 250, 500 or 1000 mg/Kg/day. The post exposure study duration was 4 weeks. During the exposure period, the animals were observed for clinical signs, body weight changes and food consumption; ophthalmologic, hematological, clinical chemistry, urinanalysis was also performed. The animals were subjected to gross and histopathology. No relevant clinical symptoms and no signs of systemic toxicity were observed during the study. The eye examinations and urine analysis revealed no deviations from controls. The body weight gain and the absolute and relative organ weights were within the control ranges, with the exception of the females from the high dose group, which had higher kidney weights at the end of the treatment and the recovery period. The increased kidney weights were not associated with histopathological changes, and were unlikely to be of toxicological significance. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 500 mg/kg/day in male and female Sprague Dawley rats.

Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine is considered to be safe atleast in the dose range of 500 - 2829 mg/Kg/day. Hence the test chemical is not likely to be toxic as per the criteria mentioned in CLP regulatioin.

Repeated dose toxicity: Inhalation

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine has very low  vapor pressure (8.07E-012 Pa), so the potential for the generation of inhalable vapours is very low. Also 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 and therefore this end point was considered for waiver

Repeated dose toxicity: Dermal

The acute dermal toxicity value forN-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
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: Refer below principle
Principles of method if other than guideline:
WoE report is based on two chronic repeated dose toxicity study via oral route using rat,
1. Toxicity of the test chemical was assessed in Sprague Dawley rats in life time study
2. 13 weeks repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
No data
Sex:
male/female
Details on test animals and environmental conditions:
1. TEST ANIMALS
- Source: Charles River Breeding Laboratories. Inc., Wilmington, MA
- Age at study initiation: 90 days old approx.
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: rats were housed individually in stainless-steel cages except during the mating, lactation and post-weaning periods of the in utero phase
- Diet (e.g. ad libitum): Control animals received Purina Laboratory Chow and the treated animals received the appropriate dietary admixture
- Water (e.g. ad libitum): No data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 40-60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle

IN-LIFE DATES: From: To: No data

2. No data
Route of administration:
other: 1. Feed anf 2. Gavage
Details on route of administration:
No data
Vehicle:
other: Purina Laboratory Chow
Details on oral exposure:
1. PREPARATION OF DOSING SOLUTIONS: The test material was incorporated into the basal diet using a Patterson-Kelley twin shell blender and used at dose levels of 0.0, 0.37, 1.39 and 5.19% (0, 180, 701, 2829 mg/kg bw/day males and 0, 228, 901, 3604 mg/kg bw/day for females)

DIET PREPARATION
- Rate of preparation of diet (frequency): Fresh diets were prepared and presented weekly.
- Mixing appropriate amounts with (Type of food): Purina
Laboratory Chow
- Storage temperature of food: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): Purina Laboratory Chow
- Concentration in vehicle: 0.0, 0.37, 1.39 and 5.19% (0, 180, 701, 2829 mg/kg bw/day males and 0, 228, 901, 3604 mg/kg bw/day for females)
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data

2. PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with 1% carboxymethyl cellulose at dose levels of 0, 125, 250, 500, 1000 mg/kg/day

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): 1% caboxymethyl cellulose
- Concentration in vehicle: 0, 125, 250, 500, 1000 mg/kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data

Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
1.
Males: 118 weeks
Females: 121 weeks

2. 13 weeks
Frequency of treatment:
1. 1 wk before mating, throughout the 3-wk breeding period, and during the gestation and lactation periods
2. Daily
Remarks:
1. Males: 0.0, 0.37, 1.39 and 5.19% (0, 180, 701, 2829 mg/kg bw/day)
Females: 0.0, 0.37, 1.39 and 5.19% (0, 228, 901, 3604 mg/kg bw/day)
Basis: nominal in diet
Remarks:
2. 0, 125, 250, 500, 1000 mg/kg/day
No. of animals per sex per dose:
1. 30/sex/group
2. 220 animals (40/dose)
Control animals:
yes, concurrent vehicle
Details on study design:
1. The dietary concentrations for this study were selected based on the results of previous subchronic studies in rats
2. No data
Positive control:
No data
Observations and examinations performed and frequency:
1. CAGE SIDE OBSERVATIONS: Yes
- Time schedule: gross signs of toxicity, death and morbidity were recorded daily. The rats were observed twice daily (5 days/wk) during the last 6 months of the study to minimize the loss of tissue to autolysis in rats that died on test.

