Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 437-450-6 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 May 1999 and 1 June 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 July 1992)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- Method B1 bis in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 437-450-6
- EC Name:
- -
- Cas Number:
- 64654-05-3
- Molecular formula:
- Hill formula: C28 H37 N
- IUPAC Name:
- N-(dodecylphenyl)naphthalen-1-amine
- Test material form:
- liquid: viscous
- Details on test material:
- Sponsor's identification: APAN
Description: redbrown viscous liquid
Lot number: EL01010B01/KZ8911.5
Storage conditions: room temperature in the dark
1
- Specific details on test material used for the study:
- No further details specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley CD (Crl : CD (SD) IGS BR) strain rats supplied by Charles River (UK) Ltd, Margate, Kent, UK were used. At the start of the study the males weighed 219 to 232g, and the females 201 to 232g, and were eight to twelve weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with wood flakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- For the purpose of the study the test material was freshly prepared, as required, as a solution in arachis oil BP. The preparations were mixed thoroughly using a vortex mixer.
- Doses:
- Preliminary Study: 500 & 2000 mg/kg
Main Study (Limit Study): 2000 mg/kg - No. of animals per sex per dose:
- Preliminary Study: 1 animal/sex/dose
Main Study: 5 animals/sex - Control animals:
- no
- Details on study design:
- Preliminary Study
Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and then daily for seven days. Morbidity and mortality checks were made twice daily.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
Main Study (Limit Study)
Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 1, 2, 3, 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. The 'discriminatory dose' was also identified. This is the highest of the four fixed dose levels which can be administered without causing compound-related mortality (including humane kills). If possible the signs of evident toxicity were also identified. Evident toxicity is defined as the toxic effects which are of a severity such that administration at the next highest level could result in mortality.
Results and discussion
- Preliminary study:
- There were no deaths at dose levels of 500 and 2000 mg/kg bodyweight.
Clinical signs of toxicity noted in animals treated with 2000 mg/kg were piloerection and/or hunched posture.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- Hunched posture was noted in three female animals during the day of dosing and/or one day after dosing. No other clinical signs of toxicity were noted during the study.
- Body weight:
- All animals showed expected gains in bodyweight over the 14-day study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No further findings noted in the study report.
Any other information on results incl. tables
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE PRELIMINARY STUDY
DOSE LEVEL mg/kg |
Animal Number and Sex |
Hours Post Dosing (Day 0) |
Day Number |
|||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
500 |
1-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2000 |
3-0 Male |
0 |
0 |
0 |
HP |
H |
0 |
0 |
0 |
0 |
0 |
0 |
4-0 Female |
0 |
0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 = no signs of systemic toxicity
H = hunched posture
P = pilo-erection
INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE LIMIT STUDY
DOSE LEVEL mg/kg |
Animal Number and Sex |
Hours Post Dosing (Day 0) |
Day Number |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
5-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5-1 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-2 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-3 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5-4 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6-2 Female |
0 |
0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6-3 Female |
0 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6-4 Female |
0 |
0 |
0 |
0 |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = no signs of systemic toxicity
H = hunched posture
INDIVIDUAL BODYWEIGHTS AND BODYWEIGHT CHANGES IN THE LIMIT STUDY
DOSE LEVEL mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Increment (g) During Days |
|||||||||
0 |
1 |
2 |
3 |
7 |
14 |
0-1 |
1-2 |
2-3 |
3-7 |
7-14 |
||
2000 |
5-0 Male 5-1 Male 5-2 Male 5-3 Male 5-4 Male 6-0 Female 6-1 Female 6-2 Female 6-3 Female 6-4 Female |
219 223 232 222 224 209 232 201 229 224 |
224 230 242 226 228 212 239 203 235 229 |
232 243 258 234 240 220 251 208 248 238 |
235 248 262 238 244 221 245 208 249 236 |
252 280 300 270 275 233 268 216 267 249 |
293 323 354 308 311 245 292 218 303 272 |
5 7 10 4 4 3 7 2 6 5 |
8 13 16 8 12 8 12 5 12 9 |
3 5 4 4 4 1 6 0 1 -2 |
17 32 38 32 31 12 23 8 18 13 |
41 43 54 38 36 12 24 2 36 23 |
INDIVIDUAL NECROPSY FINDINGS IN THE LIMIT STUDY
DOSE LEVEL mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
2000 |
5-0 Male 5-1 Male 5-2 Male 5-3 Male 5-4 Male 6-0 Female 6-1 Female 6-2 Female 6-3 Female 6-4 Female |
Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 |
No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The discriminatory dose was identified as 2000 mg/kg bodyweight.
The acute oral median lethal dose (LD50) of the test material, APAN, in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification under EC labelling regulations. No symbol or risk phrase are required. - Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method complied with that described in the OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity – Fixed Dose Method" (adopted 1 7 July 1 992) and Method B 1 bis in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
Following a preliminary study in which there were no deaths at dose levels of 500 and 2000 mg/kg, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a solution in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross necropsy.
There were no deaths. Hunched posture was noted in three female animals. No other clinical signs of toxicity were noted during the study.
All animals showed expected gains in bodyweight during the 14-day study period.
No abnormalities were noted at necropsy.
The discriminatory dose was identified as 2000 mg/kg bodyweight.
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification under EC labelling regulations. No symbol or risk phrase are required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.