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EC number: 400-600-6 | CAS number: 71868-10-5 ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
- 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 key studies provided were conducted to recognised testing guidelines and with GLP certification.
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:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2180 - 2390 g
- Housing: individually
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: The substance was water moistened before application.
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patch loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg)
SCORING SYSTEM: OECD Draize Scoring System - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: One animal showed very slight erythema after one hour.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: One animal showed very slight oedema after one hour.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- The body weight development was not affected by the application of the test article.
No other reactions to treatment were recorded during the whole observation period. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material failed to induce a dermal irritation response in rabbits under the conditions of the test.
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
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2320 - 2680 g
- Housing: individually
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- The test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: OECD Scoring System
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: Slightly irritative reactions after one hour in one animal.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed.
- Remarks on result:
- other: Irritative effects were observed after one hour in one animal.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Irritation was observed after one hour
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Irritation was observed after one hour
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Remarks on result:
- other: Slight swelling was observed after one hour
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Other effects:
- In one animal the body weight decreased during the test period.
No other reactions to treatment were recorded during the whole observation period. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A GLP in vivo study was performed to assess the acute dermal irritation or corrosion potential of the test substance in White New Zealand rabbits according to the OECD guideline 404. 0.5 g of the test substance (purity: > 98 weight-%) was applied topical once on the intact skin of three female rabbits, using a patch of 6 cm2 for 4 hours. The application site was dressed semi-occlusively. The average score (24 to 72 hours) for irritation was calculated to be 0 for erythema and 0 for edema. Considering the described skin reactions, the test substance does not show a skin irritation potential under the test conditions chosen.
A supporting study to assess the acute dermal irritation or corrosion potential of the test substance was performed on 3 male and 3 female adult White New Zealand rabbits based on the proposed guidelines of the US EPA with a stringent design, namely: exposure under 24 h, occlusive conditions. An amount of 0.5 g of the test substance was applied topically once to the abraded skin of 6 rabbits. The application site was covered with an occlusive dressing for a period of 24 hours. The calculated primary irritation index was 0.05. Under the conditions of the present experiment the test substance was found to cause no irritation when applied to intact and abraded rabbit skin.
To assess the acute eye irritation potential of the test substance in vivo a GLP eye irritation test in White New Zealand rabbits was performed according to the method described in OECD guideline 405. An amount of 0.1 g of the test substance (purity: > 98 weight-%) was applied once to the eyes of three rabbits. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and iris, 0.33, 1 and 1.33 for conjunctivae redness in the three animals and 0, 0.33 and 0.33 for chemosis in the three animals. The findings were reversible in all animals within not later than 7 days after application. Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the eye.
A supporting study to assess the acute eye irritation or corrosion potential of the test substance was performed on 3 male and 3 female White New Zealand rabbits based on the proposed guidelines of the US EPA.The test material (0.1 g) was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. Eye irritation was appraised with a slit-lamp on days 1, 2, 3, 4 and 7 and scored for each rabbit. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and iris, 0.3 for conjunctivae redness and 0 for chemosis. Under the conditions of this experiment, the test material does not give indication of an irritant property to the eye.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.
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