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EC number: 500-007-3 | CAS number: 9003-50-3
- 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
- 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:
- 18 April 2016 to 10 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study was conducted according to OECD, EU, US EPA and JMAFF test guidelines in an accredited GLP laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- yes
- Remarks:
- Deviations from the minimum level of daily mean relative humidity occurred. Day 10 Group 2, no observations for clinical signs performed
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008, including themost recent amendments.
- Deviations:
- yes
- Remarks:
- Deviations from the minimum level of daily mean relative humidity occurred. Day 10 Group 2, no observations for clinical signs performed.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- EPA 712-C-02-190, 2002.
- Deviations:
- yes
- Remarks:
- Deviations from the minimum level of daily mean relative humidity occurred. Day 10 Group 2, no observations for clinical signs performed.
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan,Notification No 8147, November 2000; including the most recent partial revisions.
- Deviations:
- yes
- Remarks:
- Deviations from the minimum level of daily mean relative humidity occurred. Day 10 Group 2, no observations for clinical signs performed.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Heptanal, oligomeric reaction products with aniline
- EC Number:
- 500-007-3
- EC Name:
- Heptanal, oligomeric reaction products with aniline
- Cas Number:
- 9003-50-3
- Molecular formula:
- (C7H14O)n.(C6H7N)n
- IUPAC Name:
- Heptanal, oligomeric reaction products with aniline
- Test material form:
- liquid
- Details on test material:
- Test item: 207368/A
Identification: Hepteen Base®
Appearance: Clear amber liquid (determined by Charles River Den Bosch)
Batch: LT5C30Y170
Purity/Composition: 99.7%
Test item storage: At room temperature
Stable under storage conditions until: 30 November 2016 (retest date)
1
- Specific details on test material used for the study:
- pH (1% in water, indicative range) 8.0 – 7.8 (determined by Charles River Den Bosch)
Specific gravity/density 0.9130
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Age and body weight: Young adult animals (approx. 8-9 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
Identification: Earmark and tail mark
Health inspection At least prior to dosing. It was ensured that the animals were healthy and without any abnormality that might have affected the study integrity.
Animal Husbandry
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle: the photoperiod was between 07:00 and 19:00 hrs daily. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study.
Accommodation
Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Method: Oral gavage, using plastic feeding tubes. The test item was stirred on a magnetic stirrer during dosing.
Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test item. Water was available ad libitum. - Doses:
- Single dose of 2000 mg/kg (2.19 mL/kg) body weight on Day 1.
- No. of animals per sex per dose:
- 2 consecutive groups of 3 female rats at 2000 mg/kg body weight
- Control animals:
- no
- Details on study design:
- The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
The second group of animals at 2000 mg/kg was dosed one week after the first group. - Statistics:
- The LD50 cut-off value was established based on OECD guideline 423. No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
- Preliminary study:
- No preliminary study conducted
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal was found dead on Day 9. No further mortality occurred.
- Clinical signs:
- Hunched posture, piloerection and/or ptosis were noted for the animals between Days 1 and 5.
- Body weight:
- Body weight loss or reduced body weight gain was noted for all animals during the first week of the study. The surviving animals gained weight between Days 1 and 15.
- Gross pathology:
- Abnormalities of the stomach (forestomach: irregular surface) and small intestines (wall: dark red discouloration) were noted for the animal that was found dead during the study, at macroscopic post mortem examination. Macroscopic examination of the other animals did not reveal any abnormalities.
- Other findings:
- None
Any other information on results incl. tables
Mortality Data
Test day |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Hours after treatment |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Females 2000 mg/kg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Females 2000 mg/kg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- = no mortality
Clinical signs
Test day |
Max grade |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Hours after treatment |
|
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Females 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
(1) |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur Piloerection |
(1) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various Ptosis |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
(1) |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various Ptosis |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
(1) |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur Piloerection |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various Ptosis |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
Skin/fur Piloerection |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
Various Ptosis |
(3) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
|
|
|
|
|
|
Animal 5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur Piloerection |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various Ptosis |
(3) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Animal 6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posture |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur Piloerection |
(1) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Various Ptosis |
(3) |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- = sign not observed
Body weight (grams)
Sex/dose level |
Animal |
Day 1 |
Day 8 |
Day 15 |
FEMALES 2000 MG/KG |
1 |
159 |
58 |
194 |
|
2 |
138 |
132 |
157 |
|
3 |
158 |
132 |
172 |
|
Mean |
152 |
141 |
174 |
|
ST. Dev. |
12 |
15 |
19 |
|
N |
3 |
3 |
3 |
FEMALES 2000 MG/KG |
|
|
|
|
|
4 |
152 |
125* |
--- |
|
5 |
172 |
168 |
186 |
|
6 |
161 |
161 |
194 |
|
Mean |
162 |
151 |
190 |
|
ST. Dev. |
10 |
23 |
6 |
|
N |
3 |
3 |
2 |
* Animal was found dead on Day 9. Body weight at death: 115 gram
Macroscopic findings
Animal |
Organ |
Finding |
Day of death |
FEMALES 2000 MG/KG |
|
|
|
1 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
2 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
3 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
FEMALES 2000 MG/KG |
|
|
|
4 |
Stomach Small intestines |
Forestomach: irregular surface, Wall: discolouration, dark red. |
Spontaneous death Day 9 after treatment |
5 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
6 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Hepteen Base® in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight. Based on these results:
-according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Hepteen Base® does not have to be classified and has no obligatory labelling requirement for oral toxicity. - Executive summary:
Assessment of acute oral toxicity with Hepteen Base® in the rat (Acute Toxic Class Method).
The study was carried out based on the guidelines described in:
OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"
Commission Regulation (EC) No 440/2008, B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method" EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"
JMAFF Guidelines (2000), including the most recent revisions.
Hepteen Base® was administered by oral gavage to two consecutive groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15).
One animal was found dead on Day 9. No further mortality occurred.
Hunched posture, piloerection and/or ptosis were noted for the animals between Days 1 and 5.
Body weight loss or reduced body weight gain was noted for all animals during the first week of the study. The surviving animals gained weight between Days 1 and 15.
Abnormalities of the stomach (forestomach: irregular surface) and small intestines (wall: dark red discouloration) were noted for the animal that was found dead during the study, at macroscopic post mortem examination.
Macroscopic examination of the other animals did not reveal any abnormalities.
The oral LD50 value of Hepteen Base® in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 2500 mg/kg body weight. Based on these results:
-according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), Hepteen Base® does not have to be classified and has no obligatory labelling requirement for oral toxicity.
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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