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly for wk 0 10, bi-weekly for wk 12-26, and every 4 wk thereafter

BODY WEIGHT: Yes
- Time schedule for examinations: weekly for wk 0 10, bi-weekly for wk 12 26, and every 4 wk thereafter

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):Yes weekly for wk 0 10, bi-weekly for wk 12 26, and every 4 wk thereafter

FOOD EFFICIENCY: No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples were obtained from the tail vein during the study, and from the abdominal aorta at termination test were conducted at wk 13, 26, 52 and 78 and at termination
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: five rats/sex/group
- Parameters checked : haematocrit, haemoglobin, erythrocyte count, and total and differential leucocyte counts.

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Blood samples were obtained from the tail vein during the study, and from the abdominal aorta at termination and clinical chemistry studies were performed on at week 52 and at termination
- Animals fasted: No data
- How many animals: 5 rats/sex/group
- Parameters checked: aspartate aminotransferase, Alanine aminotransferase, alkaline phosphatase, blood urea nitrogen, fasting glucose, total protein, sodium, potassium, chloride, carbon dioxide (termination only) and serum electrophoresis

URINALYSIS: Yes
- Time schedule for collection of urine: Urine samples were obtained by housing rats overnight in individual metabolism cages. Urinary analysis was conducted at wk 13, 26, 52, 78 and at termination
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No data
- Parameters checked : specific gravity, pH, glucose, ketones, total protein, bilirubin and sediment.

NEUROBEHAVIOURAL EXAMINATION: No data

OTHER:

2. CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included. Clinical symptoms

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily for systemic toxicity

BODY WEIGHT: Yes
- Time schedule for examinations: Weekly

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified

OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: weeks 0, 6, 13, and 17
- Dose groups that were examined: control and high-dose group animals

HAEMATOLOGY: Yes
- Time schedule for collection of blood: Weeks 0, 4, 12, and 17
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: control and high-dose group animals
- Parameters checked in table [No.?] were examined. Not specified

CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood: weeks 4, 12, and 17
- Animals fasted: Not specified
- How many animals: control and high-dose group animals
- Parameters checked in table [No.?] were examined. Not specified

URINALYSIS: Yes
- Time schedule for collection of urine: weeks 4, 12, and 17
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. Not specified

NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified

IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined. Not specified

OTHER: Not specified

Sacrifice and pathology:
1. GROSS PATHOLOGY: Yes
Gross autopsies were conducted on all rats that died spontaneously, were killed in a moribund condition, or were killed at the end of the study. Rats were killed by exsanguination under sodium pentobarbital. Absolute and relative organ weights were determined for the heart, liver, spleen, kidneys, testes with epididymides, and thyroid and adrenal glands.

HISTOPATHOLOGY: Yes
Complete histology was conducted on all rats from the control and high-dose groups. The following tissues from these rats were examined histologically: brain, pituitary, thoracic spinal cord, eyes, oesophagus, thyroid, thymus, heart, lungs, liver, spleen, pancreas, stomach, small and large intestine, mesenteric lymph node, kidneys, adrenal, urinary bladder, uterus, prostate, ovaries, testes with epididymides, seminal vesicles, skin, rib junction, bone marrow, nerve with muscle, and any tissue masses or lesions. Histology was also conducted on animals from any group with grossly observed masses or lesions. If a potential effect was consistently noted in a tissue then that tissue was examined histologically in all rats. All excised tissues not exhausted for histology were preserved.

2. GROSS PATHOLOGY: Yes, Following final treatment, animals were sacrificed, and organs and tissues were examined macroscopically

HISTOPATHOLOGY: Yes, Following final treatment, animals were sacrificed, and organs and tissues were examined microscopically

Statistics:
Gain in group mean body weight and total food consumption for weeks 0-54, group mean body weight at termination, and absolute and relative organ weights were analysed by the methods of Bartlett (937), Snedecor and Cochran (1967) and Scheffe (1953). Survival data were analysed by the methods of Sachs (1959) and Snedecor and Cochran (1967). Tumour incidence data were analysed by the methods described by Thomas et al. (1977). All analyses were considered
significant at P <0.05. Time-to-tumour analyses were not performed because data correlating the time of tumour development to the time of death were not
generated.
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Other effects:
not specified
Details on results:
1. CLINICAL SIGNS AND MORTALITY
There were no compound-related effects on survival
Localized hair loss (apparently due to friction against the cage) and nasal and ocular discharge occurred at low incidences throughout the study in control and treated rats. A red tint to the fur was noted in treated rats, and the faeces of mid- and high-dose rats were red. Palpable masses were noted with equal incidences in the control and treated groups.

