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EC number: 229-246-9 | CAS number: 6448-96-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- 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 from secondary source
Data source
Reference
- Reference Type:
- other: authoritative database
- Title:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) of 2-Naphthalenecarboxamide,3-hydroxy-N-phenyl in rats
- Author:
- National Institute of Health Sciences
- Year:
- 2 018
- Bibliographic source:
- Japan Chemicals Collaborative Knowledge Database, 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) of test chemical in rats
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data avaiable
Test material
- Reference substance name:
- 92-77-3
- IUPAC Name:
- 92-77-3
- Reference substance name:
- 2-Naphthalenecarboxamide,3-hydroxy-N-phenyl
- IUPAC Name:
- 2-Naphthalenecarboxamide,3-hydroxy-N-phenyl
- Reference substance name:
- 3-hydroxy-2-naphthanilide
- EC Number:
- 202-188-1
- EC Name:
- 3-hydroxy-2-naphthanilide
- Cas Number:
- 92-77-3
- Molecular formula:
- C17H13NO2
- IUPAC Name:
- 3-hydroxy-2-naphthanilide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):2-Naphthalenecarboxamide,3-hydroxy-N-phenyl
- Molecular formula: C17H13NO2
- Molecular weight : 263.29 g/mole
- Substance type: Organic
- Physical state:Smoky and very light yellow powder
- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- No data avaiable
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:9 weeks old
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: 1 w/v% Tween 80 solution
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material dissolved in 1 w/v% Tween 80 solution
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 40, 200, 1000 mg/kg
- Amount of vehicle (if gavage):
- Lot/batch no. (if required):
- Purity: - Details on mating procedure:
- No data avaiable
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data avaiable
- Duration of treatment / exposure:
- Male: 42 days
Female: 42 – 48 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily
- Details on study schedule:
- Recovery period: Males, 14 days
Females (satellite), 14 days
Sacrifice : Males, day 43 of treatment and day 15 of recovery
Females, day 5 of lactation
Females (satellite), day 15 of recovery
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- No of animals Total: 116
0 mg/kg bw/day:12 male , 12 female
40 mg/kg bw/day:12 male , 12 female
200 mg/kg bw/day:12 male , 12 female
1000 mg/kg bw/day:12 male , 12 female
Recovery:
0 mg/kg bw/day: 5 male , 5 female
1000 mg/kg bw/day: 5 male , 5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data avaialble
- Positive control:
- No data avaialble
Examinations
- Parental animals: Observations and examinations:
- Clinical signs, FOB, Body weight, Food consumption, Urinalysis, Hematology and clinical chemistry were observed.
- Oestrous cyclicity (parental animals):
- Estrous cycle, numbers of corpora lutea or Implantations were observed
- Sperm parameters (parental animals):
- No data avaialble
- Litter observations:
- Viability, Clinical signs and Body weight were observed
- Postmortem examinations (parental animals):
- Gross pathology and Histopathology were observed
- Postmortem examinations (offspring):
- Gross pathology and Histopathology were observed
- Statistics:
- No data avaialble
- Reproductive indices:
- Copulation index, fertility index, delivery index, gestation length, implantation index and gestation index were observed
- Offspring viability indices:
- Viability on day 4 were observed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
Body weight: No effect on body weight of treated rats was observed as compared to control.
Reproductive function: estrous cycle: No effects estrous cycle, numbers of corpora lutea or Implantations were observed in treated rats as compared to control.
Reproductive performance: No effects on copulation index, fertility index, delivery index, gestation length, implantation index and gestation index were observed in treated rats as compared to control.
Organ weights : No effect on organ weight of treated rats were in treated rats as compared to control.
Gross pathology: No gross pathological changes were observed in treatd rats as compared to control.
Histopathology: No histopathological changes were observed in treatd rats as compared to control.
other findings No effect on food consumption, hematology, blood chemistry, urinalysis of treated rats were observed as compared to contorl.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on Clinical signs, FOB, Body weight, Food consumption, Urinalysis, Hematology, Blood chemistry, organ weights, reproductive performance and Histopathology
- Remarks on result:
- other: overall no effects on reproductive parameters
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Clinical signs: No clinical signs of toxicity was observed in treated rats
Body weight: No effect on body weight of treated rats was observed in offsprings to treated rats as compared to control.
Gross pathology: No gross pathological changes were observed in offsprings of treated rats as compared to control.
Histopathology: No histopathological changes were observed in offsprings of treated rats as compared to control.
other findings: No effect on number of offspring or live offspring at birth, sex ratio and live birth index of offsprings of treated rats as compared to control.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on number of offspring or live offspring at birth, sex ratio, live birth index, or viability index , gross pathology and Histopathology
- Remarks on result:
- other: overall no effects on developmental parameters
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Fertility and pregnancy data in rats treated orally with test chemical in the combined repeated dose and reproductive/developmental toxicity screening test
|
Administration period |
|||
Dose level (mg/kg) |
0 |
40 |
200 |
1000 |
Number of pairs examined |
12 |
12 |
12 |
12 |
Estrous cycle |
4.08 ± 0.19 |
4.00 ± 0.00 |
4.09 ± 0.30 |
4.04 ± 0.14 |
Irregular estrous cycle |
0/12 |
0/12 |
1/12 |
0/12 |
Number of pairs with successful mating |
12 |
11 |
11 |
12 |
Mating index (%) a) |
100.0 |
91.7 |
91.7 |
100.0 |
Number of pregnant females |
12 |
11 |
11 |
12 |
Fertility index (%) b) |
100.0 |
100.0 |
100.0 |
100.0 |
Pairing days until mating |
2.1 ± 1.1 |
2.7± 1.2 |
3.4 ± 1.2 |
2.6 ± 1.0 |
Number of estrous stages without mating |
0.0 ± 0.0 |
0.3± 0.9 |
0.2 ± 0.4 |
0.0 ± 0.0 |
a) Mating index (%) = (Number of pairs with successful mating/number of pairs examined)×100
b) Fertility index (%) = (Number of pregnant animals/number of pairs with successful mating)×100
Values are expressed as Mean ± S.D.
