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EC number: 204-010-8 | CAS number: 112-85-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Data is from experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The study was conducted to determine the mortality, clinical sign of toxicity and histopathological effect of the given test chemical at different dose level in wistar albino rats.
- GLP compliance:
- no
- Test type:
- other: Acute Dermal Toxicity
- Limit test:
- yes
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): docosanoic acid
- Substance type: Organic
- Physical state: Solid White powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- -Source : In-bred
-Age : 8 to 10 weeks.
-Body weight range :200±20g
-Identification : By cage tag and corresponding colour body marking.
-Nutritional conditions : Animals were fasted overnight prior to test and food was offered three hours after dosing.
-Housing : Groups of two animals of same sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
-Diet : Pelleted feed
-Water : Fresh and clean water filtered through ‘Aqua Guard on line water filter’, was kept in glass bottles Ad libitum
-Acclimatization :The healthy wistar albino rats selected for study acclimatized to standard laboratory condition for period of one week under close Veterinary supervision.
-Randomization : After acclimation and Veterinary examination all the animals randomly divided into two groups and each group having five male and five female rats.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25 deg.C
- Humidity (%):40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours dark.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: distilled water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back skin of total body surface area
- % coverage: Approximate 10 percent
- Type of wrap if used: The test substance was applied uniformly over an exposed area of skin. The test compound was held in contact with the skin with an impervious dressing secured in place with an adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
- Time after start of exposure:24 hours
VEHICLE
- Amount(s) applied (volume or weight with unit):0.5 gm
- Dose preparation: Preparation of the test article was done freshly, few minutes prior to dosing. Test substance was moistened with distilled water. - Duration of exposure:
- 24 hours
- Doses:
- Group-I - 2000 mg/kg b. wt
Group-II - 2000 mg/kg b. wt - No. of animals per sex per dose:
- Group-I - 2000 mg/kg b. wt - 10 (5 male & 5 female)
Group-II - 2000 mg/kg b. wt - 10 (5 male & 5 female) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for mortality at 30 minutes time interval for first six hours on the day of test compound administration and thereafter twice a day for 14 days.
The treated animals were closely observed for clinical signs of intoxication, first 4 hours and thereafter for every 1 hrs interval for 24 hrs after dosing and twice a day for 14 days. All the rats were observed at least twice daily with the purpose of recording any symptoms of ill-health or behavioral changes. These observations included changes in skin and fur in the eyes and mucous membranes, respiratory, circulatory, central nervous and autonomous systems, somatomotor activity and behavior changes. The following clinical signs were observed in rats to characterize with erythema, hypersensitivity, edema etc.
The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).
- Necropsy of survivors performed: yes, necropsy was carried out on all the animals that died during the study or surviving animals were sacrificed at the end of the study to observe any gross pathological changes. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No incidence of mortality was observed
- Mortality:
- No incidence of mortality was observed in wistar albino rats after application of test compound. The period of application of test compound was 24 hours
- Clinical signs:
- other: The wistar albino rats treated with the test compound did not show any clinical signs of intoxication throughout the period of observation.
- Gross pathology:
- NECROPSY FINDING
EXTERNAL
Skin- Skin and hair coat was observed wet.
All external orifices- Normal
INTERNAL
Subcutaneous- No changes were observed.
Superficial and deep lymph nodes- No change in mesenteric lymph node.
ABDOMINAL CAVITY
Opening and general examination- In the abdominal cavity all the organs were present in normal position.
Spleen- No changes were recorded.
Digestive system- No gross changes were observed in stomach and intestine.
Liver and biliary ducts- No gross pathological changes were observed
Excretory system- No gross pathological changes were observed.
Adrenal- Observed normal.
Male/female genital organs – Showed normal colour, consistency and no inflammatory changes.
THORACIC CAVITY
Opening and general examination- Thoracic cavity was found to be normal without any fluid, mucous or blood etc.
