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EC number: 225-896-2 | CAS number: 5137-55-3
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
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- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- To determine the dermal reaction profile of Methyltrioctylammonium chloride in Sprague Dawley rats
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyltrioctylammonium chloride
- EC Number:
- 225-896-2
- EC Name:
- Methyltrioctylammonium chloride
- Cas Number:
- 5137-55-3
- Molecular formula:
- C25H54ClN
- IUPAC Name:
- methyltrioctylammonium chloride
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material: Methyltrioctylammonium chloride
- IUPAC name: Methyltrioctyl ammonium chloride
- Molecular formula: C25H54ClN
- Molecular weight: 404.162 g/mole
- Smiles :[N+](CCCCCCCC)(CCCCCCCC)(CCCCCCCC)C.[ClH-]
- Inchl: 1S/C25H54N.ClH/c1-5-8-11-14-17-20-23-26(4,24-21-18-15-12-9-6-2)25-22-19-16-13-10-7-3;/h5-25H2,1-4H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Viscous liquid (yellow to yellowish brown)
- Purity: not less than 90.0%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Methyltrioctylammonium chloride
- IUPAC name: Methyltrioctyl ammonium chloride
- Molecular formula: C25H54ClN
- Molecular weight: 404.162 g/mole
- Smiles :[N+](CCCCCCCC)(CCCCCCCC)(CCCCCCCC)C.[ClH-]
- Inchl: 1S/C25H54N.ClH/c1-5-8-11-14-17-20-23-26(4,24-21-18-15-12-9-6-2)25-22-19-16-13-10-7-3;/h5-25H2,1-4H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Viscous liquid (yellow to yellowish brown)
- Manufacturing Date: 1-8-2017
- Expiry Date : 1-7-2020
- Consistency: Liquid
- Batch Number: 217MAU0019
- Safety Precautions: Safety precautions included use of protective clothing, gloves, masks and eye protection (glasses).
- Storage Condition: Ambient Temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: Females were nulliparous and non-pregnant
- Age at study initiation: Young adult (8 to 10 weeks old) female rats were used.
- Weight at study initiation: The weight range of approximately 221.6 to 235.3 grams at initiation of dosing
Body weights at the start :
Female
Mean : 226.90 g (= 100 %)
Minimum : 221.6 g (- 2.34 %)
Maximum : 235.3 g (+ 3.70 %)
Total No. of animals : 5
- Identification: Each rat was individually identified by the cage number.
- Fasting period before study: No data available
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
Temperature (°C): 19.0 to 22.5 degree centigrade
- Humidity (%): 55.3% to 58.8%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.
IN-LIFE DATES: Experimental Starting Date: 06-03-2018
Experimental Completion Date: 29-03-2018
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Dose range finding study: 200, 1000, 2000 mg/kg
Main study: 2000 mg/kg - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- Dose Range Finding Study: 3
Main Study: 2 - Details on study design:
- TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure:Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : Dermal reaction was observed daily for study period of 14 days.
SCORING SYSTEM: Draize Method
OTHER OBSERVATIONS
Viability: Twice daily.
Clinical Observations and General Appearance: Animals were observed for clinical signs, mortality, until sacrifice. Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.The observations included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction: Dermal reaction was observed daily for study period of 14 days.
Body weights: Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology: Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology: No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1,#2,#3
- Time point:
- other: 11 days
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- dose range finding study
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2,#3
- Time point:
- other: 11 days
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- dose range finding study
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 12 days
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- main study
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 10 days
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 13 days
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 12 days
- Score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Dose Range Finding Study:
Group I : Animal treated at the dose level of 200 mg/kg body weight resulted in slight to moderate oedema, thickening of skin, desquamation and slight to moderate erythema at the site of application. The site of application was free of any skin reaction at the termination of study period.
Group I : Animal treated at the dose level of 1000 mg/kg body weight resulted in slight to severe oedema, thickening of skin, desquamation and slight to severe erythema at the site of application. The site of application was free of any skin reaction at the termination of study period.
