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EC number: 269-124-2 | CAS number: 68187-77-9
- 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
in vivo skin irritation, test 1984, NZW rabbit on analogue substance 1: not skin irritant
in vitro skin irritation on FLL sample 3, sample 4 and sample 6, OECD 431: not skin irritant
in vivo eye irritation, test 1984, on analogue substance 1: H319 cat. 2
in vitro eye irritation on FLL sample 3 and 4: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: old study, no guideline followed
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 67/548 CEE
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing:iron stainless steel cage model 1472 "tecniplast"
- Diet : pellet, ad libitum
- Water : municipal filtered water, ad libitum
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1°C
- Humidity (%): 55 ± 15%
- Air changes (per hr):8 per hour
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- one application/ 4 hours
- Observation period:
- 24, 48, 72 hours , 5, and 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: ~ 10 cm^2
- % coverage:
- Type of wrap if used:multiple foil surgical gauze (2.5 X 2.5 cm). The gauze is fixed by ipoallergenic adhesive bandage (Blenderm BM). The entire animal's trunk is protected by elastic bandage (Acrylastic Beyersdorf)
SCORING SYSTEM: according to OECD guideline 404
Erithema, Edema - Irritation parameter:
- erythema score
- Basis:
- animal: 1 and 4
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 2 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 3 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 1 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 2 and 4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 3 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested for skin irritation following method 29/7/1983 , 67/548 CEE. Under the experimental conditions the substance is not skin irritant.
- Executive summary:
The substance was tested for skin irritation following method 29/7/1983 , 67/548 CEE. Six NZW rabbits were shaved and tested with occlusive method for 4 hours. Under the experimental conditions the substance is not skin irritant.
Reference
erithema | check | 1 | 2 | 3 | 4 | 5 | 6 | mean |
24h | 1 | 2 | 2 | 1 | 2 | 2 | 1.66 | |
48h | 1 | 2 | 2 | 1 | 2 | 2 | 1.66 | |
72h | 1 | 1 | 2 | 1 | 1 | 2 | 1.33 | |
5d | 0 | 1 | 1 | 1 | 1 | 1 | 0.83 | |
7d | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
edema | check | 1 | 2 | 3 | 4 | 5 | 6 | mean |
24h | 1 | 1 | 0 | 1 | 1 | 0 | 0.66 | |
48h | 1 | 1 | 0 | 1 | 1 | 0 | 0.66 | |
72h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
5d | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
7d | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Good study, no GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: 67/548/CEE
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeding center Padre Antonio
- Weight at study initiation:2 - 3 kg
- Housing: stainless steel cage 1472 Tecniplast with autowashing (10 sec. every hour)
- Diet: full pellet, ad libitum.
- Water: municipal water filtered with Seitz filter, ad libitum.
- Acclimation period: 7 days
- Healt check: 24 hours before treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 55±15
- Air changes (per hr):8 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml/animale - Duration of treatment / exposure:
- one injection
- Observation period (in vivo):
- 1, 24, 48, 72h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: according to DAIZE test
TOOL USED TO ASSESS SCORE: fluorescein, and UV lamp (365 nm) - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 1 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 2, 3, 4 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1
- Time point:
- 24/48/72 h
- Score:
- ca. 2.66
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2 and 3
- Time point:
- 24/48/72 h
- Score:
- ca. 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4, 5 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1 and 6
- Time point:
- 24/48/72 h
- Score:
- ca. 2.6
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 4 and 5
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.6
- Max. score:
- 2
- Reversibility:
- not reversible
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested for eye irritation following 67/548/ECC method. Under the experimental conditions the conjunctivae score was > 2 and not reversible for the duration of the test for more thna 2/3 of animals.
- Executive summary:
The substance was tested for eye irritation following 67/548/ECC method. Under the experimental conditions the conjunctivae score was > 2 and not reversible for the duration of the test for more thna 2/3 of animals.
Reference
tissue | observation period | rabbit | Mean | |||||
1 | 2 | 3 | 4 | 5 | 6 | |||
Cornea | 1h | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
24h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
48h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
72h | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
7days | 1 | 1 | 1 | 0 | 1 | 0 | 0.66 | |
Iris | 1h | 0 | 0 | 0 | 0 | 0 | 0 | 0.00 |
24h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
48h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
72h | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
7days | 1 | 0 | 0 | 0 | 1 | 0 | 0.33 | |
Conjunctiva | 1h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 |
24h | 3 | 3 | 3 | 2 | 2 | 2 | 2.50 | |
48h | 3 | 2 | 2 | 2 | 2 | 2 | 2.16 | |
72h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 | |
7days | 1 | 1 | 1 | 1 | 1 | 1 | 1.00 | |
chemosis | 1h | 2 | 2 | 2 | 2 | 2 | 2 | 2.00 |
24h | 3 | 2 | 2 | 3 | 3 | 3 | 2.83 | |
48h | 3 | 2 | 2 | 2 | 2 | 3 | 2.33 | |
72h | 2 | 2 | 1 | 1 | 1 | 2 | 1.50 | |
7days | 1 | 0 | 1 | 1 | 0 | 1 | 0.66 |
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
According to the CLP Regulation (EC 1272/2008), a substance is classified as Eye irritant Cat 2 if at least in 2 of 3 tested animals, a positive response of:
1) corneal opacity ≥ 1 and/or
2) 2) iritis ≥ 1, and/or
3) conjunctival redness ≥ 2 and/or
4) conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days. Based on the results of the means calculated over 24/48/72h reported in the key study the substance is classified as H319, Category 2.
According to the CLP Regulation (EC 1272/2008), a substance is considered as skin irritant cat2 if:
1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Based on the results reported in the in vivo key study, the substance is not classified as skin irritant.
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