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EC number: 942-754-1 | CAS number: -
- 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: not irritating (OECD 404, GLP, K, rel. 1)
Eye irritation: not irritating (OECD 405, GLP, K, rel. 1)
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
- Study period:
- From 1990-02-28 to 1990-03-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 404 (1981) and in compliance with GLP. 4. Initial and final body weights were not reported. However this was not considered to affect the reliability of this study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- body weights not reported
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarpoley, Cheshire
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet (e.g. ad libitum): Standard Rabbit Diet ad libitum (supplied by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): mean 42 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1990-02-22 To: 1990-03-03 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: the patch was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elsatic Bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with water dampened tissues
- Time after start of exposure: 4 hours
SCORING SYSTEM: OECD recommended scoring system - Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material induced a slight irritation being reversible within 48 h.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS. - Executive summary:
In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was dermally applied on the clipped skin of the dorsal surface of the trunk of 3 New Zealand White rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours.
Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch.
The mean scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.0/0.33 for erythema and 0.0/0.0/0.0 for oedema.
Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.
Therefore the test material does not require a classification as irritant to the skin according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
Reference
Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test
Score at time point / Reversibility |
Erythema Max. score 4 |
Oedema Max. score 4 |
1 h |
0/1/1 |
0/0/1 |
24 h |
0/0/1 |
0/0/0 |
48 h |
0/0/0$ |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0/0.0/0.33 |
0.0/0.0/0.0 |
Reversibility*) |
c |
- |
Average time (day) for reversion** |
48 h |
|
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
**): correspond to the last day for which skin irritation signs in the last animal were observed
$= Dryness
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
- Study period:
- From 1989-02-10 to 1989-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 405 and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf, Switzerland
- Age at study initiation: M: 15 weeks; F: 16 weeks
- Weight at study initiation: M: 2.7 kg; F: 2.6-2.9 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, Batch 42/88 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): community tap water from Itingen ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:1989-02-10 To: 1989-02-21 - Vehicle:
- other: undiluted or in Neantine
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Left eye: 0.1 g (undiluted) / Right eye: 0.1 mL (diluted into 30 % in Neantine) - Duration of treatment / exposure:
- Eyes were not rinsed
- Observation period (in vivo):
- Eyes were observed 1, 24, 48, 72 hours and 7 days after administration
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure:
SCORING SYSTEM: Draize scale according to the OECD test guideline No. 405
TOOL USED TO ASSESS SCORE: slit-lamp and diagnostic-lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- See Table 7.3.2/1
- Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of undiluted Fixambrene was instilled into the left eye of 3 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The left eye of each rabbit was instilled with 0.1 mL Fixambrene diluted at 30 % in Neantine. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
The calculated mean score for each individual lesion for each animal treated with undiluted Fixambrene within 3 scoring times (24, 48 and 72 h) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions.
The effects observed were all reversible within 7 days.
Under the test conditions, Fixambrene is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Reference
Table 7.3.2/1: Mean irritant/corrosive response data of each animal at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea opacity(/4) |
Iris (/2) |
Conjunctivae |
|
Redness (/3) |
Chemosis (/4) |
|||
1 h |
0/0/0 |
0/0/0 |
2/2/2 |
1/0/1 |
24 h |
0/0/0 |
0/0/0 |
1/1/2 |
0/0/1 |
48 h |
0/0/0 |
0/0/0 |
0/0/2 |
0/0/1 |
72 h |
0/0/0 |
0/0/0 |
0/0/1 |
0/0/0 |
Mean 24-48-72 hrs |
0.0/0.0/0.0 |
0.0/0.0/0.0 |
0.33/0.33/1.67 |
0.00/0.00/0.67 |
Reversibility*) |
- |
- |
c. |
c. |
Average time (unit) for reversion |
|
|
7 days |
72 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A key study was identified (Inveresk, 1990, rel 1). In this dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, undiluted test material was dermally applied on the skin of 3 rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours.
The mean scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.0/0.33 for erythema and 0.0/0.0/0.0 for oedema. Very slight erythema and very slight oedema were noted 1 h after patch removal in one rabbit. Erythema (score 1) persisted until 24 h with dryness noted after 48 h. One rabbit showed very slight erythema 1 h after patch removal but this was quickly reversible by 24 h. No skin reactions were noted in the third rabbit.
Under the test conditions, the test material is not considered as a skin irritant.
Eye irritation:
A key study was identified (RCC, 1989, rel. 1). In this eye irritation study performed according to the OECD guideline No. 405, and in compliance with GLP, 0.1 g of test material was instilled into the eye of 3 rabbit. The left eye of each rabbit was instilled with 0.1 mL test substance diluted at 30 % in Neantine. The eyes were not rinsed after instillation of test material.
The calculated mean score for each individual lesion for each animal treated with undiluted test material within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.0/0.0/0.67 for chemosis; 0.33/0.33/1.67 for redness; 0.0/0.0/0.0 for iris and corneal lesions. The effects observed were fully reversible within 7 days.
Under the test conditions, the test material is not considered as irritating to eyes.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available information no additional self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS.
No data was available on respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory tract irritation.
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