Group I : Animal treated at the dose level of 2000 mg/kg body weight resulted in slight to severe oedema, thickening of skin, desquamation and slight to severe erythema at the site of application. The site of application was free of any skin reaction at the termination of study period
Main Study:
Group II : Animals treated at the dose level of 2000 mg/kg body weight resulted in slight to severe oedema, thickening of skin, desquamation and slight to severe erythema at the site of application. The site of application was free of any skin reaction at the termination of study period. - Other effects:
- Clinical Signs of Toxicity and Mortality:
Sex : Female
Dose Range Finding Study:
Group I : Animal treated at the dose level of 200 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. The animal survived through the study period of 14 days.
Group I : Animal treated at the dose level of 1000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. The animal survived through the study period of 14 days.
Group I : Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. The animal survived through the study period of 14 days.
Main Study:
Group II : Animals treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. All animals survived through the study period of 14 days.
Body Weight:
Sex : Female
Dose Range Finding Study:
Group I (200 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.46% and 8.48% respectively.
Group I (1000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.18% and 7.28% respectively.
Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 4.74% and 10.56% respectively.
Main Study:
Group II (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 3.38% and 6.47% respectively.
Gross Pathological Findings :
Gross pathological examination did not reveal any abnormalities in animals from 200 mg/kg, 1000 mg/kg and 2000 mg/kg dose groups from dose range finding study and main study sacrificed terminally.
Any other information on results incl. tables
Summary of Evaluation of Dermal Reaction
Laboratory Test Item Code :TAS/122/068
Test System : Sprague Dawley Rat
Sex : Female
Finding Study:
Group No. |
Dose mg/kg |
Total Number of Animals |
Animal Nos. |
Dermal Reaction |
Period of signs in days From – to |
Period of signs in days From – to |
I |
200 |
1 |
1 |
Erythema |
Slight |
Day 10 – Day 11 |
Moderate |
Day 8 – Day 9 |
|||||
Oedema |
Slight |
Day 3, Day 8 – Day 10 |
||||
Moderate |
Day 4 |
|||||
Severe |
Day 5 |
|||||
Thickening of skin |
- |
Day 2 - Day 6 |
||||
Desquamation |
- |
Day 6 - Day 7 |
Group No. |
Dose mg/kg |
Total Number of Animals |
Animal Nos. |
Dermal Reaction |
Period of signs in days From – to |
Period of signs in days From – to |
I |
1000 |
1 |
2 |
Erythema |
Slight |
Day 11 – Day 12 |
Moderate |
Day 9 – Day 10 |
|||||
Severe |
Day 8 |
|||||
Oedema |
Slight |
Day 2, Day 8 – Day 11 |
||||
Moderate |
Day 3 |
|||||
Severe |
Day 4 – Day 5 |
|||||
Thickening of skin |
- |
Day 2 - Day 6 |
||||
Desquamation |
- |
Day 6 - Day 7 |
Group No. |
Dose mg/kg |
Total Number of Animals |
Animal Nos. |
Dermal Reaction |
Period of signs in days From – to |
Period of signs in days From – to |
I |
2000 |
1 |
3 |
Erythema |
Slight |
Day 11 – Day 13 |
Moderate |
Day 9 – Day 10 |
|||||
Severe |
Day 7 – Day 8 |
|||||
Oedema |
Slight |
Day 7 – Day 11 |
||||
Moderate |
Day 3 |
|||||
Severe |
Day 4 – Day 5 |
|||||
Thickening of skin |
- |
Day 1 - Day 5 |
||||
Desquamation |
- |
Day 6 |
Main Study:
Group No. |
Dose mg/kg |
Total Number of Animals |
Animal Nos. |
Dermal Reaction |
Period of signs in days From – to |
Period of signs in days From – to |
II |
2000 |
1 |
4 |
Erythema |
Slight |
Day 11 – Day 12 |
Moderate |
Day 10 |
|||||
Severe |
Day 8 – Day 9 |
|||||
Oedema |
Slight |
Day 8 – Day 10 |
||||
Moderate |
Day 3 |
|||||
Severe |
Day 4 – Day 6 |
|||||
Thickening of skin |
- |
Day 1 - Day 6 |
||||
Desquamation |
- |
Day 7 |
Group No. |
Dose mg/kg |
Total Number of Animals |
Animal Nos. |
Dermal Reaction |
Period of signs in days From – to |
Period of signs in days From – to |
II |
2000 |
1 |
5 |
Erythema |
Slight |
Day 12 – Day 13 |
Moderate |
Day 9 – Day 11 |
|||||
Severe |
Day 7 – Day 8 |
|||||
Oedema |
Slight |
Day 7 – Day 12 |
||||
Moderate |
Day 1 – Day 2 |
|||||
Severe |
Day 3 – Day 5 |
|||||
Thickening of skin |
