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EC number: 938-925-5 | CAS number: -
- 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 December 14, 2011 to January 3, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of n-octanol and acrylic acid, first distillation pitch
- EC Number:
- 938-925-5
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Reaction products of n-octanol and acrylic acid, first distillation pitch
- Details on test material:
- - Physical state: Light yellow viscous liquid
- Analytical purity: UVCB
- Expiration date of the lot/batch: May 11, 2013
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 10-11 weeks old.
- Weight at study initiation: Given in the table
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo S.P.P.S., Argenteuil, France) and paper as cageenrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0ºC (actual range: 19.9 - 21.7ºC)
- Humidity (%): 40-70% (actual range: 42 - 62%)
- Air changes (per hr): 15 approx.
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours darkness per day.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.081 mL/kg body weight
- Doses:
- 2000 mg/kg (2.081 mL/kg) body weight
- No. of animals per sex per dose:
- 6 females separated in two groups of three
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations once daily and weighing on days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded: Maximum grade 4: grading slight to very severe. Maximum grade 3: grading slight to severe. Maximum grade 1: presence is scored.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Hunched posture and/or uncoordinated movements were noted in all animals on Day 1. One animal showed hunched posture on Day 2 also.
- Other findings:
- - Other observations:
Macroscopic findings: Two animals showed reddish discoloration of the thymus. No other abnormalities were found at macroscopic post mortem examination of the animals
Any other information on results incl. tables
Table 1. 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Males 2000 mg/kg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Females 2000 mg/kg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Table 2. Clinical signs
TEST DAY |
|
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
HOURS AFTER TREATMENT |
Max Grade |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MALES 2000 mg/kg |
|
|||||||||||||||||
ANIMAL 1 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Gait / motility Uncoordinated movements |
(3) |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 2 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Gait / motility Uncoordinated movements |
(3) |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 3 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Gait / motility Uncoordinated movements |
(3) |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
||||||||||||||||||
FEMALES 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANIMAL 4 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 5 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/fur Piloerection |
(1) |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 6 |
|
|||||||||||||||||
Posture Hunched posture |
(1) |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- = SIGN NOT OBSERVED / . = OBSERVATION NOT PERFORMED / + = ANIMAL DEAD
Table 3. Body weights (gram)
SEX/DOSE LEVEL |
ANIMAL |
DAY 1 |
DAY 8 |
DAY 15 |
MALES 2000 mg/kg |
1 |
189 |
209 |
210 |
|
2 |
174 |
197 |
210 |
|
3 |
180 |
199 |
217 |
|
||||
|
||||
|
MEAN |
181 |
199 |
212 |
|
ST. DEV. |
8 |
3 |
4 |
|
N |
3 |
3 |
3 |
|
||||
FEMALES 2000 mg/kg |
4 |
197 |
226 |
229 |
|
5 |
170 |
192 |
189 |
|
6 |
197 |
244 |
241 |
|
||||
|
||||
|
MEAN |
188 |
221 |
220 |
|
ST.DEV. |
16 |
26 |
27 |
|
N |
3 |
3 |
3 |
Table 4. Macroscopic findings.
ANIMAL |
ORGAN |
FINDING |
DAY OF DEATH |
MALES 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 |
Thymus |
Discolouration, reddish |
Scheduled necropsy Day 15 after treatment |
5 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
6 |
Thymus |
Discolouration, reddish |
Scheduled necropsy Day 15 after treatment |
|
|
||
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Reaction products of n-octanol and acrylic acid, first distillation pitch in Wistar rats was determinated to be greater than 2000 mg/kg b.w.
- Executive summary:
The acute oral toxicity of the substance was determinated according to the OECD 423 test guideline with GLP. The oral LD50 value of Reaction products of n-octanol and acrylic acid, first distillation pitch in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the: Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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