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EC number: 214-011-5 | CAS number: 1072-62-4
- 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: The test substance was irritating to rabbits' skin under test conditions chosen (BASF, 1980) and showed an irritating potential in an in vitro Epiderm SCT/SIT Test (according to OECD guideline and GLP, 2010).
Eye: The test substance causes severe eye damage under test conditions chosen.
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:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP and no guideline study.
- Principles of method if other than guideline:
- according to the regulation of the Department of Transportation, Fed.Reg., § 173.1200
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Mean body weight: ca. 2.8 kg
The animals were offered Ssniff K, standard diet for rabbits and guinea pigs, supplied by INTERMAST GMBH, Soest, FRG, and water ad libitum. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 g of an 80% aqueous test substance preparation
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 4
- Details on study design:
- The hair was removed from the dorsal and lateral parts of the trunk using electric clippers about 15 to 24 hours before application. Only animals with healthy and intact skin were used for the study.
The clipped dorsal skin of the rabbits was exposed to a test patch (about 2 x 2 cm) containing the test substance for 4 hours. The test patch was covered with a rubberised linen cloth that was secured in place by adhesive tape. After 4 hours the bandage was removed and the treated skin areas were washed with Lutrol or a mixture of water and Lutrol (1 : 1) and then dried with cellulose. The first findings were recorded after the bandage had been removed and then each working day. During the application the animals were restrained and did not receive any food.
Examinations:
a) Local irritation or corrosion
b) Signs of systemic toxicity
c) Necropsy of sacrificed animals - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h, 48 h
- Score:
- 2.625
- Max. score:
- 4
- Reversibility:
- other: not fully reversible within 8 days in 3 out of 4 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h, 48 h
- Score:
- 1.875
- Max. score:
- 4
- Reversibility:
- other: not fully reversible within 8 days in 1 out of 4 animals
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: parchment-like necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: parchment-like necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: spotty-necrotic skin lesion
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: within 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: parchment-like necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: parchment-like necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: spotty-necrotic skin lesion
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- After the 4-hour test substance application, initially distinct erythema and edema were observed. In the course of 8-day observation period, 2 of 4 animals showed parchment-like necrosis as a result of an irreversible skin damage. One animal showed a spotty-necrotic skin lesion. The skin findings were macroscopically confirmed by a pathologist. Parchment-like necosis are considered to present strong irritation (not corrosion).
- Interpretation of results:
- Category 2 (irritant)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic information given
- Principles of method if other than guideline:
- according to BASF-internal standard
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: corroded mucosa
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: corroded mucosa
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: corroded mucosa
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Other effects:
- Effects were not fully reversible after 8 days and the animals had developed iritis.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation:
Weight oif Evidence:
In vitro:
The potential of the test
substance to cause dermal corrosion/irritation was assessed by a single
topical application of 25 µL bulk volume (about 18 mg) of the test item
to a reconstructed three dimensional human epidermis model (EpiDerm).
For the corrosion test two EpiDerm tissue samples were incubated with
the test substance for 3 minutes and 1 hour, respectively. The
irritation test was performed with three EpiDerm tissue samples, which
were incubated with the test substance for 1 hour followed by a 42 -hour
post-incubation period. Tissue destruction was determined by measuring
the metabolic activity of the tissue after exposure/post-incubation
using a colorimetric test. The reduction of mitochondrial dehydrogenase
activity, measured by reduced formazan production after incubation with
a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan
production of the test-substance treated epidermal tissue is compared to
that of the negative control tissues. The quotient of the values
indicates the relative tissue viability.
In the EpiDerm skin corrosivity/irritation test the test substance was
not able to reduce MTT directly.
Corrosion test:The mean viability of the test-substance treated
tissues determined after an exposure period of 3 minutes was 100%, and
it was 17% after an exposure period of 1 hour.
Irritation test:The mean viability of the test-substance treated
tissues determined after an exposure period of 1 hour with about 42
hours post-incubation was 11%.
Bases in the observed results it was concluded, that the test substance
shows a skin irritation potential in the EpiDermTM skin
corrosion/irritation test under the test conditions chosen.
In vivo:
In a primary dermal irritation
study (BASF, 1980) according to the Department of Transportation, Fed.
Reg., § 173.1200 (1980), four male Vienna White rabbits were dermally
exposed to 0.5 g of an 80% aqueous test substance preparation. The test
substance was applied in a single dose (2 x 2 cm, occlusive) to the
clipped skin of the back of an experimental animal for 4 hours (test
item was washed off). Untreated skin areas served as the control. The
degree of irritation was observed after 4 hours, 1 day, 2 days and 8
days. For the evaluation of the results, the scheme was converted to the
OECD Draize schema. After the 4-hour test substance application,
initially distinct erythema and edema were observed. The mean erythema
score (24h/48h) was 2.625 and the mean edema score (24h/48h) was 1.875.
In the course of 8-day observation period, 2 of 4 animals showed
parchment-like necrosis as a result of an irreversible skin damage. One
animal showed a spotty-necrotic skin lesion. Parchment-like necrosis
present strong irritation (not corrosion).
In a primary dermal irritation study
(BASF, 1967) according to BASF-internal standard, two Vienna White
rabbits were dermally exposed to an 80% aqueous test substance
preparation. The test substance was applied in a single dose (occlusive)
to the clipped skin (back and ear) of an experimental animal for 20
hours (test item was not washed off). Untreated skin areas served as the
control. The degree of irritation was scored at 1 min, 5 min, 15 min, 24
h and 8 days. For the evaluation of the results, the BASF scheme was
converted to the OECD Draize schema. After the 20 hours application the
mean erythema score was 2 and the edema score was 3 after 24 hours.
After 8 day a severe necrosis was observed. Based on these results the
test substance is considered as a skin irritant. However, as the
exposure duration was 20 h and hence not according to current standards
and considering that exposure for 4 h resulted in largely less effects
and that an in vitro assay concluded the substance to be irritating (not
corrosive), the result of this supporting study was not considered for
classification purposes.
Eye irritation:
In a primary irritation study according to BASF-internal
standard, 50 mg of the test substance without a vehicle was instilled
into the conjunctival sac of the right eye of two Vienna White rabbits.
The left eye served as the untreated control for each rabbit. The test
substance was not washed out. animals then were observed at the
following time points: 1h, 24 h and after 8 days. For the evaluation of
the results, the BASF scheme was converted to the OECD Draize schema.
The mean cornea score was 3, the mean chemosis score was 4 and the mean
conjunctiva score was 1.5 after 24 hours. Effects were not fully
reversible after 8 days and the animals had developed iritis. Based on
these results, the test item causes severe eye damage.
Justification for classification or non-classification
The available studies are considered reliable and suitable for classification purposes under regulation 1272/2008. As a result the substance is considered to be classified and labelled as skin irritating cat. 2, H315 and causes severe eye damage cat. 1, H 318.
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