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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 292-835-4 | CAS number: 91001-64-8
- 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
Skin irritation/corrosion rabbit, 24 hour occlusive treatment of intact or abraded skin with neat test substance (as received from the sponsor):
Intact and abraded skin: At each observation time point (0 and 48 h and 6 d post patch removal) no erythema and no edema reaction in each of 5 animals.
Eye irritation, rabbit; treatment with neat test substance (as received from the sponsor):
Mean irritation score 24, 48 and 72 h for each of 6 animals:
0.0 for corneal opacity; 0.0 for iris lesion; 2.0 for redness of conjunctivae; 1.7 to 2.7 for oedema of conjunctivae (chemosis); 1.7 for lacrimation.
Findings and gradings similar to these were recorded from 1 to 8 h post instillation and all were fully reversible, as from 5 to 6 days post instillation each treated eye was free from ocular findings.
(Local lymph node assay, mouse (Endpoint study record "7.4.1 Skin sensitisation - LLNA_mouse_GAH0129):
Group Mean Stimulation Index (SI) = 1.0, 33.9, 45.1 and 59.9 at test substance concentrations of 0 % (vehicle control), 10, 25 and 50% w/v, respectively.
Conclusion: Classification and labelling as
"irritant (Xi)" and "may cause sensitisation by skin contact (R43)" [DIRECTIVE 67/548/EEC] and
“Category 1” (Warning: May cause an allergic skin reaction)" [REGULATION (EC) 1272/2008]).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- yes
- Remarks:
- Skin examination 0 h, 48 h and 6 days after patch removal
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Number: 5 animals,
- Average bodyweight: 3 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day. - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded versus only shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of neat test substance was administered to the skin by means of a "2.5 cm2" cellulose patch.*
* Comment by the data submitter:
There is no indication in the report, whether the size of treated skin patches was inadvertently stated as only "2.5 cm2" in reality having been sized 2.5 cm x 2.5 cm (i.e. ca. 6 cm2) or whether, contrarily to the cited OECD 404 test guideline, the size of the treated skin patches was really confined to only 2.5 cm2. Regardless whether the treated skin patch was ca. 6 cm2 or only 2.5 cm2, the study results are considered to be valid for assessment. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days (i.e. the final observation time point was 6 days post patch removal)
- Number of animals:
- 5
- Details on study design:
- TEST SITE PREPARATION
Samples of 0.5 mL of the neat test substance were applied to the shaved intact and to shaved and then abraded skin of albino rabbits by means of cellulose patches. Patches were fixed with leucoplast and the whole trunk of each animal was enwrapped by a rubber cloth during the 24 hour treatment period, in order to delay evaporation of substances. From the coverage of the whole animal trunk (patches inclusive) with rubber cloth occlusive treatment was concluded by the data submitter, although the report did not specify whether this coverage was considered to be occlusive or semi-occlusive.
Two untreated skin sites (one of shaved intact skin and one of shaved and then abraded skin) served as controls. Only skin reactions different to controls were graded as positive skin reactions.
TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE
Occlusive treatment lasted 24 hours. Then the dressings were removed. There was no mentioning in the report that exposed skin patches were cleaned from residual test substance after treatment.
TIME POINTS OF SKIN EVALUATION:
The treated skin patches were evaluated 24 and 72 hours and 7 days post application (i.e. immediately and 48 hours and 6 days post patch removal). The scoring system for the grading of skin reactions is listed in Table 1 (next field below). - Irritation parameter:
- erythema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema formation was not evident
- Remarks on result:
- other: Neat test substance administered to intact skin for 24 hours
- Irritation parameter:
- edema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: edema formation was not evident
- Remarks on result:
- other: Neat test substance administered to intact skin for 24 hours
- Irritation parameter:
- erythema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema formation was not evident
- Remarks on result:
- other: Neat test substance administered to abraded skin for 24 hours
- Irritation parameter:
- edema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: edema formation was not evident
- Remarks on result:
- other: Neat test substance administered to abraded skin for 24 hours
- Irritant / corrosive response data:
- In each animal, shaved intact skin patches treated with neat test substance and shaved abraded skin patches treated with neat test substance were free from erythema, scab or edema formation at any observation time point of the study.
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Tattooed New Zealands (albino rabbit)
- Details on test animals or tissues and environmental conditions:
- - Number: 6 animals,
- Bodyweight: 2.8 to 3.2 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
Prior to dosing the animals were starved for 16 hours.
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of undiluted liquid test substance was administered into the conjunctival sac of one eye per rabbit. The contralateral eye remained untreated to serve as a control.
- Duration of treatment / exposure:
- There was no mentioning in the report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 7 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
- Observation period (in vivo):
- 7 days (i.e. the final observation time point was 7 days post instillation)
- Number of animals or in vitro replicates:
- 6 adult rabbits
- Details on study design:
- Before and after the test the eyes were evaluated for occular lesions using ultraviolet light.
The numerical scoring system listed in Table 1 in the field below was adopted. Time points of evaluation were: Pretest (prior to treatment), 1, 2, 4, 8, 24, 48, 72 and 96 hours after administration and daily thereafter until 7 days after administration. Grades attained at 24, 48 and 72 hours after administration were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal irritation or opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridal changes were not evident during the study
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #4
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #5
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #6
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- other: lacrimation score
- Basis:
- mean
- Remarks:
- over 6 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- Corneal and iridic lesions were not evident throughout the study. Conjunctival redness, grade 2, was seen in all treated eyes until 72 hours post instillation, declining in severity thereafter and having completely disappeared in all animals by 5 to 6 days post instillation. Chemosis, grade 2 or 3, was seen in all treated eyes until 48 or 72 hours post instillation, declining in severity thereafter and having completely disappeared in all animals by 5 days post instillation. In addition, lacrimation, grade 1 or 2 was recorded in all treated eyes until 72 hours post instillation. As from 5 to 6 days post instillation, each treated eye was free from ocular findings.
- Other effects:
- There was no mentioning of any other effects in the report.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In view of the absence of any effects on shaved intact and abraded skin treated for 24 hours with neat WS400109, classification regarding skin irritation or corrosion according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008] is not necessary.
The incidence and severity of chemosis and conjunctival redness attained in the in vivo eye irritation study necessitates classification of WS400109 as "irritant (Xi)" and "irritating to eyes (R36) [DIRECTIVE 67/548/EEC] and as “Category 2 (irritating to eyes)" [REGULATION (EC) 1272/2008].
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.