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EC number: 223-517-5 | CAS number: 3937-56-2
- 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
Endpoint summary
Administrative data
Description of key information
Short summary and overall relevance of the provided information on acute oral toxicity
A rat acute oral toxicity study has been conducted on 1,9 -Nonanediol under OECD 401.
In a rat acute oral toxicity study 5 male and 5 female Sprague-Dawley rats received as single oral dose (via gavage) of 1,9-Nonanediol suspended in 0.5% w/v methylcellulose at 1260, 2000, 3200, 4000 or 5200 mg/kg bw. Rats were observed for 14 days. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period.
Treatment related clinical signs included hunched post mortem abnormal gait, ataxia and lethargy in the majority of animals dose at all levels. Group mean body weight gains were not affected. Mortality was observed in males dosed at 2000 mg/kg bw and above an in females dosed at 3200 mg/kg bw and above. No abnormalities were recorded at necropsy.
Short summary and overall relevance of the provided information on acute inhalation toxicity
In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as exposure of humans via inhalation is not likely taking account the vapour pressure of the test article, 1,9 Nonanediol.
Short summary and overall relevance of the provided information on acute dermal toxicity
In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh is scientifically robust.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-10-11 to 1988-11-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Chemical name: 1,9-Nonanediol
- CAS no.: 3937-56-2
- Purity: 99.9% - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight at dosing: m: 107-154g; f: 108-137g
Source: Charles River Portage, USA
Acclimation period: 12 days
Diet: Labsure LAD 1, ad libitum. animals fasted overnight prior to dosing and ~4 h post dosing
Water: Municipal water, ad libitum
Housing: Housed 5 animals of the same sex/cage
Temperature: 22-24°C
Humidity: 56%
Air changes: 15 changes/h
Photoperiod: 12 hours light/dark - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1% methyl cellulose
- Details on oral exposure:
- Refer to Details on study design
- Doses:
- Preliminary study: 2500 mg/kg bw (2 animals/sex)
Main study: 1260, 2000, 3200, 4000, 5000 mg/kg bw (5 animals/sex) - No. of animals per sex per dose:
- Refer to Doses
- Control animals:
- no
- Details on study design:
- Animals (5/sex) were fasted overnight prior to compound administration. Animals recieved 1,9-Nonanediol as a single dose administered by oral gavage in 1% MC (dose volume 20 mL/kg bw) at 1260, 2000, 3200, 4000 or 5000 mg/kg bw. Clinical signs and body weight were monitored for 14 days following dosing. Animals were then necropsied and examined macroscopically.
- Statistics:
- Probit analysis
- Preliminary study:
- The acute median lethal oral dose to male and female rats was >2500 mg/kg bw.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 200 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 2 200 - ca. 4 800
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 2 500 - ca. 6 000
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- ca. 2 600 - ca. 4 800
- Mortality:
- Preliminary toxicity test:
1 male and 1 female died within 2 h of dosing
Main study:
Mortality was observed in males at 2000, 3200 and 5000 mg/kg bw and females at 3200, 4000 and 5000 mg/kg bw (refer to table below) - Clinical signs:
- other: Piloerection was observed in all rats within 5 minutes of dosing. This was accompanied by: - hunched posture, abnormal gait and lethargy in the majority of rats dosed at 1260, 2000, 3200 and 4000 mg/kg bw - decreased respiration and pallor of the extremit
- Gross pathology:
- No treatment related effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw in males and females. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9-Nonanediol has no obligatory labelling requirement for acute oral toxicity and is unclassified
- Executive summary:
In a rat acute oral toxicity study 5 male and 5 female Sprague-Dawley rats received as single oral dose (via gavage) of 1,9-Nonanediol suspended in 0.5% w/v methylcellulose at 1260, 2000, 3200, 4000 or 5200 mg/kg bw. Rats were observed for 14 days. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period.
Treatment related clinical signs included hunched post mortem abnormal gait, ataxia and lethargy in the majority of animals dose at all levels. Group mean body weight gains were not affected. Mortality was observed in males dosed at 2000 mg/kg bw and above an in females dosed at 3200 mg/kg bw and above. No abnormalities were recorded at necropsy.
The EU endpoint conclusion was that the rat acute oral LD50 was >2000 mg/kg bw in males and females. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9-Nonanediol has no obligatory labelling requirement for acute oral toxicity and is unclassified.
Reference
Table 7.2/01-1
Doses, mortality/ animals treated
Dose (mg/kg bw) |
Mortality ratio males |
Mortality ratio females |
Mortality ratio Gender combined |
Preliminary study |
|||
2500 |
1/2 |
1/2 |
2/4 |
Main study |
|||
1260 |
0/5 |
0/5 |
0/10 |
2000 |
4/5 |
0/5 |
5/10 |
3200 |
2/5 |
2/5 |
4/10 |
4000 |
0/5 |
2/4* |
2/9* |
5000 |
5/5 |
5/5 |
10/10 |
* single animal died due to intubation error, excluded from mortality assessment
Table 7.2/01-2
Main study group body weights
Parameter |
Body weights (mg/kg bw) |
Body weights (mg/kg bw) |
||||||||
1260 |
2000 |
3200 |
4000 |
5000 |
1260 |
2000 |
3200 |
4000 |
5000 |
|
Day 1 |
118 |
144 |
142 |
128 |
116 |
119 |
124 |
121 |
124 |
120 |
Day 8 |
187 |
239 |
226 |
206 |
- |
163 |
174 |
162 |
169 |
- |
Day 15 |
237 |
299 |
278 |
261 |
- |
187 |
193 |
183 |
194 |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 200 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions) guideline study without detailed documentation
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Study period:
- n/a
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Qualifier:
- no guideline required
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, it is scientifically rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh.
- Executive summary:
In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, it is scientifically rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Comparison with the CLP criteria
Oral and dermal
The acute oral LD50 in the rat of 3200/3600 mg/kg bw for males/females exceeds the values for which classification for acute oral toxicity is required (i.e. > 2000 mg/kg bw). Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, 1,9 -Nonanediol has no obligatory labelling requirement for acute oral toxicity and is unclassified.
The test article, 1,9- Nonanediol does not met the criteria for classification for acute toxicity or STOT SE by the oral route and no systemic toxicity was observed in in vivo studies with dermal exposure (skin irritation and skin sensitisation]).
In accordance with the ECHA Chapter R.7a guidance and the EC CARACAL meeting, a waiver is requested as 1,9-Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for the acute dermal toxicity endpoint is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh is scientifically robust.
Inhalation
In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as exposure of humans via inhalation is not likely taking account the vapour pressure of the test article, 1,9 Nonanediol.
Overall conclusion
In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity and acute inhalation toxicity endpoint (based on exposure) is scientifically robust endpoint as stated in the R.7a guidance for REACh and these endpoints are not classified.
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