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EC number: 213-979-6 | CAS number: 1070-70-8
- 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: corrosive (BASF, 1979)
Eye: corrosive (BASF, 1978)
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
- 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: M. Gaukler, Offenbach
- Weight at study initiation: about 3 kg
- Diet: ad libitum (Ssniff K; supplying company: Intermast GmbH, Soest)
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 1 hour (2 animals, one male and one female) and 4 hours (2 animals both male)
- Observation period:
- 8 days; reading:
(4 hours exposure): 4 hours, 1 day, 4 days and 8 days after the end of the exposure
(1 hour exposure): 1 hour, 1 day, 2 days, 8 days after the end of the exposure - Number of animals:
- 2 animals exposed for 1 hour, 2 other animals for 4 hours
- Details on study design:
- TEST SITE
- Area of exposure: trunk
- coverage: 2 x 2 cm
REMOVAL OF TEST SUBSTANCE
- Washing with lutrol or a water/lutrol mixture (1+1)
- Time after start of exposure: 1 and 4 hours after application
SCORING SYSTEM:
similar to the one described in 404 OECD guideline - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 48 hours
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 hour exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 48 hours
- Score:
- 3.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 hour exposure
- Other effects:
- 4h: Necrosis detected in both animals, though in one animal reduced to scaling at the end of the observation period.
1h: Scaling at the end of the obervation period. No necrosis occured. - Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Guideline:
- other: Draize Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 12 (6 intact skin, 6 abraded skin)
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch x 1 inch - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
- Remarks on result:
- other:
- Remarks:
- intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 2.75
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 72 hours
- Remarks on result:
- other:
- Remarks:
- intact skin
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Undiluted test substance (about 0.5 ml) was applied on the shaved backs or ears. Application time was 1, 5, 15 min (only back skin) and 20 hours under occlusive conditions. After the application time, the skin was washed with water which contained a mild detergent (Lutrol). The animals were observed for 8 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- undiluted test substance (ca. 0.5 ml)
- Duration of treatment / exposure:
- Exposure was 1, 5, 15 min and 20 hours.
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
TEST SITE
- Area of exposure: shaved back of the animals
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: occlusive dressing; not further specified
REMOVAL OF TEST SUBSTANCE
After the application time, the skin was washed with water which contained a mild detergent (Lutrol).
SCORING SYSTEM:
similar to the one described in OECD 404 guideline- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 20h exposure
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 20h exposure
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 15 min exposure
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks:
- scaling remained
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 15 min exposure
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- irritant after exposure for 1-15min.
Necrosis occured after exposure times of 20h - Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
Referenceopen allclose all
Draize scores of individual animals:
1 hour exposure |
time |
animal 1 |
animal 2 |
erythema |
1 h |
2 |
2 |
24 h |
2 |
2 |
|
48 h |
3 |
3 |
|
8 d |
2 |
2 |
|
edema |
1 h |
2 |
2 |
24 h |
2 |
4 |
|
48 h |
3 |
4 |
|
8 d |
2 |
2 |
4 hours exposure |
time |
animal 1 |
animal 2 |
|
erythema |
4 h |
3 |
3 |
|
24 h |
3 |
3 |
||
4 d |
4 |
3 |
#1: necrosis | |
8 d |
4 |
4 |
#1: scaling, #2: necrosis |
|
edema |
1 h |
4 |
3 |
|
24 h |
4 |
4 |
||
4 d |
2 |
3 |
||
8 d |
2 |
3 |
rabbit number |
intact skin |
rabbit number |
abraded skin |
||
24 hours |
72 hours |
24 hours |
72 hours |
||
A-B |
A-B |
A-B |
A-B |
||
6792 |
4-4 |
4-2 |
6786 |
4-3 |
4-3 |
6793 |
4-3 |
4-2 |
6787 |
4-3 |
4-3 |
6794 |
4-3 |
4-3 |
6788 |
4-4 |
4-2 |
6795 |
4-3 |
4-2 |
6789 |
4-4 |
4-2 |
6796 |
4-3 |
4-3 |
6790 |
4-4 |
4-2 |
6797 |
4-3 |
4-2 |
6791 |
4-4 |
4-2 |
average: |
7.2 |
6.3 |
average: |
7.7 |
6.3 |
Primary Irritation Index: 6.9
A = erythema
B = edema
Descriptions from original report were translated into Draize Scores by registrant
Erythema | |||
Exposure time | Effects after | Animal #1 | Animal #2 |
1 min | 24h | 3 | 2 |
8 days | 0 | 0 | |
5 min | 24h | 3 | 2 |
8 days | 0 (scaling) | 0 (scaling) | |
15 min | 24h | 3 | 3 |
8 days | 0 (scaling) | 0 (scaling) | |
20h | 24h | 3 | 3 |
8 days | necrosis | necrosis | |
20h (ear) | 24h | 4 | 4 |
8 days | necrosis | necrosis |
Edema | |||
Exposure time | Effects after | Animal #1 | Animal #2 |
1 min | 24h | 2 | 0 |
8 days | 0 | 0 | |
5 min | 24h | 2 | 2 |
8 days | 0 (scaling) | 0 (scaling) | |
15 min | 24h | 2 | 2 |
8 days | 0 (scaling) | 0 (scaling) | |
20h | 24h | 4 | 4 |
8 days | necrosis | necrosis | |
20h (ear) | 24h | 2 | 2 |
8 days | necrosis | necrosis |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
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:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - Observation period 7 days;
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animals are caged individually and receive no hay or other extraneous material that might enter the eyes .
