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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 259-393-4 | CAS number: 54914-37-3
- 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
- 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
Endpoint summary
Administrative data
Description of key information
The test substance showed corrosive effects on the skin of male and female rabbits. For skin corrosive substances it is assumed that the substance will also cause severe damages of the eyes. However, in a in vivo study on eye irritation (Hüls 1985) the test substance, tested with one undiluted administration of 0,1 m3 to eyes or eyelid sac of male and female rabbits showed slightly irritating effects (OECD 405, 1981).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-01-18 to 2016-01-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- July 28, 2015, adopted
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM Minimum Performance Standards: In Vitro Membrane Barrier Test Systems for Skin Corrosion, June 23, 2003
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM Recommended Performance Standards for in vitro Test Methods for Skin Corrosion (May 2004)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in vitro
- Details on test animals or test system and environmental conditions:
- Test Kit
Name: Corrositex™
Supplier: Transia GmbH, 35510 Butzbach, Germany
Lot No.: CT120314 - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- - Test item: 500 μL of the neat test item were dispensed directly atop the bio-barrier.
- Positive control: Sulfuric acid (95-97%) was used as positive control. 500 μL were applied to only one bio-barrier.
- Negative control: Citric acid (10% (w/v) solution in deionised water) was used as negative control. 500 μL were applied to only one bio-barrier.
- Reference Item: 10% acetic acid (v/v) will be used as reference item. 500 μL were applied to four bio-barriers. - Duration of treatment / exposure:
- Time until observable change in CDS solution: 0 - 240 min
As result from the categorisation test, the test item were applied per bio-barrier for 1 hour - Observation period:
- 1 hour
- Details on study design:
- Preparation of the Bio-barrier
- One day prior to testing the bio-barrier matrix was prepared.
- The bio-barrier powder was solved in the bio-barrier diluent and heated for 20 ± 2 minutes at 68 – 70 °C in a water bath under continuous stirring.
- The temperature did not exceed 70 °C. The mixture was allowed to cool in the turned-off water bath for another 10 minutes.
- The mixture was then filled into the membrane holders (200 μL per membrane holder). Air bubbles were avoided.
- The filled membrane holders were sealed with parafilm and were stored at 2 – 8 °C until further use.
Qualify Test
- In order to test whether the test system is suitable for the test item and reference item, 150 μL of the test item were applied into the
“Qualify Test Vial”. The vial was shaken until the solution appeared homogenous, and incubated for 1 minute. Afterwards, a change in consistency
was noted.
Categorisation Test
- In the categorisation test the observation period of the test item and reference item after application to the bio-barrier was determined:
• Category 1: observation period after application will be 4 hours
• Category 2: observation period after application will be 1 hour
- Approximately 150 μL of the test item were applied into the “Category A Vial” as well as into the “Category B Vial”. The vials were shaken until the
solution appeared homogenous. After 1 minute no colour change was monitored.
- Based on the colour change obtained, a test item is assigned to a category. If an intense colour change (similar to the category 1 colour chart) is
observed in “Category A Vial” or in “Category B Vial” the test item is assigned to category 1. If a less intense colour change (similar to the category 2 colour chart) is observed in “Category A Vial” or in “Category B Vial” the test item will be assigned to category 2. If no colour change is observed in
either of the vials, a confirmation test is conducted. For the confirmation test two drops of the confirm reagent are added to the “Category B Vial”.
The vial was shaken for 5 seconds. The colour of the solution matched one of the colours shown in the accompanying colour chart, confirming that
the test item is a category 2 substance.
Classification Test
- 11 vials containing the CDS were pre-warmed to room temperature.
- 4 vials each were used for quadruplicate measurement of the test item and reference item, the vial labelled (+) was used for the positive control
(single measurement), and the vial labelled (-) was used for the negative control (single measurement).
- The vial labelled C was used as colour reference for the CDS.
- Applications of the test item, reference item and the controls were performed staggered to ensure accurate reaction times to be recorded.
- The prepared bio-barriers were placed atop the CDS vials (not longer than 2 min prior to application) and 500 μL of the test item or controls,
respectively, were applied per bio-barrier for 1 hour was a result from the categorisation test.
- The time interval of the possible colour change or precipitation in the CDS solution was recorded in the raw data file. - Irritation / corrosion parameter:
- other: Colour change
- Value:
- > 60
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not corrosive to skin.
- Executive summary:
This in vitro study was performed to assess the corrosive potential of test item by means of the in vitro Membrane Barrier Test for
Skin Corrosion (OECD TG 435) using the Corrositex™ test kit.
Following an initial determination of the compatibility of the test item with the test system (qualify test) and a test system-specific categorisation (categorisation test), 500 μL of the test item were applied on quadruplicate bio-barriers for the classification test. The
bio-barriers were placed atop vials containing the chemical detection system (CDS). The time needed to corrode the bio-barrier and to induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.
Additionally to the test item a reference item was tested.
No change of colour of the CDS reagent after treatment of the bio-barriers with the test item was observed after the 60 minutes time interval.
A change of colour of the CDS reagent after treatment of the bio-barriers with the reference item could be observed in the interval from 30 to 60 minutes.
The test item as well as the negative and the positive controls fulfilled the acceptance criteria for the test system.
According to the classification criteria given in "overall remarks" the test item was, therefore, classified as not corrosive.
The reference item was classified as corrosive (UN GHS subcategory 1C or C; Reg. (EC) No. 1272/2008).
