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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-028-8 | CAS number: 67990-05-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 8 MAR 2012 to 17 MAY 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 423), GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(5-chloro-2-methoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide
- EC Number:
- 268-028-8
- EC Name:
- N-(5-chloro-2-methoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide
- Cas Number:
- 67990-05-0
- Molecular formula:
- C32H25ClN4O5
- IUPAC Name:
- N-(5-chloro-2-methoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl]-2-naphthamide
Constituent 1
- Specific details on test material used for the study:
- In October 2011 the EU commission published a recommendation (2011/696/EU) on the definition of nanomaterials. From the results of analyses it is concluded that the registered substance C.I.Pigment Red 269 falls within the boundaries of the nanomaterial definition. Hence, studies were performed using the nanomaterial.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0815 for steps 1 and 2, 0715 for step 3)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control,
microbiological controls at regular intervals)
- The animals were kept in groups / individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
(lot no. 110811 for steps 1 and 2, 261111 for step 3)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all animals.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
Following the period of fasting the animals were weighed and the test item was administered. Food was provided again
approximately 4 hours post dosing.
The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mL/kg body weight. - Doses:
- Since no or only a very low acute toxicity was expected the starting dose was selected to be 2000 mg/kg body weight.
No compound-related mortality was recorded for any animal of step 1 or 2. However, no correction to the active ingredient
content (i.e. content C.I.) was made in these two steps. In order to assess the toxicity of the active ingredient at a dose of 2000 mg/kg
as initially planned, three additional animals were treated at 2000 mg/kg with correction to the active ingredient content (i.e. content C.I.).
No compound-related mortality and no adverse clinical signs were recorded for any animal of step 3. Based on these results and for
animal welfare reason the second confirming step at 2000 mg/kg body weight with correction to the active ingredient content (i.e. content C.I.)
of the test item was not performed. The data collected were sufficient to assess the potential toxicity of the test item. - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Observation Period
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
Weight Assessment
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and
with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded.
Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities
were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory,
circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined.
Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology
At the end of the observation period the surviving animals were sacrificed with an overdosage of pentobarbital injected
intraperitoneally (Narcoren®, Merial; lot no.: 218121; expiry date: 12/2014) at a dosage of approximately 8 mL/kg bw.
All animals were subjected to gross necropsy. All gross pathological changes were recorded and in case of findings the
tissues were preserved for a possible histopathological evaluation. The preserved tissues of which no histopathological
evaluation was made will be discarded 3 months after the release of the final report unless otherwise agreed upon with the sponsor. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results,
a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: content C.I.
- Remarks on result:
- other: no animal died within the 14 day observation period
- Mortality:
- All animals survived until the end of the study.
- Clinical signs:
- other: No signs of toxicity were observed in any animal.
- Gross pathology:
- At necropsy, no macroscopic findings were observed in any animal of any step.
Any other information on results incl. tables
Table: Body Weight Development - Absolute Body Weights in g and Body Weight Gain in %
Animal No. / |
g |
g |
g |
% |
Step 1 (1860 mg/kg Body Weight) |
||||
1 / female |
154 |
182 |
199 |
29 |
2 / female |
161 |
187 |
197 |
22 |
3 / female |
145 |
172 |
188 |
30 |
Step 2 (1860 mg/kg Body Weight) |
||||
4 / female |
156 |
180 |
190 |
22 |
5 / female |
163 |
195 |
201 |
23 |
6 / female |
161 |
190 |
196 |
22 |
Step 3 (2000 mg/kg Body Weight) |
||||
7 / female |
184 |
207 |
212 |
15 |
8 / female |
188 |
205 |
228 |
21 |
9 / female |
176 |
189 |
205 |
16 |
Table: LD50 Cut-Off
Dose |
Number of |
Number of Intercurrent Deaths |
LD50 Cut-Off |
1860 mg/kg bw |
6 |
0 |
unclassified |
2000 mg/kg bw |
3 |
0 |
unclassified |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of the active ingredient after a single oral administration to female rats, observed over a period of 14 days is greater than 2000 mg/kg body weight.
- Executive summary:
Acute oral toxicity was investigated according to OECD guideline 423. Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 1860 mg/kg body weight (no correction to the active ingredient content (i.e. content C.I.) was made). The test item was suspended in the vehicle cottonseed oil at a concentration of 0.186 g/mL and administered at a dose volume of 10 mL/kg.
One group of three female WISTAR Crl: WI(Han) rats, was treated with the test item by oral gavage administration at a dosage
of 2000 mg/kg body weight considering the active ingredient content (i.e. content C.I.) of the test item. The test item was suspended in the vehicle cottonseed oil
at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days.
The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs.
All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period.
Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
Results per Step
Step
Sex/No.
Dose (mg/kg)
Number of Animals
Number of Intercurrent Deaths
1
female/1-3
1860
3
0
2
female/4-6
1860
3
0
3
female/7-9
2000
3
0
All animals survived until the end of the study without showing any signs of toxicity.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step. The oral LD50 in rats is > 2000 mg/kg bw.
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.