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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 915-926-9 | 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:
- 2012-05-09 to 2012-06-19
- 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
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N-dibutyloleamide and oleic acid, sulphated, sodium salts
- EC Number:
- 915-926-9
- Molecular formula:
- C18H34Na2O6S + C26H52NNaO5S
- IUPAC Name:
- N,N-dibutyloleamide and oleic acid, sulphated, sodium salts
- Test material form:
- liquid
- Details on test material:
- The water content of the actual test item was 57.6% (w/w); the water content of the REACH registration substance was analytically determined to be 3.8% (w/w).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Wistar (RccHan:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200 g, and were eight to twelve weeks of age. The weight variation did not exceed ± 20 % of the mean weight for each sex.
The animals were housed in suspended solid floor polypropylene cages furnished with wood flakes. The animals were housed individually during the 24 Hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 % respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The calculated volume of test item, as received, was applied as evenly as possible to an area of shorn skin (approximately 10 % of the total body surface area) using a graduated syringe.
- Duration of exposure:
- 24 hours
- Doses:
- Using available information on the toxicity of the test material, a single group of animals was treated as follows:
Dose Level (mg/kg/bw): 4717* (* - equivalent to 2000 mg active ingredient/kg bodyweight)
Specific Gravity: 1.031
Dose Volume (mL/kg/bw): 4.58
Number of Rats: Male (5) / Female (5) - No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- no statistical analysis was performed
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 717 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95 % confidence limits not reported
- Mortality:
- There were no deaths
- Body weight:
- other body weight observations
- Remarks:
- Two males and two females showed bodyweight loss during the first week but expected gain in bodyweight during the second week. The remaining animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal Reactions
Signs of dermal irritation noted were very slight to well defined erythema, very slight to slight oedema, blanching of the skin, light brown discolouration of the epidermis, haemorrhage of dermal capillaries, loss of skin elasticity and flexibility, crust formation, small superficial scattered scabs, hardened light brown coloured scab, scab lifting at edges to reveal dried blood, scab lifting to reveal glossy skin, scab cracking, scab undulating and glossy skin. Adverse reactions prevented accurate evaluation of oedema at the test sites of three males. Adverse reactions prevented accurate evaluation of erythema and/or oedema at the test sites of three females
Any other information on results incl. tables
Evaluation of Data
Data evaluations included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test item was made.
Table 1: Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Initiation of Exposure (Hours) |
Effects Noted After Initiation of Exposure (Days) |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
4717* |
1 – 0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 – 1 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1 – 2 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1 – 3 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1 – 4 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 – 0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 – 1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 – 2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 – 3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 – 4 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*= Equivalent to 2000 mg active ingredient/kg bodyweight
0= No signs of systemic toxicity
Table 2: Individual Bodyweights and Weekly Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Change (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
4717* |
1-0 Male |
264 |
276 |
304 |
12 |
28 |
1-1 Male |
287 |
299 |
334 |
12 |
35 |
|
1-2 Male |
258 |
272 |
297 |
14 |
25 |
|
1-3 Male |
331 |
330 |
352 |
-1 |
22 |
|
1-4 Male |
385 |
375 |
394 |
-10 |
19 |
|
2-0 Female |
216 |
217 |
227 |
1 |
10 |
|
2-1 Female |
207 |
202 |
208 |
-5 |
6 |
|
2-2 Female |
212 |
211 |
216 |
-1 |
5 |
|
2-3 Female |
200 |
206 |
211 |
6 |
5 |
|
2-4 Female |
202 |
204 |
206 |
2 |
2 |
*= Equivalent to 2000 mg active ingredient/kg bodyweight
Table 3: Individual Necropsy Findings
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
4717* |
1-0 Male |
Killed Day 14 |
No abnormalities detected |
1-1 Male |
Killed Day 14 |
No abnormalities detected |
|
1-2 Male |
Killed Day 14 |
No abnormalities detected |
|
1-3 Male |
Killed Day 14 |
No abnormalities detected |
|
1-4 Male |
Killed Day 14 |
No abnormalities detected |
|
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
2-3 Female |
Killed Day 14 |
No abnormalities detected |
|
2-4 Female |
Killed Day 14 |
No abnormalities detected |
*= Equivalent to 2000 mg active ingredient/kg bodyweight
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information: The acute dermal median lethal dose (LD50) of the test item was found to be greater than 4717 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 4717 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted)
Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008
Method: A group of ten animals (five males and five females) was given a single, 24 hour, semi‑occluded dermal application of the undiluted test item to intact skin at a dose level of 4717 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality: There were no deaths.
Clinical Observations: There were no signs of systemic toxicity.
Dermal Irritation: Signs of dermal irritation noted were very slight to well‑defined erythema, very slight to slight oedema, blanching of the skin, light brown discolouration of the epidermis, haemorrhage of dermal capillaries, loss of skin elasticity and flexibility, crust formation, scabbing, scab lifting to reveal dried blood or glossy skin, scab cracking, scab undulating and glossy skin.
Bodyweight: Two males and two females showed bodyweight loss during the first week but expected gain in bodyweight during the second week. The remaining animals showed expected gains in bodyweight over the study period.
Necropsy: No abnormalities were noted at necropsy.
Conclusion: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 4717 mg/kg bodyweight.
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.