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EC number: 272-195-2 | CAS number: 68783-37-9 This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid lithium salt and SDA Reporting Number: 19-006-02.
- 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- The study was performed between 21 April 2010 and 01 June 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Justification for type of information:
- See IUCLID section 13 for category and read across justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids C18-(unsaturated) lithium salts
- Cas Number:
- 502962-81-4
- IUPAC Name:
- Fatty acids C18-(unsaturated) lithium salts
- Test material form:
- solid
- Details on test material:
- - Batch number: Not reported
- Expiry date: Not reported
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Oxon, UK.
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
- Fasting period before study: Overnight fast immediately before dosing
- Housing: The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet (supplied by Harlan UK Limited, Oxon, UK) was allowed ad libitum throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: Acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 1 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: For the purpose of the study the test material was freshly prepared, as required, as a suspension in distilled water to give a dose level of 300 or 2000mg/kg bodyweight.
- Amount of vehicle (if gavage): Not stated
- Justification for choice of vehicle: Distilled water was the preferred vehicle of the test method.
- Lot/batch no. (if required): Not stated
- Purity: Not stated
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test material, 300 mg/kg was chosen as the starting dose. - Doses:
- Following a sighting test at a dose levels of 300 and 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
- No. of animals per sex per dose:
- 1 female at 300 mg/kg bw
1 female at 2000 mg/kg bw
4 females at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight.
Results and discussion
- Preliminary study:
- A sighting test at a dose levels of 300 and 2000 mg/kg bw was performed.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Signs of systemic toxicity noted were hunched posture, pilo-erection, ataxia, noisy respiration, sneezing and increased salivation. Animals appeared normal 2, 5 or 10 days after dosing.
- Gross pathology:
- No abnormalities were noted at necropsy.
Individual necropsy findings are given in Table 6 (in any other information section)
Any other information on results incl. tables
Table1 Individual Clinical Observations and Mortality Data -300mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
300 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 2 Individual Bodyweights and Bodyweight Changes -300mg/kg
Dose Level mg/kg |
Animal Number |
Bodyweight (g) at Day |
Bodyweight Gain (g) |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
1-0 Female |
180 |
202 |
212 |
22 |
10 |
Table 3 Necropsy Findings -300 mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
Table 4 Individual Clinical Observations and Mortality Data -2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
2-0 Female |
H |
H |
HPA |
HPA |
HPA |
HA |
HA |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-0 Female |
HRnS |
HRnS |
HPRn |
HPRn |
HARn |
Rn |
Rn |
RnRs |
RnRs |
RnRs |
RnRs |
RnRs |
RnRs |
0 |
0 |
0 |
0 |
0 |
|
3-1 Female |
H |
HPA |
HPA |
HP |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-2 Female |
H |
HPA |
HPA |
HA |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 Female |
H |
HA |
HA |
HA |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
H = Hunched posture
P = Pilo-erection
A = Ataxia
Rn = Noisy respiration
Rs = Sneezing
S = Increased salivation
Table 5 Individual Bodyweights and Bodyweight Changes -2000mg/kg
Dose Level mg/kg |
Animal Number |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
2-0 Female |
176 |
180 |
193 |
4 |
13 |
3-0 Female |
176 |
178 |
189 |
2 |
11 |
|
3-1 Female |
165 |
184 |
190 |
19 |
6 |
|
3-2 Female |
186 |
198 |
213 |
12 |
15 |
|
3-3 Female |
172 |
182 |
202 |
10 |
20 |
Table 6 Individual Necropsy Findings-2000mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
|
3-1 Female |
Killed Day 14 |
No abnormalities detected |
|
3-2 Female |
Killed Day 14 |
No abnormalities detected |
|
3-3 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified (EU CLP (EC) No 1272/2008) and Category 5 (UN GHS version 7, 2017)
- Remarks:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
- OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted 17 December 2001)
- Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
Method.
Following a sighting test at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further group of four fasted females was given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/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.
Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg bw were hunched posture, pilo-erection, ataxia, noisy respiration, sneezing and increased salivation. There were no signs of systemic toxicity noted in the animal treated at a dose level of 300 mg/kg bw.
Bodyweight.
All animals showed expected gains in bodyweight.
Necropsy.
No abnormalities were noted at necropsy.
Conclusion.
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
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