Survival at the end of the study was similar in control and treated groups

BODY WEIGHT AND WEIGHT GAIN
Group mean body weights at the end of the study were decreased in rats that received FD & C Red No. 40 except for the mid-dose 701 mg/Kg bw/day males, in which they were increased.The mean body weight of the high-dose 3604 mg/Kg bw/day females at the end of the study was significantly less than that of the controls.

FOOD CONSUMPTION
Food consumption were increased in 2829 mg/Kg bw/day foe males and 3604 mg/Kg bw/day for females in the treated group but not significantly so as compared to control

HAEMATOLOGY
Few of the hematological differed significantly between control and treated rats, and none of the differences were compound related.

CLINICAL CHEMISTRY
Few of the Clinical chemistry differed significantly between control and treated rats, and none of the differences were compound related.

URINALYSIS
Few of the urinanalysis differed significantly between control and treated rats, and none of the differences were compound related.

ORGAN WEIGHTS
No compound-related changes in organ weights, were noted in rats that died on test or that were killed in a moribund state or at the end of the study.

GROSS PATHOLOGY
No compound related adverse effect observed

HISTOPATHOLOGY:
Histological evaluation revealed a variety of lesions, including neoplasm, among the control and treated rats.
The lesions were present at similar incidences in control and treated rats and appeared to be spontaneous. None of the lesions were determined to be related to the administration of FD & C Red No. 40.

2. Clinical signs and mortality: No relevant clinical symptoms and no signs of systemic toxicity were observed during the study.

Body weight and weight gain: The body weight gain of treated animals were within the control ranges

Food consumption and compound intake: No data

Food efficiency: No data

Water consumption and compound intake: No data

Opthalmoscopic examination: Eye examination revealed no deviations from controls.

Haematology: No data

Clinical chemistry: No data

Urinanalysis: Urine analysis revealed no deviations from controls.

Neurobehaviour: No data

Organ weights: The absolute and relative organ weights were within the control ranges, with the exception of the females from the high dose group, which had higher kidney weights at the end of the treatment and the recovery period. The increased kidney weights were not associated with histopathological changes, and were unlikely to be of toxicological significance.

Gross pathology: No gross pathological findings were noted

Histopathology: No histopathological findings were noted
Dose descriptor:
NOAEL
Remarks:
RA 1
Effect level:
2 829 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No compound-related adverse effects were observed
Dose descriptor:
NOAEL
Remarks:
RA 1
Effect level:
901 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
body weight and weight gain
Dose descriptor:
NOAEL
Remarks:
RA 2
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No significant treatment related effects were noted at the mentioned dose level
Critical effects observed:
not specified
Conclusions:
N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine is considered to be safe atleast in the dose range of 500 - 2829 mg/Kg/day on the basis of read across chemicals studied. Hence the test chemical is not likely to be toxic as per the criteria mentioned in CLP regulatioin.
Executive summary:

Data available for the read across chemicals was reviewed to determine the toxic nature of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine. The studies are as mentioned below:

Toxicity of the test chemical was assessed in Sprague Dawley rats in life time study. 30 Sprague Dawley rats per sex per dose group were fed the test chemical in diet at dose concentration of 0, 0.37, 1.39 or 5.19% (0, 180, 701,2829 mg/kg bw/day for males and 0, 228, 901, 3604 mg/kg bw/day for females), 1 wk before mating, throughout the 3-wk breeding period, and during the gestation and lactation periods. The animals were observed for clinical signs, mortality, morbidity, body weight and food consumption changes, hematology, clinical chemistry, gross and histopathology. No significant compound related adverse effect were observed on mortality, clinical signs, body weight (except for a reduction in body weight in high-dose 3604 mg/Kg bw/day females at the end of the study), food consumption, hematology, clinical chemistry, gross and histopathology. The no observed adverse-effect level (NOAEL) in this study was 5.19% (2829 mg/kg bw/day) for male rats, and 1.39% (901 mg/kg bw/day) for female rats.

