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Diss Factsheets
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EC number: 201-855-4 | CAS number: 88-74-4
- 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
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study conducted in compliance with GLP regulations. Original report not available. Data, reliability and rationale adopted according to OECD SIDS (2003) (publicly available peer reviewed source). Study according to OECD 422; long male treatment to have 9 weeks exposure, like females. Organs were examined as in 422 but no biochemistry or hematology was measured.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report for SIAM 13 (o-nitroaniline) November 6-9, 2001 Bern, Final July 2003.
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- UNEP Publications
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:
- As the reprotoxicity part of the OECD 422 guideline, 12 nulliparus females and 12 males were used up to the gestation period. 10 animals per sex were used to continue the reprotoxicity part of the study and the examinations.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-nitroaniline
- EC Number:
- 201-855-4
- EC Name:
- 2-nitroaniline
- Cas Number:
- 88-74-4
- Molecular formula:
- C6H6N2O2
- IUPAC Name:
- 2-nitroaniline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males: from 4 weeks prior to mating, during mating, gestation of the females: i.e: 9 weeks.
Females: from 4 weeks prior to mating, during mating, gestation and lactation periods until post-partum day 3. Approximately 9 weeks. - Frequency of treatment:
- Daily (7 days a week)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150, 450 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
The only signs related to treatment were piloerection, salivation and matted fur observed at post-dose observations. Matted fur was also observed as clinical signs performed at weekly intervals in males and females of the high-dose group.
No indication of cyanosis was noted as a parameter for hematotoxicity (MetHemoglobin formation).
BODY WEIGHT (PARENTAL ANIMALS)
Statistically significant reduction in body weight were observed at several weighing times in high- and mid-dose groups (males and females: 5 to 6%) during the treatment. A significant reduction in terminal bodyweight or bodyweight gain was observed in high-dose males (6%) compared to controls, and more important in dams on gestation day 20 (bwg: -15%) and on day +4 post-partum (weight loss in 5 females) in high-dose females.
This had a direct effect on pups (post-partum deaths were seen in dams with lower bwg at day 20 or loss at day +4): an increased incidence in the number of pups found dead was observed between days 0 and 2 post partum in the high dose, with a significant increase of male pup deaths.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
Reproductive parameters : The copulatory and fertility index, as well as the pre-coital intervals, were not affected by treatment. Implantation and pre-birth loss were unaffected by treatment.
ORGAN WEIGHTS (PARENTAL ANIMALS)
Parental terminal organ weights: No differences were observed in absolute and relative organ weights of male parents.
GROSS PATHOLOGY/HISTOPATHOLOGY (PARENTAL ANIMALS)
Macroscopic and microscopic observations of parental generation: macroscopic and microscopic examinations of all organs, including spermatogenic cycle, did not reveal any treatment-related effects. Control and treted females showed persistent corpora lutea which was considered to be a physiological condition during lactation.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: general toxicity
- Remarks on result:
- other: Generation: F0 and F1 (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reproductive parameters
Results: F1 generation
Details on results (F1)
F1 results: litter viability and growth and sex-ratios: Litter size and litter weight were statistically significantly reduced on day 4 post-partum in the high-dose group when compared to controls, while a statistically significant increase in cumulative loss was also observed in the same group.
In addition, a statistically significant increase in male pup death was observed in the high-dose group compared to controls.
GROSS PATHOLOGY (OFFSPRING)
F1 results: Necropsy findings in decedent pups: the findings observed at necropsy in decedent pups were similar in the control and the treated groups. Necropsy findings in F1 pups at day 4 post-partum: in general there were no particular differences between control and treated groups, with the exception of 2 pups each in the mid- and highdose groups that showed abnormal size of the median lobe of the liver in association with an abnormal area and abnormal color.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
It was concluded that all reproductive parameters were unaffected by treatment at 450 mg/kg bw and the general toxicity NOAEL is = 50 mg/kg bw / day for F0 and F1 generations.
Applicant's summary and conclusion
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.
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