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EC number: 211-089-2 | CAS number: 629-40-3
- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- 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
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- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 13AUG2009 to 17SEP2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance statement. Follows outlined guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Adiponitrile
- EC Number:
- 203-896-3
- EC Name:
- Adiponitrile
- Cas Number:
- 111-69-3
- IUPAC Name:
- adiponitrile
- Details on test material:
- Adiponitrile >99% purity
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Mouse, CBA/J strain, inbred, SPF-Quality. 20 females (nulliparous and non-pregnant), five females per group. Young adult animals (approx. 11 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean. A health inspection was performed prior to treatment, to ensure that the animals are in a good state of health. Special attention was paid to the ears, which were intact and free from any abnormality. The results of a reliability test with Hexylcinnamaldehyde, performed not more than 6 months previously, are summarized in the appendix. Similar procedures were used in the reliability test and in this study.
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 21.6 - 23.5ºC), a relative humidity of 40-70% (actual range: 42 - 74%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation
Individual housing in labeled Macrolon cages (MI type; height 12.5 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) was supplied as cage-enrichment.
Acclimatization period
The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. Accommodation was as described above except that the animals were group housed in Macrolon cages (MIII type; height 18 cm).
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- induction (test substance; % w/w)
0 (Dimethyl formamide)
25
50
100 - No. of animals per dose:
- 5
- Details on study design:
- Skin reactions / Irritation
No irritation or oedema of the ears was observed in any of the animals examined.
Macroscopy of the auricular lymph nodes and surrounding area (Table 2)
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size, except for one node of one control animal which was considered small in size.
Body weights
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
Radioactivity measurements
Mean DPM/animal values for the experimental groups treated with test substance concentrations 25, 50 and 100% were 314, 448 and 610 respectively.
The mean DPM/animal value for the vehicle control group was 443.
Toxicity and mortality
One animal (at 100%) was found dead and one moribund animal (at 50%) was sacrificed for ethical reasons on Day 2 prior to dosing. The moribund animal showed hunched and flat posture, piloerection, laboured breathing, ptosis and hypothermia on Day 2.
Since no further mortality occurred and no symptoms of systemic toxicity were observed in the surviving animals of the main study, these deaths were considered to be of incidental nature and not test substance related. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A reliability check is carried out at regular intervals to check the sensitivity of the test system and the reliability of the experimental techniques as used by NOTOX. In this study, performed in February 2009, females of the CBA/J mouse strain (from Charles River France, L¿Arbresle Cedex, France) were checked for the sensitivity to Alpha- Hexylcinnamaldehyde, technical grade. The females were approx. 10 weeks old at commencement of the study. The study was based on the OECD Guideline No. 429, EC No 440/2008, Part B.42 and EPA, OPPTS 870.2600 ¿Skin Sensitization¿. Alpha-hexylcinnamicaldehyde, tech. 85% (CAS no. 101-86-0) was fabricated under lot no. 13102MO (Sigma- Aldrich, Steinheim, Germany). Concentrations used for this study were 5, 10 and 25% in Acetone/Olive oil (4:1 (v/v)).
Results and discussion
- Positive control results:
- The SI values calculated for the substance concentrations 5, 10 and 25% were 2.0, 2.2 and 4.2 respectively. An EC3 value of 16.0 % was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6 monthly HCA reliability checks of the recent years were 13.1, 15.6, 14.1, 13.8 and 13.9%.
Based on the results, it was concluded that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
The raw data, protocol and report from this study are kept in the NOTOX archives. The test described above was performed in accordance with NOTOX Standard Operating Procedures and the report was audited by the QA-unit.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: group 2 0.7 +/- 0.2 group 3 1.0 +/- 0.2 group 4 1.4 +/- 0.4 group 1 1. +/- 0.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- 1-399 2-342 3-448 4-779 5-247 6-243 7-244 8-211 9-415 10-457 11-544 12-423 13-454 14-371 15-Animals were found dead or sacrificed for ethical reasons on Day 2 16-Animals were found dead or sacrificed for ethical reasons on Day 2 17-825 18-707 19-394 20-513 group 2 mean 314 +/- 51 group 3 mean 448 +/- 36 group 4 mean 610 +/- 96 group 1 mean 443 +/- 90
Any other information on results incl. tables
group | test substance (%w/w) | mean DPM +/- SEM | SI +/- SEM |
2 | 25 | 314 ± 51 | 0.7 ± 0.2 |
3 | 50 | 448 ± 36 | 1.0 ± 0.2 |
4 | 100 | 610 ± 96 | 1.4 ± 0.4 |
1 | 0 (vehicle) | 443 ± 90 | 1.0 ± 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- ADIPONITRILE (ADN) would not be regarded as skin sensitizer and has no obligatory labeling requirement for sensitization by skin contact according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.
- Executive summary:
According to an OECD 429 study, the test substance did not ellicit an SI value of >=3 on 100% adiponitrile and therefore ADN would be considered a non-sensitizer.
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