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EC number: 240-362-9 | CAS number: 16251-77-7
- 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 (rabbit): non irritating
Eye irritation (rabbit): non 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:
- November 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study performed accordingly to accepted guidelines. Test report is not fully documented.
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Deviations:
- yes
- Remarks:
- Observation at 48-hr was not recorded
- Principles of method if other than guideline:
- Guidelines (as stated on the report):
(1) Draize et al in “Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics”, Assoc. of Food and Drug Officials of the U.S., (1965) P-C. Box 1494, Topeka, Kansas;
(2) Marzulli, F.N. and Ruggles, D.l., Jour AOAC 56 (1973);
(3) Federal Hazardous Substances Act, CFR Title 16, Chap. 11, Parts 1500.3, 1500.40, 1500.41, 1500.42. - GLP compliance:
- no
- Remarks:
- pre-dates GLP
- Species:
- rabbit
- Strain:
- other: Albino rabbits
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- No data available. Duration of treatment / exposure is expected to be 4 hrs as described in the guidelines.
- Observation period:
- 72 hours
- Number of animals:
- 6 rabbits
- Details on study design:
- 0.5 ml under gauze dressing to the clipped intact ("int.") and abraded ("abr.") skin of adult albino rabbits with observations for erythema and edema at 24 and 72 hours.
- Irritation parameter:
- other: primary irritation score
- Basis:
- mean
- Time point:
- other: 24 - 72 hrs
- Score:
- 1.8
- Max. score:
- 2.5
- Reversibility:
- no data
- Remarks on result:
- other: details are reported below
- Irritant / corrosive response data:
- The tested material produced a primary skin irritation score of 1.8, including consideration of data for intact and abraded skin. The tested material is slightly irritating, however it is not classified for this endpoint, as stated in the report, according to guidelines of the Consumer Product Safety Commission..
As described in the report, a score of "5" or more is considered indicative of a primary irritant. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- Conclusions:
- Based on the overall irritation score for both intact and abraded skin being 1.8, the substance would not be considered a skin irritant under CLP.
- Executive summary:
A skin irritation study in rabbits was conducted to determine the potential of the substance to act as a skin irritant. The substance was applied undiluted under gauze dressing to clipped intact as well as abraded skin, and skin responses were evaluated at 24 and 72 hours. While the scoring system was not provided in the available report, and both intact and abraded testing was conducted, it was noted that the maximum score for any animal at any time point was 2 (a score of 5 would have been considered an indication of a primary irritant). Additionally, the intact and abraded sites showed similar scores. The overall primary irritation score was 1.8. As such, the substance is not considered a skin irritant.
Reference
Results for erythema and eschar scoring, and edema scoring, are provided below.
Animal# |
Erythema & Eschar |
Edema |
Individual primary irritation score |
||||||
24 |
72 |
24 |
72 |
||||||
Int. |
Abr. |
Int. |
Abr. |
Int. |
Abr. |
Int. |
Abr. |
||
1 |
1 |
1 |
2 |
2 |
1 |
1 |
0 |
1 |
2.25 |
2 |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
2.0 |
3 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1.0 |
4 |
1 |
1 |
1 |
1 |
0 |
0 |
2 |
2 |
2.0 |
5 |
2 |
2 |
2 |
2 |
0 |
0 |
1 |
1 |
2.5 |
6 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
1.0 |
Int. = intact skin; Abr = abraded skin.
Individual primary irritation scores were a sum of all scores for an animal divided by 4. Both intact and abraded skin scores were included in the calculation of the overall primary irritation score of 1.8 considering the average value of the individual primary irritation scores.
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:
- November 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study performed accordingly to accepted guidelines. Test report is not fully documented.
- Qualifier:
- according to guideline
- Guideline:
- other: see below
- Deviations:
- not specified
- Principles of method if other than guideline:
- Guidelines (as stated on the report):
(1) Draize et al in “Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics”, Assoc. of Food and Drug Officials of the U.S., (1965) P-C. Box 1494, Topeka, Kansas;
(2) Marzulli, F.N. and Ruggles, D.l., Jour AOAC 56 (1973);
(3) Federal Hazardous Substances Act, CFR Title 16, Chap. 11, Parts 1500.3, 1500.40, 1500.41, 1500.42. - GLP compliance:
- no
- Remarks:
- pre-dates GLP
- Species:
- rabbit
- Strain:
- other: albino rabbit
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Not applicable. The test material was not rinsed away after application in the eye.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- The test material was administered as 0.1 mL by volume into the eye of an albino rabbit without rinsing followed by gross observations daily under white light and under longwave ultra violet light subsequent to fluorescein staining. Corneal opacity was observed for 14 days.
