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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 600-735-2 | CAS number: 106276-79-3
- 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 - patch test according to AFDO (pre-GLP), rabbit: not irritating;
Eye irritation - study according to AFDO (pre-GLP), rabbit: not irritating
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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP non-guideline study, available as unpublished report, predates implementation of GLP and/or development of study guidelines, minor restrictions in design and/or reporting but otherwise adequate for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight: 1.5 - 2 kg
- Housing: single housing in V2A wire cages
- Diet: NAFAG, Gossau SO, rabbit food ad libitum
- Water: water ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and scarified
- Vehicle:
- other: PEG 400
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- The substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 animals: 3 males, 3 females
- Details on study design:
- TEST SITE
A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.
REMOVAL OF TEST SUBSTANCE
The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.
SCORING SYSTEM:
Erythema and Eschar Formation:
No erythema; 0
Very slight erythema (barely perceptible); 1
Well defined erythema; 2
Moderate to severe erythema; 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth); 4
Total possible erythema score; 4
Edema Formation
No edema; 0
Very slight edema (barely perceptible); 1
Slight edema (edges of area well defined by definite raising; 2
Moderate edema (raised approximately 1 mm); 3
Severe edema (raised more than 1 mm and extending beyond area of exposure); 4
Total possible edema score; 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scarified skin
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP non-guideline study, available as unpublished report, predates implementation of GLP and/or development of study guidelines, notable limitations in design and/or reporting. After application eye lids were held open for a few seconds instead of closed.
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Species:
- rabbit
- Strain:
- other: Russion breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single housing in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: water ad libitum
- Only rabbits showing normal ophthalmic findings were included in the test. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Eyes of 3 female animals were rinsed 30 seconds after treatment. Eyes of 3 male animals were not rinsed.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals: 3 males, 3 females
- Details on study design:
- Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three female rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.
SCORING SYSTEM: The reactions were appraised after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
Evaluation of the Eye Reactions:
Cornea:
A. Opacity-degree of density (area most dense taken for reading):
No opacity; 0
Scattered or diffuse area, details of iris clearly visible; 1
Easily discernible translucent areas, details of iris slightly obscured; 2
Opalescent areas, no details of iris visible, size of pupil barely discernible; 3
Opaque, iris invisible; 4
B. Area of cornea involved:
One quarter (or less) but not zero; 1
Greater than one quarter, but less than half; 2
Greater than half, but less than three quarters; 3
Greater than three quarters, up to whole area; 4
A X B X 5
Total maximum = 80
Iris
A. Values
Normal; 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive); 1
No reaction to light, hemorrhage, gross destruction (any or all of these); 2
A x 5
Conjunctivae:
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris):
Vessels normal; 0
Vessels definitely injected above normal; 1
More diffuse/ deeper crimson red, individual vessels not easily discernible; 2
Diffuse beefy red; 3
B. Chemosis:
No swelling; 0
Any swelling above normal (includes nictitating membrane); 1
Obvious swelling with partial eversion of lids; 2
Swelling with lids about half closed; 3
Swelling with lids about half closed to completely closed; 4
C. Discharge:
No discharge; 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals); 1
Discharge with moistening of the lids and hairs just adjacent to lids; 2
Discharge with moistening of the lids and hairs, and considerable area around the eye; 3
(A + B + C) X 2
Total maximum = 20
TOOL USED TO ASSESS SCORE: slit-lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hour - 7 days
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: Rinsed eye
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hour - 7 days
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: Rinsed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hour - 7 days
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Rinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hour - 7 days
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hour - 7 days
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hour - 7 days
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: Eyes not rinsed
- Irritant / corrosive response data:
- The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion:
In a skin irritation patch test (pre-GLP) according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), the skin irritating properties of the test substance was assessed. Therefor 6 Russian breed rabbits (3 male, 3 female) were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore, the test substance is considered as non-irritant to the skin of rabbits.
Eye irritation:
In an eye irritation test (pre-GLP; according AFDO guideline) 6 Russian breed rabbits (3 male, 3 female) amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore, the test substance is considered as non-irritant to the eye of rabbits.
Justification for classification or non-classification
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, as amended for the 13th time in Regulation (EU) 2018/1480.
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.