13 weeks repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical The study was performed using 40 male and 40 female Sprague Dawley rats at dose levels of 0, 125, 250, 500 or 1000 mg/Kg/day. The post exposure study duration was 4 weeks. During the exposure period, the animals were observed for clinical signs, body weight changes and food consumption; ophthalmologic, hematological, clinical chemistry, urinanalysis was also performed. The animals were subjected to gross and histopathology. No relevant clinical symptoms and no signs of systemic toxicity were observed during the study. The eye examinations and urine analysis revealed no deviations from controls. The body weight gain and the absolute and relative organ weights were within the control ranges, with the exception of the females from the high dose group, which had higher kidney weights at the end of the treatment and the recovery period. The increased kidney weights were not associated with histopathological changes, and were unlikely to be of toxicological significance. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 500 mg/kg/day in male and female Sprague Dawley rats.

Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine is considered to be safe atleast in the dose range of 500 - 2829 mg/Kg/day. Hence the test chemical is not likely to be toxic as per the criteria mentioned in CLP regulatioin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 829 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Data is from peer reviewed publication

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Waiver

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: dermal, other
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Waiver

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data from read across chemical have been reviewed to determine the toxic nature of N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl] azo] naphthalen-2-amine upon repeated exposure by oral route. The studies are as mentioned below:

Repeated dose toxicity: Oral

Toxicity of the test chemical was assessed in Sprague Dawley rats in life time study. 30 Sprague Dawley rats per sex per dose group were fed the test chemical in diet at dose concentration of 0, 0.37, 1.39 or 5.19% (0, 180, 701,2829 mg/kg bw/day for males and 0, 228, 901, 3604 mg/kg bw/day for females), 1 wk before mating, throughout the 3-wk breeding period, and during the gestation and lactation periods. The animals were observed for clinical signs, mortality, morbidity, body weight and food consumption changes, hematology, clinical chemistry, gross and histopathology. No significant compound related adverse effect were observed on mortality, clinical signs, body weight (except for a reduction in body weight in high-dose 3604 mg/Kg bw/day females at the end of the study), food consumption, hematology, clinical chemistry, gross and histopathology. The no observed adverse-effect level (NOAEL) in this study was 5.19% (2829 mg/kg bw/day) for male rats, and 1.39% (901 mg/kg bw/day) for female rats.

13 weeks repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical The study was performed using 40 male and 40 female Sprague Dawley rats at dose levels of 0, 125, 250, 500 or 1000 mg/Kg/day. The post exposure study duration was 4 weeks. During the exposure period, the animals were observed for clinical signs, body weight changes and food consumption; ophthalmologic, hematological, clinical chemistry, urinanalysis was also performed. The animals were subjected to gross and histopathology. No relevant clinical symptoms and no signs of systemic toxicity were observed during the study. The eye examinations and urine analysis revealed no deviations from controls. The body weight gain and the absolute and relative organ weights were within the control ranges, with the exception of the females from the high dose group, which had higher kidney weights at the end of the treatment and the recovery period. The increased kidney weights were not associated with histopathological changes, and were unlikely to be of toxicological significance. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 500 mg/kg/day in male and female Sprague Dawley rats.

Based on the data available for the read across chemicals, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo] phenyl]azo] naphthalen-2-amine is considered to be safe atleast in the dose range of 500 - 2829 mg/Kg/day. Hence the test chemical is not likely to be toxic as per the criteria mentioned in CLP regulatioin.

Repeated dose toxicity: Inhalation

N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine has very low  vapor pressure (8.07E-012 Pa), so the potential for the generation of inhalable vapours is very low. Also 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 and therefore this end point was considered for waiver

Repeated dose toxicity: Dermal

The acute dermal toxicity value forN-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine(as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver.

Based on the data available for the read across, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine does not exhibit toxic nature upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available for the target chemical and its read across, N-(2-ethylhexyl)-1-[[2-methyl-4-[(4-methylphenyl)azo]phenyl]azo]naphthalen-2-amine (CAS no 93964 -07 -9) does not exhibit toxic nature upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant as per the criteria mentioned in CLP regulation.