- |
Day 1 - Day 5 |
||||
Desquamation |
- |
Day 6 |
Individual Animal - Evaluation of Dermal Reaction
Laboratory Test Item Code :TAS/122/068
Test System : Sprague Dawley Rat
Sex : Female
Finding Study:
Group : I Dose : 200 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1 |
2* |
3* |
4* |
5* |
6* |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
D |
D |
2 |
2 |
1 |
1 |
0 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
1 |
2 |
3 |
D |
D |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
Group : I Dose : 1000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1 |
2* |
3* |
4* |
5* |
6* |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
D |
D |
3 |
2 |
2 |
1 |
1 |
0 |
0 |
|
Oedema |
0 |
0 |
1 |
2 |
3 |
3 |
D |
D |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
Group : I Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1* |
2* |
3* |
4* |
5* |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
D |
3 |
3 |
2 |
2 |
1 |
1 |
1 |
0 |
|
Oedema |
0 |
0 |
0 |
2 |
3 |
3 |
D |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
Main Study:
Group : II Dose : 2000 mg/kg body weight
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1* |
2* |
3* |
4* |
5* |
6* |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
4 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
D |
3 |
3 |
2 |
1 |
1 |
0 |
0 |
|
Oedema |
0 |
0 |
0 |
2 |
3 |
3 |
3 |
D |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
Animal |
Dermal |
D A Y S |
||||||||||||||
No. |
Reaction |
0 |
1* |
2* |
3* |
4* |
5* |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
5 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
D |
3 |
3 |
2 |
2 |
2 |
1 |
1 |
0 |
|
Oedema |
0 |
2 |
2 |
3 |
3 |
3 |
D |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
* = Thickening of skin
D = Desquamation
Summary of Clinical Signs of Toxicity and Mortality
Finding Study:
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
200 |
No clinical signs observed |
1 |
1 |
Day 0 - Day 14 |
0/1 |
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
1000 |
No clinical signs observed |
1 |
2 |
Day 0 - Day 14 |
0/1 |
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
I |
2000 |
No clinical signs observed |
1 |
3 |
Day 0 - Day 14 |
0/1 |
Main Study:
Group No. |
Dose mg/kg |
Observed Signs |
Total Number of Animals |
Animal Nos. |
Period of signs in days From - to |
Mortality |
II |
2000 |
No clinical signs observed |
2 |
4, 5 |
Day 0 - Day 14 |
0/2 |
Mean Body Weight and Percent Body Weight Gain (g)
Finding Study:
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
200 |
Mean |
221.6 |
233.7 |
5.46 |
240.4 |
2.87 |
8.48 |
± SD |
- |
- |
- |
- |
- |
- |
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
1000 |
Mean |
223.8 |
235.4 |
5.18 |
240.1 |
2.00 |
7.28 |
± SD |
- |
- |
- |
- |
- |
- |
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
I |
2000 |
Mean |
223.5 |
234.1 |
4.74 |
247.1 |
5.55 |
10.56 |
± SD |
- |
- |
- |
- |
- |
- |
Main Study:
Group No. |
Dose (mg/kg body weight) |
|
Body weight Day 0 |
Body weight Day 7 |
% body weight gain day 0-7 |
Body weight Day 14 |
% body weight gain day 7- 14 |
% body weight gain day 0- 14 |
II |
2000 |
Mean |
232.80 |
240.65 |
3.38 |
247.85 |
2.99 |
6.47 |
± SD |
3.54 |
1.91 |
0.75 |
2.33 |
0.15 |
0.61 |
Summary of Gross Pathological Findings
Finding Study:
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
200 |
1 |
TS |
No abnormality detected |
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
1000 |
2 |
TS |
No abnormality detected |
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
I |
2000 |
3 |
TS |
No abnormality detected |
Main Study:
Group No. |
Dose mg/kg |
Animal Numbers |
Animal Fate |
Gross Pathological Findings |
II |
2000 |
4, 5 |
TS |
No abnormality detected |
TS = Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Slight to severe oedema, thickening of skin followed by desquamation resulting in slight to severe erythema at the site of application was observed in all animals from dose range finding study.Slight to severe oedema, thickening of skin followed by desquamation resulting in slight to severe erythema at the site of application was observed in all animals from main study. The site of application was free of any skin reaction at the termination of study period.
