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EC number: 415-490-5 | CAS number: 141773-73-1 HELVETOLIDE
- 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).
- Respiration irritation: no information.
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 1994-04-26 to 1994-04-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 404 and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- no data on the age of animals at study initiation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on the age of animals at study initiation
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Program (Inspection date: 1992-10-27)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Farms (UK) Limited, Froxfield, Hamshire.
- Age at study initiation: no data
- Weight at study initiation: 3.5, 3.7 and 3.9 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC standard rabbits pellets, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C.
- Humidity (%): 43-73 % with the exception of one occasion when the recorded relative humidity exceeded the protocol specific upper limit. This deviation is considered not to have affected the outcome of the study.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- 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:
- 3 females
- Details on study design:
- Initially, one animal was dosed in a preliminary screen to estimate the potential irritancy of the test article. Twenty four hours after patch removal a further 2 animals were dosed.
TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 2.5 cm square
- Type of wrap if used: surgical lint held in position with "Elastoplast" elastic adhesive bandage 7.5 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale (according to OECD guideline No. 404) - Irritation parameter:
- erythema 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:
- 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:
- One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time.
At the 24 hour observation, the treated skin site on all 3 animals was free of signs of irritation and remained so at the 48 and 72 hour examination. - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.
- Executive summary:
In a dermal irritation study performed similarly to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted ST 06 C 93 was dermally applied on the shaved skin of the dorsal surface of the trunk of 3 females 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 h after the removal of the patch.
The mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.
One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time. No signs of irritation were observed at 24, 48 and 72 hours.
Therefore, ST 06 C 93 does not require a classification as irritant to the skin according to the 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: Irritant/corrosive response data for 3 animals 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 |
0.0 / 2.0 / 2.0 |
1.0 / 0.0 / 1.0 |
24 h |
0.0 / 0.0 / 0.0 |
0.0 / 0.0 / 0.0 |
48 h |
0.0 / 0.0 / 0.0 |
0.0 / 0.0 / 0.0 |
72 h |
0.0 / 0.0 / 0.0 |
0.0 / 0.0 / 0.0 |
Average 24h, 48h, 72h |
0.0 / 0.0 / 0.0 |
0.0 / 0.0 / 0.0 |
Reversibility*) |
- |
- |
Average time (day) for reversion** |
- |
- |
*) 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
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 1994-05-31 to 1994-06-04
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no data on the age of animals at test initiation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- no data on the age of animals at test initiation
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP compliance programme (inspection date: 1992-10-27)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Farms (UK) Limited, Froxfield, Hampshire
- Age at study initiation: no data
- Weight at study initiation: 3.2, 4.3 and 4.3 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC Stanrab, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C.
- Humidity (%): 39-64 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The eye was not rinsed after the instillation of the test item.
- Observation period (in vivo):
- Examination made 1, 24, 48 and 72 hours following instillation
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- One animal was dosed in a preliminary screen to assess the potential irritancy of the test material. At the 24 hour examination, a further 2 rabbits were dosed.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: Draize scale (according to the OECD guideline No. 405)
TOOL USED TO ASSESS SCORE: standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour) - 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, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- Slight conjunctival hyperaemia in all 3 animals one hour after dosing, and, in 2 animals, a slight discharge from the treated eye were the only signs of irritation observed during the study.
- Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The calculated mean individual score for each individual lesion within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for chemosis, redness, discharge, iris and corneal lesions
- Executive summary:
In an eye irritation study performed similarly to the OECD guideline No. 405, and in compliance with GLP, 0.1 mL of undiluted ST 06 C 93 was instilled into the right eye of 3 female New Zealand White Rabbits. The eyes were not rinsed after the instillation of the test item. The left eye of each rabbit served as control. 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.
Slight conjunctival hyperaemia in all 3 animals one hour after dosing, and, in 2 animals, a slight discharge from the treated eye were the only signs of irritation observed during the study.
The calculated mean individual score for each individual lesion within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for chemosis, redness, discharge, iris and corneal lesions.
Under the test conditions, ST 06 C 93 is not classified as irritating to eyes according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
Reference
Table 7.3.2/1: Individual irritant/corrosive response data at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
1 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 0 / 0 |
1 / 0 / 1 |
24 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
48 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
72 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Average 24, 48, 72 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Reversibility*) |
- |
- |
- |
- |
- |
- |
Average time (unit) for reversion |
- |
- |
- |
- |
- |
- |
*) 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 (Toxicol, 1994, rel. 1). This dermal irritation study was performed similarly to the OECD guideline No. 404, and in compliance with GLP. The mean individual scores calculated within 3 scoring times (24, 48 and 72 hours) for were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema. One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time. No signs of irritation were observed at 24, 48 and 72 hours. The test material does not require classification for skin irritation.
Eye irritation:
A key study was identified (Toxicol, 1994, rel. 1). This eye irritation study was performed similarly to the OECD guideline No. 405, and in compliance with GLP. Slight conjunctival hyperaemia in all 3 animals one hour after dosing, and, in 2 animals, a slight discharge from the treated eye were the only signs of irritation observed during the study. The calculated mean individual score for each individual lesion within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for chemosis, redness, discharge, iris and corneal lesions. The test material does not require classification for eye irritation.
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 data no self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS.
No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.
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