Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 12, 2012 to January 26, 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- 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:
- male/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 weeks old.
- Weight at study initiation: Given in the table
- 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. During the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18 cm).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3.0ºC (actual range: 19.8 - 22.1ºC)
- Humidity (%): 40-70% (actual range: 39 - 66%)
- Air changes (per hr): 15 approx.
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours darkness per day.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 25 cm² for males and 18 cm² for females.
- % coverage: 10% of the total body surface.
- Type of wrap if used: dressing consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned of residual test substance using tap water.
- Time after start of exposure: 24 h.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (2.081 mL/kg) bw.
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg (2.081 mL/kg) bw.
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Observation once daily; weighing days 1 (pre-administration), 8 and 15.
- Other examinations performed:
clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured.
- Clinical signs:
- other: Chromodacryorrhea and/or piloerection were noted among the animals on Days 1 and/or 2.
- Other findings:
- One male showed dark red discolouration of the lungs at macroscopic post mortem examination. No further 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 |
(1) |
|
||||||||||||||||
ANIMAL 1 Skin/fur piloerection |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
ANIMAL 2 No clinical signs noted |
|
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 3 Skin/fur Scales (treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 4 Secretion/excretion Chromodacryorrhoea (Snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 5 Secretion/excretion Chromodacryorrhoea (Snout) |
(3) |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
||||||||||||||||||
FEMALES 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANIMAL 6 No clinical signs noted |
|
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 7 Skin/fur Scales (treated skin) |
(3) |
- |
- |
- |
- |
- |
- |
1 |
1 |
1 |
- |
1 |
1 |
- |
- |
- |
- |
- |
ANIMAL 8 Skin/fur Piloerection |
(1) |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion/excretion Chromodacryorrhoea (Snout) |
(3) |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 9 Skin/fur Piloerection |
(1) |
- |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Secretion/excretion Chromodacryorrhoea (Snout) |
(3) |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 10 Skin/fur Piloerection |
(1) (3) |
- - |
- - |
1 - |
1 - |
- - |
- 1 |
- 1 |
- 1 |
- 1 |
- - |
- - |
- - |
- - |
- - |
- - |
- - |
- - |
Secretion/excretion Chromodacryorrhoea (Snout) |
(3) |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Table 3. Body weigh (grams)
SEX/DOSE LEVEL |
ANIMAL |
DAY 1 |
DAY 8 |
DAY 15 |
MALES 2000 mg/kg |
1 |
288 |
290 |
325 |
|
2 |
270 |
273 |
300 |
|
3 |
282 |
290 |
314 |
|
4 |
283 |
292 |
324 |
|
5 |
271 |
282 |
305 |
|
MEAN |
279 |
285 |
314 |
|
ST. DEV. |
8 |
8 |
11 |
|
N |
5 |
5 |
5 |
|
||||
FEMALES 2000 mg/kg |
6 |
196 |
194 |
210 |
|
7 |
211 |
209 |
221 |
|
8 |
194 |
188 |
204 |
|
9 |
188 |
185 |
201 |
|
10 |
198 |
196 |
214 |
|
MEAN |
197 |
194 |
210 |
|
ST.DEV. |
8 |
9 |
8 |
|
N |
5 |
5 |
5 |
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 |
4 |
Lungs |
Discolouration, dark red |
Scheduled necropsy Day 15 after treatment |
5 |
|
|
Scheduled necropsy Day 15 after treatment |
FEMALES 2000 mg/kg |
|||
6 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
7 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
8 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
9 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
10 |
|
No findings noted |
Scheduled necropsy Day 15 after treatment |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal 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 bw.
- Executive summary:
The acute dermal toxicity of the substance was determinated according to the OECD 402 test guideline with GLP. The dermal 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 dermal 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.