Eventhough the effects were reversible till 14 days, since they were observed in all the tested animals, Methyltrioctylammonium chloride can be considered to be corrosive to skin.
It can be further classified under the category "Category 1" as per CLP regulation. - Executive summary:
A study was designed and conducted to determine the acute dermal toxicity profile of Methyltrioctylammonium chloride (CAS No. 5137-55-3)in Sprague Dawley rats. 5 Young adult (8 to 10 weeks old) female Sprague Dawley rats were used for the study.
Approximately 24 hours before application, the hair of each rat was closely clipped from the trunk (dorsal surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 10% of the body surface area.
The test item was applied directly onto the exposed skin of the animal, taking care to spread the test item evenly over the entire area of approximately 10% of the total body surface area or as much of the area as can reasonably be covered. The test item was held in contact with the skin using a porous gauze dressing and non irritating tape around the animal to cover the exposure site for first 24 hours exposure period. Elizabethan collar was placed on each animal for first 24 hours after application of the test item. These collars prevent ingestion of test item.
Following 24 hours of exposure, the wrapping was removed and the test site wiped free of excess test item. Distilled water was used to remove residual test item.
In the dose range finding study a single dose of 200 mg/kg body weight of the test item was administered to 1 female animal. No death or clinical signs of toxicity was observed during first 48 hours, hence, additional 1 female animal was administered with the dose of 1000 mg/kg body weight. Administration of 1000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours, hence, additional 1 female animal was administered at the dose of 2000 mg/kg body weight. Administration of 2000 mg/kg body weight did not reveal any clinical signs of toxicity or death during first 48 hours.
Animals from dose range finding study treated at the dose levels of 200 mg/kg, 1000 mg/kg and 2000 mg/kg exhibited normal body weight gain and no clinical signs of toxicity or mortality during the study period of 14 days. As the dose range finding study revealed no mortality or clinical signs at the maximum dose of 2000 mg/kg, hence, the main study was initiated with two additional animals. The animals were administered with a dose of 2000 mg/kg body weight in sequential manner at 48 hours intervals.
Animals from main study treated at the dose level of 2000 mg/kg exhibited normal body weight gain and no clinical signs of toxicity or mortality during the study period of 14 days.
Gross pathological examination did not reveal any abnormalities attributable to the treatment.
Slight to severe oedema, thickening of skin followed by desquamation resulting in slight to severe erythema at the site of application was observed in all animals from dose range finding study.Slight to severe oedema, thickening of skin followed by desquamation resulting in slight to severe erythema at the site of application was observed in all animals from main study. The site of application was free of any skin reaction at the termination of study period.
Eventhough the effects were reversible till 14 days, since they were observed in all the tested animals, Methyltrioctylammonium chloride can be considered to be corrosive to skin.
It can be further classified under the category "Category 1" as per CLP regulation.
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