Delivery and litter data in rats treated orally with test chemical in the combined repeated dose and reproductive/developmental toxicity screening test
|
Administration period |
|||
Dose level(mg/kg) |
0 |
40 |
200 |
1000 |
Number of females examined |
12 |
11 |
11 |
12 |
Number of females with live pups |
12 |
11 |
11 |
12 |
Gestation index (%) a) |
100.00 |
100.00 |
100.00 |
100.00 |
Gestation length (days) |
22.3±0.5 |
22.5 ±0.5 |
22.5±0.5 |
22.4±0.5 |
Number of corpora lutea |
17.8 ±1.5 |
17.2±1.6 |
16.5±1.9 |
17.2±2.9 |
Number of implantation sites |
16.8±1.2 |
16.1±1.4 |
15.5±2.0 |
15.7±3.0 |
Implantation index (%) b) |
95.00 ±4.37 |
93.78 ±4.34 |
94.43 ±4.34 |
90.88 8.66 |
Delivery index (%) c) |
95.23 ± 6.29 |
95.36 ±4.25 |
94.50 ±5.25 |
95.00 4.75 |
Number of pups delivered |
16.0 ±1.1 |
15.4±1.6 |
14.7±2.3 |
14.8 ±2.7 |
Number of live pups on day 0 |
15.8± 1.2 |
15.4 ±1.6 |
14.7±2.3 |
14.8±2.7 |
Number of live pups on day 4 |
15.7 ±1.2 |
15.3 ±1.7 |
14.7 ±2.3 |
14.6 ±2.6 |
Live birth index (%) d) |
98.97±2.41 |
100.00± 0.00 |
100.00±0.00 |
99.51 ±1.70 |
Viability index on day 4 (%) e) |
98.97±2.41 |
99.35 ±2.14 |
100.00±0.00 |
98.92 ±2.54 |
Sex ratio of total number of offspring at birth (M/Total) |
0.50(96/192) |
0.49 (83/169) |
0.55(89/162) |
0.53(94/178) |
Sex ratio of total number of live offspring at birth (M/Total) |
0.51(96/190) |
0.49(83/169) |
0.55(89/162) |
0.53(93/177) |
Sex ratio of total number of live offspring on day 4 (M/Total) |
0.51(96/188) |
0.49(82/168) |
0.55(89/162) |
0.53(93/175) |
Sex ratio of total number of offspring at birth (M/Total, litter) |
0.499± 0.158 |
0.485 ±0.152 |
0.549 ±0.078 |
0.548±0.166 |
Sex ratio of total number of live offspring at birth (M/Total, litter ) |
0.504±0.158 |
0.485±0.152 |
0.549 ±0.078 |
0.546 ±0.167 |
Sex ratio of total number of live offspring on day 4 (M/Total, litter ) |
0.509±0.158 |
0.483 ±0.150 |
0.549 ±0.078 |
0.553 ±0.168 |
Body weight of pups (g) on day 0 male female on day 4 male female |
6.4±0.6 6.1 ±0.6 10.1± 0.9 9.6 ±0.7 |
6.9±0.7 6.5 ±0.8 10.4±1.3 9.9 ±1.5 |
6.9 ±0.7 6.5 ±0.7 10.5 ±1.3 9.8 ±1.2 |
6.8 ±0.8 6.4 ±0.7 10.6±1.8 10.2 ±1.8 |
a) Gestation index (%) = (Number of females with live pups/number of pregnant females)×100
b) Implantation index (%) = (Number of implantation sites/number of corpora lutea)×100
c) Delivery index (%) = (Number of pups delivered/number of implantation sites)×100
d) Live birth index (%) = (Number of live pups on day 0/number of pups delivered)×100
e) Viability index (%) = (Number of live pups on day 4/number of live pups on day 0)×100
Values areexpressed as Mean ±S.D.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw/day for P and F1 generation when Crl:CD (SD) male and female rats were treated with test chemical orally by gavage for 42 days.
- Executive summary:
In combined repeated dose toxicity study with reproduction and developmental screening, Crj:CD(SD)IGS male and female rats were treated with test chemical in the concentration of 0, 40, 200 and 1000 mg/kg bw/day 1 w/v% Tween 80 solution orally by gavage for male 42 days and femalesfrom 14 days before mating to day 4 of lactation (Females (satellite), 42 days).All animals were observed for clinical sign , body weights, food consumption.Males were sacrificed on day 43 of treatment and day 15 of recovery while Females were sacrificed on day 5 of lactation Females (satellite), day 15 of recovery and Offspring on day 4 after birth.
No effect on clinical sign , body weights, food consumption, hematology, clinical chemistry, urinalysis, organ weights, gross pathology and histopathological of treated rats as compared to control. Similarly no effect on estrous cycle, copulation index, fertility index, delivery index, gestation length, numbers of corpora lutea or implantations, implantation index, gestation index, number of offspring or live offspring at birth, sex ratio, live birth index, or viability index on day 4 of offspring were observed as compared to control. In addition, no effect on clinical signs, body weights, gross pathology and histopathology of treated offspings were observed as compared to control. Therfore, NOAEL was considered to be 1000 mg/kg bw/day for P and F1 generation when Crl:CD (SD) male and female rats were treated with test chemical orally by gavage for 42 days.
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