- Irritation parameter:
- other: Cornea, Iris, Fluorescein, Redness, Chemosis, Discharge
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: details are reported below
- Irritant / corrosive response data:
- The tested material was not an eye irritant when tested in rabbits by the method of Draize, as stated in the report. Transient damage to the corneal epithelium however, was observed in 3/6 rabbits as judged by fluorescein staining.
The tested material is considered to be slightly irritating, however it is not classified for this endpoint under CLP. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
- Conclusions:
- There were no positive scores indicating irritation to the eye. Slight redness, chemosis, and discharge were observed in some animals on some days of the study, but all animals were normal on Day 4. Overall, the data indicate that the substance is not irritating to the eye.
- Executive summary:
An eye irritation study in rabbits was conducted to evaluate the potential of the substance to cause irritation to the eye. Following instillation of 0.1 mL of the undiluted substance into the eye, the only effects observed were slight redness, chemosis, and discharge in a few animals on some days of the study, with all animals showing scores of "0" by Day 4. There were no positive scores for these parameters, nor for readings of the cornea or iris. Fluorescein staining indicated transient damage to the corneal epithelium. Based on these results, the substance is considered not to be an irritant to the eye.
Reference
Rabbit# |
Reading at Day |
|||||||
0 |
1 |
2 |
3 |
4 |
7 |
14 |
||
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Fluorescein |
N |
N |
N |
N |
N |
|
|
|
Redness |
0 |
1 |
1 |
0 |
0 |
|
|
|
Chemosis |
0 |
1 |
0 |
0 |
0 |
|
|
|
Discharge |
0 |
1 |
0 |
0 |
0 |
|
|
|
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Fluorescein |
N |
+ |
+ |
N |
N |
|
|
|
Redness |
0 |
0 |
1 |
0 |
0 |
|
|
|
Chemosis |
0 |
1 |
1 |
0 |
0 |
|
|
|
Discharge |
0 |
1 |
1 |
1 |
0 |
|
|
|
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Fluorescein |
N |
N |
N |
N |
N |
|
|
|
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
|
|
Discharge |
0 |
0 |
0 |
0 |
0 |
|
|
|
4 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Fluorescein |
N |
+ |
N |
N |
N |
|
|
|
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
|
Chemosis |
0 |
1 |
0 |
0 |
0 |
|
|
|
Discharge |
0 |
1 |
1 |
1 |
0 |
|
|
|
5 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Fluorescein |
N |
N |
N |
N |
N |
|
|
|
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
|
Chemosis |
0 |
1 |
1 |
0 |
0 |
|
|
|
Discharge |
0 |
1 |
1 |
1 |
0 |
|
|
|
6 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Fluorescein |
N |
+ |
N |
N |
N |
|
|
|
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
|
Chemosis |
0 |
1 |
0 |
0 |
0 |
|
|
|
Discharge |
0 |
1 |
0 |
0 |
0 |
|
|
Cornea & Iris - score of 1 or above is positive
Redness & Chemosis - score of 2 or above is positive
N = Negative
+ = Positive Fluorescein staining
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of the substance was evaluated in albino rabbits in a pre-GLP study (Gibraltar Laboratories, 1981a, dated November 20, 1981). Based on an overall primary irritation score of 1.8 in intact and/or abraded skin, it was concluded that the test material is not an irritant to skin.
The eye irritation potential of the substance was evaluated in albino rabbits in a pre-GLP study (Gibraltar Laboratories, 1981b, dated November 16, 1981). Although slight redness, chemosis, and discharge were observed in some animals of some days, it was concluded that the test material is not an irritant to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Klimisch 2 study similar to guideline study
Justification for selection of eye irritation endpoint:
Klimisch 2 study similar to guideline study
Justification for classification or non-classification
Skin corrosion / irritation: the substance is non-corrosive and non-irritating in an in vivo skin irritation study. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.2.
Serious Eye Damage / Eye Irritation: the substance is non-corrosive and non-irritating in an in vivo eye irritation study. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.3.
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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