Lungs- No changes were recorded.
Heart- No changes were observed in color and consistency. Heart found normal.
Thyroid- Normal in shape, size and surface.
3. CRANIAL CAVITY
Brain- Normal in shape and size. - Other findings:
- not specified
Any other information on results incl. tables
TABLE – 2
SUMMARY OF BODY WEIGHT (GM)
Group |
Animal ID |
Day 0 |
Day 7 |
% Gain/loss |
Day 14 |
% Gain/loss |
Group-I 2000 mg/kg b. wt
|
201319-1 |
200.4 |
206.9 |
3.24 |
213.4 |
6.48 |
201319-2 |
205.7 |
213.3 |
3.69 |
219.6 |
6.75 |
|
201319-3 |
202.9 |
209.4 |
3.20 |
214.1 |
6.60 |
|
201319-4 |
206.4 |
212.3 |
2.85 |
220.3 |
6.73 |
|
201319-5 |
204.9 |
211.4 |
3.17 |
219.9 |
7.31 |
|
201319-6 |
202.02 |
210.02 |
3.99 |
219.00 |
8.40 |
|
201319-7 |
200.99 |
209.98 |
4.47 |
218.89 |
8.90 |
|
201319-8 |
201.46 |
210.64 |
4.5 |
217.32 |
7.8 |
|
201319-9 |
206.56 |
217.54 |
5.3 |
221.47 |
7.2 |
|
201319-10 |
204.67 |
209.46 |
2.3 |
217.75 |
6.3 |
|
Group-II 2000 mg/kg b. wt |
201319-11 |
203.31 |
210.10 |
3.3 |
216.42 |
6.4 |
201319-12 |
194.6 |
199.3 |
2.41 |
206.8 |
6.26 |
|
201319-13 |
201.23 |
206.99 |
2.86 |
211.56 |
5.13 |
|
201319-14 |
205.41 |
210.23 |
2.34 |
218.13 |
6.19 |
|
201319-15 |
198.28 |
204.87 |
3.32 |
210.30 |
6.06 |
|
201319-16 |
201.56 |
207.12 |
2.75 |
214.05 |
6.19 |
|
201319-17 |
203.55 |
208.98 |
2.66 |
215.88 |
6.05 |
|
201319-18 |
205.4 |
211.4 |
2.92 |
214.4 |
4.38 |
|
201319-19 |
204.2 |
210.3 |
2.98 |
215.3 |
5.43 |
|
201319-20 |
203.1 |
209.4 |
3.10 |
215.2 |
5.95 |
TABLE – 3
CLINICAL SIGNS AND MORTALITY
Parameters |
Incidence of Clinical Signs Observed after Dosing on |
Mortality |
|||||||||||||||||||
Day 0 |
DAY |
||||||||||||||||||||
Min |
Hour |
||||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total |
% |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Clinical Signs- Local |
|
||||||||||||||||||||
Redness |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Pain |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Swelling |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Systemic signs |
|||||||||||||||||||||
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Group: I Limit test Dose: 2000 mg/kg b.wt
- =Observed after 24 hrs
0 = No clinical signs
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
TABLE – 3 Contd…………….
CLINICAL SIGNS AND MORTALITY
Group: II Confirmatory test Dose: 2000 mg/kg b.wt
Parameters |
Incidence of Clinical Signs Observed after Dosing on |
Mortality |
|||||||||||||||||||
Day 0 |
DAY |
||||||||||||||||||||
Min |
Hour |
||||||||||||||||||||
30 |
1 |
2 |
4 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
Total |
% |
|
Mortality (total) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/10 |
0 |
Clinical Signs- Local |
|
||||||||||||||||||||
Redness |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Pain |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Swelling |
- |
- |
- |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Systemic signs |
|||||||||||||||||||||
Clinical signs |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- =Observed after 24 hrs
0 = No clinical signs
+ = Mild
++ = Moderate
+++ = High
++++ = Severe
TABLE – 4
SUMMARY OF NECROPSY FINDINGS
S. No. |
Fate
|
Wistar albino rats |
|
Dose (mg/kg b. wt) |
|||
2000 (limit test) |
2000 (confirmatory test) |
||
1 |
Terminal sacrifice |
10/10 |
10/10 |
2 |
Found Dead |
0/10 |
0/10 |
3 |
Abnormalities detected |
0/10 |
0/10 |
TABLE – 5
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group-I (limit test) 2000 mg/kg b.wt.