In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not corrosive to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-29 to 1985-06-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- - Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male and female
- Weight at study initiation: 2.2 - 2.6 kg - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hour
- Observation period:
- - Examination time points: 1, 24, 48, 72 hours, 5, 7, 9, 12, and 14 days after patch removal; evaluation based on readings 1-4
- Number of animals:
- 6 (3 males, 3 females)
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with warm water
- Post exposure period: 14 days - Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 1, 24, 48, and 72 hours
- Score:
- 6.21
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 4.0
- Edema: 2.2
- necroses: within 4 hours, not within 3 minutes
REVERSIBILITY: not reversible - Other effects:
- general sequence: reddish brown, sometimes green discoloration with white flecks on part of the application area (1-72 hours); induration (24-72 hours); eschar formation, partly detaching (days 5-14), formation of scars (end of study)
- Conclusions:
- The substance crosslinking agent
1,3,3 -trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine, tested with one undiluted application of 0,5 cm3 was corrosive to the skin of male and female rabbits (OECD 404, 1981). - Executive summary:
The test substance tested with one undiluted application of 0,5 cm3was corrosive to the skin of male and female rabbits (OECD 404, 1981).
Referenceopen allclose all
RESULTS AND DISCUSSION
Qualify Test (Test Item)
The test item induced a physical change (precipitation) in the qualify test after 1 minute incubation. Since a physical change (precipitation) was visible in the “Qualify Test Vial”, the test item was considered to be suitable for the next step.
Qualify Test (Reference Item)
The reference item induced a change in colour in the qualify test after 1 minute incubation. Since a change in colour was visible in the “Qualify Test Vial”, the test item was considered to be suitable for the next step.
Categorisation Test (Test Item)
The test item did not induce a change in colour neither Category A vial nor in the Category B vial after 1 minute incubation. A confirmation experiment was performed by adding the confirm reagent to the Category B vial. This induced a change in colour to grey. Therefore, the test item was classified as category 2.
Categorisation Test (Reference Item)
The reference item did not induce a change in colour neither Category A vial nor in the Category B vial after 1 minute incubation. A confirmation experiment was performed by adding the confirm reagent to the Category B vial. This induced a change in colour to yellow. Therefore, the test item was classified as category II.
Classification Test
Test Group |
Time Interval of Color Change |
UN GHS Prediction
|
||
Negative Control |
|
Non-corrosive
|
||
Positive Control |
53 seconds
|
Corrosive Sub-category 1A
|
||
Reference Item |
> 30 – 60 minutes
|
Corrosive Sub-category1C
|
||
Test Item |
> 60 minutes
|
Non corrosive
|
Discussion
According to Sponsor’s information there is an animal study available with test substance. Based on this study results test item has to be classified as corrosive. The design of this study could not distinguish between subcategories 1B and 1C. Therefore, a reference item, with well-known Category (1C) was determined in addition in the present study.
The test item and the reference item passed the qualify test and were considered as suitable for testing with the Corrositex™ test kit.
In the categorisation test the test item and the reference item did not induce a colour change in the category A or in the category B vial after 1 minute incubation. A confirmation experiment was performed by adding the confirm reagent to the Category B vial. This induced a change in colour after 5 seconds incubation. The test item was classified according to category 2.
500 μl of the test item and the reference item were applied on quadruplicate bio-barriers for the classification test. The bio-barriers were placed atop vials containing the CDS reagent. The time needed to corrode the bio-barrier and induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.
500 μL of the negative control (10% citric acid) were placed atop one bio-barrier and the colour change of the CDS reagent was monitored up to 60 minutes.
500 μL of the positive control (Sulfuric acid 95-97%) was placed atop one bio-barrier and the colour change of the CDS reagent was monitored.
The negative control did not induce a change in the colour of the CDS reagent after 60 minutes. The positive control showed a distinct change in the colour of the CDS reagent in the time interval of 0 – 3 minutes. These results ensured the validity of the test.
A change of colour of the CDS reagent after treatment of the bio-barriers with the test item could not be observed after 60 minutes. According to the classification criteria given in "overall remarks" the test item was classified as Non Corrosive.
A change of colour of the CDS reagent after treatment of the bio-barriers with the reference item could be observed in the interval from 30 to 60 minutes. According to the classification criteria given in "overall remarks"
the reference item was classified as corrosive (GHS Cat 1C).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-05-29 to 1985-06-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- - Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male and female
- Weight at study initiation: 2.0 - 2.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- Postexposure observation period: 12 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: rinsed after (see exposure time)
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 5, 7, 9, and 12 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: according to scoring system
- Score:
- 18.21
- Max. score:
- 110
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: REVERSIBILITY: complete in 12 days except for alopecia on the margin of the lower eyelid of one animal
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.72
- Iris: 0.33
- Conjunctivae (Redness): 2.06
- Conjunctivae (Chemosis): 0.61
- Overall irritation score: 18.21/110
DESCRIPTION OF LESIONS: transient reddening of parts of the iris in the females
REVERSIBILITY: complete in 12 days except for alopecia on the margin of the lower eyelid of one animal - Conclusions:
- The crosslinking agent
1,3,3 -trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine
(VESTAMIN A 139), tested with one undiluted administration of 0,1 m3 to eyes or eyelid sac of male and female rabbits showed slightly irritating effects (OECD 405, 1981). - Executive summary:
The test substance tested with one undiluted administration of 0,1 m3to eyes or eyelid sac of male and female rabbits showed slightly irritating effects (OECD 405, 1981).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The test substance tested with one undiluted application of 0,5 cm3 was strongly irritating to the skin of male and female rabbits (OECD 404, 1981).
In a study on eye irritation the test substance tested with one undiluted administration of 0,1 m3 to eyes or eyelid sac of male and female rabbits showed only slightly irritating effects (OECD 405, 1981).
Justification for classification or non-classification
According to criteria of EC Regulation 1272/2008, the test substance is corrosive to skin (Skin Corr. 1 C) and slightly irritating to the eyes (Eye Irrit. 2).
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.