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EC number: 700-040-5 | CAS number: 674347-28-5
- 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:
- The study was performed between 02 December 2008 and 30 December 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Lithium naphthalene-2-carboxylate
- EC Number:
- 700-040-5
- Cas Number:
- 674347-28-5
- Molecular formula:
- C11 H7 Li O2
- IUPAC Name:
- Lithium naphthalene-2-carboxylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 8 to 12 weeks.
- Weight at study initiation: 162-210 g (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 and for approximately three to four hours after 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): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Set to achieve limits of 19 to 25°C
- Humidity (%): Set to achieve limits of 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): The lighting was controlled by a time switch to give twelve hours continous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 0 To: Day 14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
Dose level 2000 mg/kg - Concentration 200 mg/ml
Dose level 300 mg/kg - Concentration 30 mg/ml
- Amount of vehicle (if gavage): The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing.
- Justification for choice of vehicle: For the purpose of the study the test material was freshly prepared, as required, as a suspension in arachis oil BP. Acrachis oil BP was used because the test material did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION: All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe.
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 2000 mg/kg was choosen as the starting dose. - Doses:
- 2000 mg/kg and 300 mg/kg.
- No. of animals per sex per dose:
- 2000 mg/kg - A total of five female animals were treated at a dose level of 2000 mg/kg.
300 mg/kg - A total of five female animals were treated at a dose level of 300 mg/kg. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made at 1/2, 1, 2 and 4 hours after dosing and then daily for up to 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 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
Results and discussion
- Preliminary study:
- Using available information on the toxicity of the test material 2000mg/kg was chosen as the starting dose. In the absence of mortality two days after dosing, at a dose level of 2000mg/kg, an additionla group of animals was treated.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Remarks on result:
- other: 95% CL not stated.
- Mortality:
- Dose Level - 2000 mg/kg
One animal was found dead three to four hours after dosing. Two animals were killed in extremis one or four days after dosing.
Dose Level - 300 mg/kg
There were no deaths. - Clinical signs:
- Dose Level - 2000 mg/kg
Signs of systemic toxicity noted were hunched posture, lethargy, ataxia, decreased respiratory rate, laboured respiration, tiptoe gait, dehydration, pilo-erection, loss of righting reflex, hypothermia and emaciation.
Surviving animals appeared normal six days after dosing.
Dose Level - 300 mg/kg
Signs of systemic noted during the day of dosing in one animal were hunched posture, lethargy and pilo-erection. No other signs of systemic toxicity were noted during the observation period. - Body weight:
- Dose Level - 2000 mg/kg
The surviving animals showed expected gains in bodyweight over the observation period.
Dose Level - 300 mg/kg
All animals showed expected gains in bodyweight over the observation period. - Gross pathology:
- Dose Level - 2000 mg/kg
Abnormalities noted at necropsy of animals that died or were killed in extremis during the study were abnormally red lungs, dark liver or patchy pallor of the liver, dark kidneys and gaseous stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Dose level - 300 mg/kg
No abnormalities were noted at necropsy. - Other findings:
- None.
Any other information on results incl. tables
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rate was estimated to be in the range of 300 - 2000 mg/kg bodyweight.
Table1 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 |
1-0 Female |
0 |
HLARd |
HARd |
H |
0 |
0 |
H |
HLAWt |
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||
2-0 Female |
HLA |
HLARd |
HLARd |
HLARdRl |
RrHoDh |
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
2-1 Female |
HA |
HLARd |
HLARd |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||
2-2 Female |
0 |
HLARd |
HLARd |
HA |
HA |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||||||||||||||
2-3 Female |
HA |
HA |
HA |
HA |
HA |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table2 Individual Bodyweights and Bodyweight Changes -2000mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight (g) |
Bodyweight Gain (g) During Week |
|||||||||||
0 |
7 |
14 |
1 |
2 |
|||||||||||
2000 |
1-0 Female |
200 |
- |
- |
146 |
- |
- |
||||||||
2-0 Female |
162 |
- |
- |
150 |
- |
- |
|||||||||
2-1 Female |
167 |
- |
- |
162 |
- |
- |
|||||||||
2-2 Female |
188 |
199 |
212 |
|
11 |
13 |
|||||||||
2-3 Female |
184 |
197 |
217 |
|
13 |
20 |
-
Table3 Individual Necropsy Findings -2000mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
||||
2000 |
1-0 Female |
Killedin extremisDay 4 |
Liver: patchy pallor Stomach: gaseous |
||||
2-0 Female |
Killedin extremisDay 1 |
Liver: patchy pallor |
|||||
2-1 Female |
Found dead Day 0 |
Lungs: abnormally red Liver: dark Kidneys: dark |
|||||
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|||||
2-3 Female |
Killed Day 14 |
No abnormalities detected |
Table4 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 |
3-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-1 Female |
0 |
HL |
HLP |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table5 Individual Bodyweights and Bodyweight Changes-300mg/kg
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
300 |
3-0 Female |
169 |
193 |
217 |
24 |
24 |
4-0 Female |
183 |
200 |
217 |
17 |
17 |
|
4-1 Female |
165 |
203 |
209 |
38 |
6 |
|
4-2 Female |
197 |
203 |
216 |
6 |
13 |
|
4-3 Female |
210 |
235 |
249 |
25 |
14 |
Table6 Individual Necropsy Findings-300mg/kg
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
300 |
3-0 Female |
Killed Day 14 |
No abnormalities detected |
4-0 Female |
Killed Day 14 |
No abnormalities detected |
|
4-1 Female |
Killed Day 14 |
No abnormalities detected |
|
4-2 Female |
Killed Day 14 |
No abnormalities detected |
|
4-3 Female |
Killed Day 14 |
No abnormalities detected |
0= No signs of systemic toxicity
H = Hunched posture
L = Lethargy
A = Ataxia
Rd = Decreased respiratory rate
Rl = Laboured respiration
Wt = Tiptoe gait
Dh = Dehydration
P = Pilo-erection
Rr = Loss of righting reflex
Ho = Hypothermia
Em = Emaciation
X = Animal dead
X* = Animal killedin extremis
-= Animal dead
0= No signs of systemic toxicity
H = Hunched posture
L = Lethargy
P = Pilo-erection
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rate was estimated to be in the range of 300 - 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 Commision Directive 2004/73/EC
Method.
Following a sighting test at a dose level of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 300 mg/kg bodyweight/ Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
One animal treated at a dose level of 2000 mg/kg was found dead and two animals treated at a dose level of 2000 mg/kg were killed in extremis during the study. There were no deaths noted at a dose level of 300 mg/kg.
Clinical Observations.
Signs of systemic toxicity noted in animals treated at a dose level of 2000 mg/kg were hunched posture, lethargy, ataxia, decreased respiratory rate, laboured respiration, tiptoe gait, dehydration, pilo-erection, loss of righting reflex, hypothermia and emaciation. Signs of systemic toxicity noted in one animal treated at a dose level of 300 mg/kg were hunched posture, lethargy and pilo-erection.
Bodyweight.
Surviving animals showed expected gains in bodyweight.
Necropsy.
Abnormalities noted at necropsy of animals that died or were killed in extremis during the study were abnormally red lungs, dark liver or patchy pallor of the liver, dark kidneys and gaseous stomach. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Conclusion.
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight.
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