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EC number: 294-785-9 | CAS number: 91770-03-5
- 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 corrosion/irritation in vivo
The test material was not found to be corrosive or irritant to skin (OPPTS 870.2500).
Eye damage/irritation in vivo
The test material was not found to cause serious eye damage or eye irritation (equivalent or similar to 16 CFR 1500.42).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2000 - 7 November 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: ca. 3 months Animals born on 2000-07-15
- Weight at study initiation: 2.0 - 2.7 kg
- Housing: Suspended wire cages, 1 rabbit/cage
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Quarantine period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled environment, but no information provided
- Humidity (%): controlled environment, but no information provided
- Air changes (per hr): controlled environment, but no air change information provided
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 2000-10-24 To: 2000-11-07 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL/rabbit (2.5 x 2.5 cm area)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 rabbits ( 2 males, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: 4 ply surgical gauze patch secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With distilled water on removal of wrapping.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Erythema was barely perceptible at 60 minutes following patch removal, well defined at 24 and 48 hours, well defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Oedema was barely perceptible at 60 minutes following patch removal, well defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well defined on day 7 and absent by day 14.
- Other effects:
- There were no abnormal systemic signs noted during the observation period.
Bodyweight changes were normal. - Interpretation of results:
- not classified
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
- Executive summary:
Test Guidance
In accordance with EPA guideline OPPTS 870.2500
Method and Material
Three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction.
Results
Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 14 September 1982 - 20 October 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- GLP-like (QA signature), guideline study with 24 hour exposure and termination at 72 hours without evidence of reversibility
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.41 Federal Hazardous Substances Act
- Principles of method if other than guideline:
- Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24h. Treated areas were examined at 24h after treatment and scoring using the Draize method was done at 72h after treatment.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: no data available
- Type of wrap if used: Gauze patch covered with an impervious material
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable
SCORING SYSTEM: Draize method - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Other effects:
- No data
- Interpretation of results:
- not classified
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
- Executive summary:
Test Guidance
Skin irritation study performed by a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations.
Method and Material
Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Results
Very slight to well-defined erythema and edema formation was observed at the intact and abraded sites of all animals at 24 hours. At 72 hours well-defined to moderate/severe erythema was observed at the intact and abraded sites of all animals and very slight to well-defined edema was observed at intact sites and well-defined to moderate/severe edema was observed at abraded sites of all animals. There was no evidence of reversibility over the limited timeframe of the study.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
Referenceopen allclose all
Table 1: Dermal observations, body weights and systemic observation
Rabbit Ear-tag |
F5983 |
F5990 |
F5955 |
Sex |
M |
F |
M |
Pre-test body weight (kg) |
2.7 |
2.0 |
2.7 |
72 h weight (kg) |
2.7 |
2.0 |
2.8 |
Day 7 weight (kg) |
2.7 |
2.1 |
2.8 |
Terminal body weight (kg) |
2.8 |
2.2 |
2.8 |
Time after patch removal |
Erythema and Eschar Formation |
||
60 mins |
1 |
1 |
1 |
24 hours |
2 |
2 |
2 |
48 hours |
2 |
2b* |
2 |
72 hours |
3 |
2p |
2p |
7 days |
1f* |
4f* |
0f |
14 days |
0* |
0* |
0 |
|
Oedema |
||
60 mins |
1 |
1 |
1 |
24 hours |
2 |
2 |
3 |
48 hours |
1 |
2 |
2 |
72 hours |
1 |
2 |
2 |
7 days |
1 |
2 |
0 |
14 days |
0 |
0 |
0 |
|
Systemic Observations |
||
60 mins |
A |
A |
A |
24 hours |
A |
A |
A |
48 hours |
A |
A |
A |
72 hours |
A |
A |
A |
7 days |
A |
A |
A |
14 days |
A |
A |
A |
A = normal, b = brown areas, f = flaking skin, p = pale areas, *= reclipped
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 September 1982 - 20 October 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP-like study (QA signature)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.42 Federal Hazardous Substances Act
- GLP compliance:
- yes
- Remarks:
- GLP-like study (QA signature)
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Housing: Stainless steel with elevated wire mesh flooring; 1 rabbit per cage
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1982-09- 13 To: 1982 -09-20 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Eyes were not rinsed throughout study
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- Six rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not appliacable
SCORING SYSTEM: Draize method - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not classified
- Conclusions:
- In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
- Executive summary:
Test Guidance
Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,
Method and Material
0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.
Results
No irritation was observed in any animal at any observation period.
Conclusion
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion/irritation in vivo
Key study
The key study was performed in accordance with EPA guideline OPPTS 870.2500. Three New Zealand White rabbits were dosed dermally with 0.5 mL of the test material to one intact site per rabbit. Semiocclusive wrapping was applied for 4 hours after which the wrapping was removed and the test site washed. Dermal reactions were scored using the Draize method at 60 minutes, 24, 48 and 72 hours and on days 7 and 14 of the observation period. The skin was also evaluated for ulceration, necrosis or evidence of skin destruction.
Erythema was barely perceptible at 60 minutes following patch removal, well-defined at 24 and 48 hours, well-defined to moderate at 72 hours, absent to severe on day 7 and absent by day 14. Edema was barely perceptible at 60 minutes following patch removal, well-defined to moderate at 24 hours, barely perceptible to well-defined at 48 and 72 hours, absent to well-defined on day 7 and absent by day 14. Bodyweights were recorded pre-test and termination. There were no abnormal systemic signs noted during the observation period and body weight changes were normal.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
Supporting study
The supporting study was performed using a similar method to 16 CFR 1500.41 of the Federal Hazardous Substances Act Regulations. Six New Zealand White rabbits were clipped and then one side of the back was abraded to penetrate the stratum corneum with the other side kept intact. A 0.5 mL portion of the test material was applied to an abraded and an intact skin site of the same rabbit. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 24 hours. Treated areas were examined for erythema and edema using the Draize method of scoring at 24 and 72 hours.
Very slight to well-defined erythema and edema formation was observed at the intact and abraded sites of all animals at 24 hours. At 72 hours well-defined to moderate/severe erythema was observed at the intact and abraded sites of all animals and very slight to well-defined edema was observed at intact sites and well-defined to moderate/severe edema was observed at abraded sites of all animals. There was no evidence of reversibility over the limited timeframe of the study.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
Eye damage/irritation in vivo
The key study was performed using a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act, 0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale. No irritation was observed in any animal at any observation period.
Justification for classification or non-classification
Skin corrosion/ irritation in vivo
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the findings do not meet the criteria for classification as Category 2: Irritant; i.e. mean scores are less than the minimum classification score of 2.3 for erythema and oedema, effects are reversible within 14 days and there are no indications of variability of response amongst the test animals.
Eye damage/irritation in vivo
No ocular effects were observed in any animal at any observation period. In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
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