Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 279-815-0 | CAS number: 81782-77-6
- 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
Key study skin irritation: Arcelin (2000), OECD 404 and EU Method B.4: Not irritating.
Key study eye irritation: Anonymous (1980) an adaptation of the Draize (1955) method equivalent to OECD 405 and EU Method B.5: Not irritating (Rabbit)
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:
- 8th August 2000 to 5th September 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France- Age at study initiation: 14 weeks (males) and 15 weeks (females)- Weight at study initiation: 2.7 - 2.9 kg- Housing: Individually in stainless steel cages- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum, batch no. 30/00, provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Haysticks, QS n. 137/00, provided by Eberle Nafag AG, CH-9200 Gossau- Water (e.g. ad libitum): Tap water from Füllinsdorf, ad libitum- Acclimation period: 6 days under laboratory conditionsENVIRONMENTAL CONDITIONS- Temperature (°C): 21 - 23.5 °C- Humidity (%): 44 - 79 %- Air changes (per hr): 10 - 15 charges per hour- Photoperiod (hrs dark / hrs light): 12 hrs light and 12 hours dark.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): Single dose of 0.5 mL
- Duration of treatment / exposure:
- Duration of exposure: 4 hours
- Observation period:
- A total of 21 days at the following time points: 1, 24, 48 and 72 hours and 7, 10, 14, 17 and 21 days.
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE- Area of exposure: 6 cm² (2.5 x 2.5 cm)- Type of wrap if used: Approximately 6 cm² of surgical gauze, covered with a semi-occlusive dressing, which was wrapped around the abdomen and anchored with tape.REMOVAL OF TEST SUBSTANCE- Washing (if done): Yes with lukewarm tap water.- Time after start of exposure: 4 hours post application.OBSERVATIONS:Mortality/Viability - Daily until termination of the test.Clinical Signs - Daily until termination of the test.Body weight - At the start of acclimatisation, day of application and at termination of the test.No necropsy was performed.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Irritation scores were calculated as a mean of the three animals over the three time point 24, 48 and 72 hours for both erythema and oedema.Slight scaling was observed in all animals at day 7 all were recoved by day 21
- Other effects:
- Mortality - none occurred.Clinical Signs - no systemic signs of toxicity.Body Weight - all rabbits were considered to be within the normal range of variability.Colouration - no staining to the skin was observed.Corrosion - no irreversible alterations of the treated skin were observed nor were corrosion effects evident on the skin.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material was determined to be not irritating. Slight erythema (1.33) and oedema (0.56) were observed, however the effects were not severe enough to trigger a classification and all effects were fully reversible within 21 days.
- Executive summary:
In a GLP compliant skin irritation study, performed to standardised guidelines OECD 404 and EU method B.4 the irritation potential of the test material was determined in a 4 hour semi-occlusive test. Three rabbits were exposed to 0.5 mL of the unchanged test material for a duration of 4 hours and observed for 21 days. The mean scores from observation at 24, 48 and 72 hours were used to determine a classification. Slight erythema 1.33 and oedema 0.56 were observed, however, the effects were not severe and were fully reverse within 21 days. Under the conditions of the test, the test material was determined to be not irritating, and no classification is required under Regulation 1272/2008.
Reference
Table 2. Individual Skin Irritation Scores.
Animal |
Sex |
Evaluation Interval |
Erythema |
Oedema |
Cumulative |
Scaling |
|
Score |
Mean |
||||||
73 |
M |
1 hour |
2 |
2 |
4 |
3.33 |
0 |
74 |
F |
2 |
1 |
3 |
0 |
||
75 |
F |
2 |
1 |
3 |
0 |
||
73 |
M |
24 hours |
2 |
1 |
3 |
3.00 |
0 |
74 |
F |
2 |
1 |
3 |
0 |
||
75 |
F |
2 |
1 |
3 |
0 |
||
73 |
M |
48 hours |
1 |
1 |
2 |
2.00 |
0 |
74 |
F |
2 |
1 |
3 |
0 |
||
75 |
F |
1 |
0 |
1 |
1 |
||
73 |
M |
72 hours |
1 |
0 |
1 |
0.67 |
0 |
74 |
F |
1 |
0 |
1 |
0 |
||
75 |
F |
0 |
0 |
0 |
1 |
||
73 |
M |
7 days |
0 |
0 |
0 |
0.00 |
2 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
1 |
||
73 |
M |
10 days |
0 |
0 |
0 |
0.00 |
1 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
0 |
||
73 |
M |
14 days |
0 |
0 |
0 |
0.00 |
0 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
0 |
||
73 |
M |
17 days |
0 |
0 |
0 |
0.00 |
0 |
74 |
F |
0 |
0 |
0 |
1 |
||
75 |
F |
0 |
0 |
0 |
0 |
||
73 |
M |
21 days |
0 |
0 |
0 |
0.00 |
0 |
74 |
F |
0 |
0 |
0 |
0 |
||
75 |
F |
0 |
0 |
0 |
0 |
Table 3. Mean Skin Irritation Scores After 48 and 72 Hours.