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animals
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material .
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- In general the techniques of tests as published by the FDA of the United States (Fed . Reg . 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet . Industr . 71 (1952) 36) were followed . Six New Zealand White albino rabbits were used . The animals were caged individually and receive no hay or other extraneous material that might enter the eyes . The eyes of the animals were examined before testing and only those animals without observable eye defects were used . One tenth of a milliliter of the test substance was allowed to fall on the everted lower lid of one eye of each rabbit ; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material . The other eye remained untreated and served as a control . The eyes were not washed following instillation, and the animals were released immediately .
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- other: day 7: one animal had Draize score 1; all other 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
Reference
Draize scores of individual animals
|
time |
animal 1 |
animal 2 |
animal 3 |
animal 4 |
animal 5 |
animal 6 |
corneal opacity |
24 h |
2 |
1 |
1 |
1 |
1 |
1 |
48 h |
1 |
1 |
1 |
1 |
1 |
2 |
|
72 h |
2 |
1 |
1 |
2 |
2 |
2 |
|
7 d |
1 |
3 |
0 |
2 |
3 |
3 |
|
iris |
24 h |
1 |
1 |
1 |
1 |
1 |
1 |
48 h |
0 |
0 |
0 |
1 |
1 |
1 |
|
72 h |
0 |
1 |
0 |
1 |
1 |
1 |
|
7 d |
0 |
0 |
0 |
0 |
0 |
1 |
|
conjunctiva erythema/edma redness / chemosis |
24 h |
2/4 |
2/3 |
2/3 |
2/3 |
2/3 |
2/3 |
48 h |
3/4 |
2/2 |
2/3 |
2/2 |
2/2 |
2/2 |
|
72 h |
2/3 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
|
7 d |
2/2 |
2/2 |
1/0 |
2/2 |
2/2 |
2/2 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
In a study to assess skin irritation / corrosion 2 rabbits each were exposed to the 0.5ml of the undiluted test substance for either 1h or 4h under occlusive conditions (BASF 1979). After exposure for 1h, mean values for erythema and edema (24/ 48h) were 2.5 and 3.25, respectively. At the end of the 8h observation period, scaling was still observed, but no necrosis occured. After an exposure time of 4h, the mean values were 3 for erythema and 4 for edema. Necrosis was detected in both animals, but in one animal this finding was reduced to scaling at the end of the observation period. Despite the harsh occlusive conditions and the fact that full thickness necrosis was not confirmed, it is still proposed to classify the substance as skin corrosive.
In a second study, the shaved skin of 6 rabbits was treated with 0.5ml of the undiluted test substance for 24h under occlusive conditions (TNO 1978). Erythema and Edema scores were 2.75 and 4 (mean values over all animals within the first 72h). After one week necrosis was observed at the application sites. The edges of the scabs showed slight signs of healing. This study confirms corrosive properties of the test substance after longer exposure times.
In a third study, 0.5ml of the undiluted test substance was occlusively applied for 1, 5, 15min, or 20h to the backs of 2 rabbits each, or for 20h to the ears of 2 rabbits. As observed in the previous studies, shorter exposure times (1, 5, 15min) led to irritation in the first days after exposure. At the end of the 8 -day observation period, scaling was still seen in some of the animals. The longer exposure time of 20h led to necrosis of the back and ears in all animals.
Eye irritating properties were examined by instillation of 0.1ml of the undiluted test substance into the eyes of 6 New Zealand White rabbits. The procedure generally followed OECD guideline 405, but the animals were only observed for 7 days and the substance was not washed out. The average scores (24 -72h after installation) were 1.3 for corneal opacity, 0.7 for iritis, 2.1 for conjunctival redness, and 2.6 for chemosis. With the exception of iritis and chemosis in single animals, effects did not lessen until day 7. Corneal opacity even worsened in most animals and reached a score of 3 in 3/6 rabbits. Based on that, reversibility within 21 days is thought to be unlikely.
In a supporting study, the lower amount of 0.05ml was placed in the eyes of two rabbits. After strong signs of irritation on the first days after exposure, alterations subsided until only single spots of corneal opacity were observed in one animal on day 12, which are expected to be fully reversible, if the rabbits had been observed for 21 days. Consequently, the lower amount of 0.05ml causes no irreversible damage.
Justification for classification or non-classification
After occlusive exposures for up to 1h, severe irritation of the skin, but no necrosis was observed. Longer exposure times (4h to 20h) led to destruction of the skin. Consequently, the substance needs to be classified as Skin Corr. Cat. 1C according to Regulation EC No. 1272/2008 (CLP). It should be noted that the substance is legally classified as skin corrosive cat. 1B.
Installation of 0.1ml into the eyes of rabbits led to irreverible damage. Thus the substance is also classified to cause damage to the eye, cat. 1.
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