Animal ID |
Fate |
Time |
Gross Findings |
201319-1 |
TS |
Day 15 |
NAD |
201319-2 |
TS |
Day 15 |
NAD |
201319-3 |
TS |
Day 15 |
NAD |
201319-4 |
TS |
Day 15 |
NAD |
201319-5 |
TS |
Day 15 |
NAD |
201319-6 |
TS |
Day 15 |
NAD |
201319-7 |
TS |
Day 15 |
NAD |
201319-8 |
TS |
Day 15 |
NAD |
201319-9 |
TS |
Day 15 |
NAD |
201319-10 |
TS |
Day 15 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD-Found dead
TABLE-5 Contd………..
INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS
Group: II(confirmatory test) Dose: 2000 mg/kg b.wt.
Animal ID |
Fate |
Time |
Gross Findings |
201319-11 |
TS |
Day 15 |
NAD |
201319-12 |
TS |
Day 15 |
NAD |
201319-13 |
TS |
Day 15 |
NAD |
201319-14 |
TS |
Day 15 |
NAD |
201319-15 |
TS |
Day 15 |
NAD |
201319-16 |
TS |
Day 15 |
NAD |
201319-17 |
TS |
Day 15 |
NAD |
201319-18 |
TS |
Day 15 |
NAD |
201319-19 |
TS |
Day 15 |
NAD |
201319-20 |
TS |
Day 15 |
NAD |
Day 0 is the day of dose administration.
TS- Terminal Sacrifice
NAD- No abnormality Detected
FD-Found dead
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based on the results obtained from present investigation, it can be concluded that the LD50 value was considered to be >2000 mg/kg bw, when Wistar albino rats treated with the test chemical applied dermally on the shaven back skin. Hence, the given test chemical is acutely non toxic.
- Executive summary:
The acute dermal toxicity study of the given test chemical was conducted according to OECD guideline 402 for testing of chemicals on Wistar albino rats. The summary of the study was as follows -
Limit Test (2000 mg/kg b.wt):
Ten healthy wistar albino rats of both sexes (ranging b.wt 200±20 gm) were selected for the study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test compound was applied dermally at the dose level of 2000 mg/kg b.wt to each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at the termination of the study. The test compound applied at the dose level of 2000 mg/kg b.wt in Wistar albino rats did not show any mortality as well as clinical signs of toxicity throughout the observation period of 14 days. The necropsy was conducted on all the animals at the end of observation period did not show any gross pathological changes.
Confirmatory Test:
After 72 hrs, confirmatory test was conducted in same species of animals to confirm result obtained from the limit test (OECD-402 guidelines for testing of chemicals). Ten healthy Wistar albino rats of both sex (ranging b.wt 200±20 gm) were selected for the study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test chemical was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at termination of the study. No mortality was recorded after administration of test compound at the dose level of 2000 mg/kg b.wt. The test compound did not elicit any clinical signs of toxicity during the entire observation period. No skin reaction was observed after 24th hrs. of patch removal. The body weight of each animal recorded on day 0, 7th and 14th showed normal increase in weight.
Based on the results obtained from present investigation, it can be concluded that the LD50 value was considered to be >2000 mg/kg bw, when Wistar albino rats treated with the test chemical applied dermally on the shaven back skin. Hence, the given test chemical is acutely non toxic.
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