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EC number: 264-780-6 | CAS number: 64338-16-5
- 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:
There is one fully reliable study available on the skin irritancy potential. The test item was tested for its skin irritant properties using 6 Albino Himalayan rabbits. The study was performed equivalent to OECD Guideline 404. 500 mg of the test item were applied to the clipped skin of each rabbit. After 24 h post-application the occlusive covering was removed and the rating for erythema/edema formation was performed 24, 48 and 72 hours after application. With reference to the scores the test item is t classified as "non-irritant" (EU CLP and UN GHS: No Category).
Eye:
There are two reliable studies available on the eye irritancy potential. In the course of both studies the test item was tested for its eye irritant properties in 6 Albino Himalayan rabbits. The studies were performed equivalent to OECD Guideline 405. Effects on conjunctivae (redness and swelling) as well on cornea and iris were observed in all animals. These signs were not reversible within the observation period.
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:
- May 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 h exposure instead of 4 h
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guideline §1500.41 Federal register 38, No. 187, 27.09.1973, p 27019
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG own breed
- Strain: Albino Himalayan, Hoe:HIMK(SPFWiga)
- Weight at study initiation: 1,5-2,5 kg
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Housing: single cages
Inlife data: from 20.03. to 23.03.1979 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of pure substance (moistened with 0.9 % NaCl solution) was applied
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 hours post application
48 hours post application
72 hours post application - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: 100 %
The substance was applied over the whole surface of a 2.5 cm2 gauze patch. The patches were fixed with adhesive tape to the prepared skinarea (ca. 18 cm2) and then covered with an occlusive polyethylene foil and further fixed with an elastic bandage (Elastoplast).
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 (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
For each animal the rating for Erythema and eschar formation as well as for Oedema formation was added after 24 and 72 hours. The sum of all values of all animals was calculated and divided by the number of animals and the factor of 4. The classification was conducted according to following evaluation classes:
0.0-0.5..........non irritant
0.6-3.0..........slightly irritant
3.1-5.0..........moderately irritant
5.1-8.0..........severely irritant - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effect
- Irritant / corrosive response data:
- No erythema/edema observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- With reference to the reported scores (mean score of 6 animals (erythema): 0; mean score of 6 animals (edema): 0) and the absence of effects the test item has not to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
The test substance is considered as not irritant under the conditions of this Patch-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:
- from 1979-03-20 to 1979-03-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no recovery period
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guideline Ferderal Register 38, No. 187, p. 27019, 27.9.1973
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- performed before GLP implementation
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG own breed
- Strain: Albino Himalayan, Hoe:HIMK(SPFWiga)
- Weight at study initiation: 1,5-2,5 kg
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water ad libitum
ENVIRONMENTAL CONDITIONS
- Housing: single cages
Inlife phase: from 20.03. to 23.03.1979 - Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 drops - Duration of treatment / exposure:
- 24 hours, thereafter, the treated eyes were rinsed with physiol. saline.
- Observation period (in vivo):
- Observation at 1, 7, 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- Left eye of each 6 rabbits was treated with 0.1 g test substance. The right eyes were not treated and used as controls.
24 hours after treatment the treated eyes were rinsed with physiol. saline.
The irritation score were determined at observation times of 1,7,24,48 and 72 hours according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (FDA, Austin, Texas, p51, 1975).
At 48 and 72 hours the eyes were also examined after instillation of one drop of 0.01 % fluorescein-sodium solution.
SCORING SYSTEM:
A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, 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, ulzeration ..............................................................................4
B. Affected area
1 = punctiform up to 1/4 but not 0
2 = more than 1/4 up to 1/2
3 = more than 1/2 up to 3/4
4 = more than 3/4 up t o 4/4
a = A x B x 5 (max 80)
IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2
b = Value x 5 (max. 10)
CONJUNCTIVAE
A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3
B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4
C. Secretion
No secretion......................................................................................................................0
Any secretion above normal...........................................................................................1
Secretion with wetting of palpebra and hair close to palpebra.................................2
Secretion with wetting of palpebra, hair and considerable area around eyes........3
c = (A+B+C) x 2 (max. 20)
For each animal the ratings for cornea (a), iris (b) and conjunctivae (c) were added for the respective time of observation. For each time of observation the mean value was calculated for all animals. The highest determined irritation score for any time of observation was used for classification according following evaluation classes:
0-10..........non irritant
11-25.......slightly irritant
26-56.......moderately irritant
57-110.....severely irritant - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48h, 72h
- Max. score:
- 95
- Reversibility:
- not specified
- Remarks on result:
- other: scores of 95 corresponds to "severly irritant"
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24-72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 24-72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 24-72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: mean value over 24-72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 h
- Remarks on result:
- other: mean value over 24-72 h
- Irritant / corrosive response data:
- The test substance is "severly irritating", the highest obtained scores being 95 for the reading time 48h and 72h.
Furthermore, 4 of 6 animals had a mean cornea score >/= 3. Iris scores of 2 were reached by all test animals except one. There was no reversibility observed within the 72 h recovery period. - Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item induced severe ocular lesions in rabbits which were irreversible within the observation period. Therefore, the substance has to be classified as follows:
- 67/548/EEC: R41
- 1272/2008/EC:Irreversible effects on the eye ( Category 1) / H318 - Executive summary:
The test item was tested for its eye irritant properties in 6 Himalyan rabbits.The study was performed equivalent to OECD Guideline 405. Effects on cornea, conjunctivae (redness and swelling) and iris were observed in all animals after application. These signs were not reversible within 72h.
With reference to the reported scores and the irreversibility of the observed effects the test item has to be classified as severely irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC):
- 1272/2008/EC:Irreversible effects on the eye ( Category 1) / H318
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin:
With reference to the reported results of an in vivo skin irritation study the test substance has not to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Eye:
With reference the reported scores and the irreversibility of the observed effects the test substance has to be classified as irritant to the eyes (irreversible effects on the eye; Category 1 / H318) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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.
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