Animal |
Sex |
Erythema |
Oedema |
73 |
M |
1.33 |
0.67 |
74 |
F |
1.67 |
0.67 |
75 |
F |
1.00 |
0.33 |
Mean |
|
1.33 |
0.56 |
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:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 3 concentrations were used to determine the minimal irritating and the maximal non-irritating dose. The top dose employed was 100 %
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 3 concentrations were used to determine the minimal irritating and the maximal non-irritating dose. The top dose employed was 100 %
- Principles of method if other than guideline:
- Adaptation of the Draize (1955) method.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: no data
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Diethyl Phthalate or unchanged
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL:- Amount(s) applied (volume or weight with unit): 0.1mL of the test material applied to one eye (the untreated eye served as the control)- Concentration (if solution): 100, 30 and 10 %.- Dilutions were made in Diethyl Phthalate.
- Observation period (in vivo):
- The observation period was 14 days at the following time points: 0, 1, 24, 48, 72 hours and day 7 and 14.
- Number of animals or in vitro replicates:
- 3 rabbits per concentration.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: NoSCORING SYSTEM:- Draize scale (1977).
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100 % concentration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100 % concentration
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.34
- Max. score:
- 7
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100 % concentration
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100 % concentration
- Irritant / corrosive response data:
- Scores were calculated as means of three animals as an average of 24, 48 and 72 hours.
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The test material was determined to be unclassified for eye irritation. Application of the undiluted test material caused moderate conjunctival irritation and corneal opacity which only lasted 3 days, however these effects are not severe enough to require classification under Regulation 1272/2008.
- Executive summary:
In a non GLP compliant study the eye irritation of the test material was determined according to an adapted Draize method. Three rabbits were exposed to the neat test material and dilutions of 10 and 30 %. The effects were observed over 14 days and scored according to the Draize scale. In the case of the undiluted application, conjunctival redness, slight chemosis and corneal opacity were observed, however these effects only lasted 3 days. The effects seen as a result of exposure to the test material are not severe enough to require classification under Regulation 1272/2008.
Reference
Table 2. Irritation Reading From Application of Test Material at 100 %
1 hour |
24 hours |
48 hours |
72 hous |
7 days |
14 days |
|||||||||||||||
Animal No. |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
||
Observation |
Concentration |
|||||||||||||||||||
CORNEA |
Opacity |
100% |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Ulceration |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Stain retention |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
IRIS |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
CONJUNCTIVA |
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Ulceration |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
DISCHARGE |
|
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key study Arcelin (2000) was submitted to fulfil the data requirements of this endpoint. The study was performed to GLP and in line with the standardised guidelines OECD 404 and EU Method B.4. The study was performed to a good standard and was assigned a reliability score of 1, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-irritating.
Justification for selection of eye irritation endpoint:
The key study Anonymous (1980) was submitted to fulfil the data requirements of this endpoint. The study was performed according to an adaption of the Draize (1955) method which was equivalent to current guideline OECD 405 and EU Method B.5. The study was performed to a good standard and was assigned a reliability score of 2, in accordance with Klimisch (1997). Under the conditions of the test, the test material was determined to be non-irritating.
Justification for classification or non-classification
According to the criteria outlined in Regulation 1272/2008 and Directive 67/548/EEC, the test material does not meet the criteria for classification for skin or eye irritation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.