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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 482-110-2 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion (2004)
Under the conditions of this study, the test material is considered to be corrosive to the skin of New Zealand White Rabbits.
Eye irritation testing was not performed due to the irritant / corrosive potential of the test material established in the test for skin irritation.
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:
- 5 December 2003 to 19 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- US EPA GLPs 40 CFR, Part 792; OECD GLPs
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Male and female New Zealand White rabbits, at least 10 weeks of age, weighing 2.07 to 2.14 kg. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages. They were provided food and tap water ad libitum. Room temperature was 68 ± 5°F and the relative humidity ranged between 30-70%. Room lights were on a 12-hour light/dark cycle.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Approximately 24 hours prior to dosing, the application sites were prepared by clipping the skin of the trunk free of hair (not less than 10% of the body surface was clear for the application of the test substance). One half gram (0.5 mL) of the test substance was applied to a small area of the skin (approximately 6 cm²).
- Duration of treatment / exposure:
- Each application area was covered with a gauze patch and secured with non-irritating tape.
Initially, three test patches were applied sequentially to a single animal and removed after three minutes, one hour and then four hours of contact to assess for possible corrosion. Once it was determined that a four-hour exposure could humanely be allowed, a single test patch was applied to two additional animals for a four hour exposure period. - Observation period:
- Dermal scores were recorded at 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs. Animals were weighed at Day 0 prior to dose administration and at the end of the observation period (Day 14).
- Number of animals:
- 3
- Details on study design:
- Erythema and Edema formation were observed/scored based upon the following definitions: see tables below
- Irritation parameter:
- erythema score
- Basis:
- animal: 31649
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 31650
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 31651
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal: 31649
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 31650
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal: 31651
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- In the initial test, no signs of erythema or edema were present after 3 minutes. After one hour, well-defined erythema and edema was observed. Although a skin reaction was noted, the observation indicated that the exposure could humanely extend to four hours. One hour after the four hour exposure, similar scores of well-defined erythema and edema were recorded.
The additional two rabbits tested were observed to have well-defined erythema and edema at one hour after patch removal. All three rabbits showed signs of erythema and edema varying from slight to moderate at the 24 hour observation period. All rabbits continued to show well-defined to moderate erythema with signs of edema varying from slight to moderate at the 48 and 72 hour observation points.
All rabbits were scored daily up to day 14 to observe the nature and reversibility of the responses. By day four, eschar formation was observed in two rabbits and was observed on the following day in the third rabbit. During the 14 day period, a sloughing of the eschar at the dosing site occurred and the surrounding skin was noted to be dry and flaky. Signs of the erythema decreased with no signs of edema after one week. By day 11, eschar formation had resolved in two rabbits but by day 14 the presence of scar rissue and alopecia was still noted at the dosing site in one rabbit.
None of the control sites of any animal at any of the observation periods showed signs of erythema or edema. - Other effects:
- All animals gained weight over the course of the study. No overt signs of toxicity were evident in any of the animals during the course of the study.
- Interpretation of results:
- other: EU Criteria: Category 1B: Causes sever skin burns and eye damage (H314)
- Conclusions:
- Under the conditions of this study, the test material is considered to be corrosive to the skin of New Zealand White Rabbits.
- Executive summary:
The test material was evaluated for its potential to produce primary dermal irritation or corrosion after a single topical 4 hour application to the skin of New Zealand White rabbits, according to the standardised guidelines OECD 404 (2002) and US EPA OPPTS 870.2500 (1998), under GLP conditions.
All rabbits were observed to have slight to moderate erythema and edema through the 72 hour period with eschar formation occuring by day four. Irritation and eschar formation resolved by day 11 in two rabbits but by day 14 the presence of scar tissue and alopecia was still noted in one rabbit.
Under the conditions of this study, the test material is considered to be corrosive to the skin of New Zealand White Rabbits.
Reference
Skin Irritation Scores for the Test Sites
Observation Period* |
Ob |
Animal Number |
||
31649 |
31650 |
31651 |
||
1 h |
ER |
2£ |
2 |
2 |
ED |
1 |
2 |
2 |
|
24 h |
ER |
2£ |
2 |
2 |
ED |
3 |
1 |
2 |
|
48 h |
ER |
2 |
2 |
2 |
ED |
3 |
1 |
2 |
|
72 h |
ER |
2 |
3 |
2 |
ED |
2 |
1 |
2 |
|
Day 4 |
ER |
4^ |
4^ |
3 |
ED |
2 |
2 |
2 |
|
Day 5 |
ER |
4^$ |
3^$ |
4^ |
ED |
2+ |
1 |
2 |
|
Day 6 |
ER |
3^$ |
3^$ |
3^$ |
ED |
1+ |
0 |
1@ |
|
Day 7 |
ER |
3^$ |
1+ |
1^$ |
ED |
0+ |
0 |
0+ |
|
Day 8 |
ER |
2^ |
1+ |
1^$ |
ED |
0+ |
0 |
0+ |
|
Day 9 |
ER |
2& |
1@ |
1@ |
ED |
0 |
0 |
0 |
|
Day 10 |
ER |
1& |
1@ |
0 |
ED |
0 |
0 |
0 |
|
Day 11 |
ER |
1& |
0 |
0 |
ED |
0 |
0 |
0 |
|
Day 12 |
ER |
1& |
0 |
0 |
ED |
0 |
0 |
0 |
|
Day 13 |
ER |
1& |
0 |
0 |
ED |
1 |
0 |
0 |
|
Day 14 |
ER |
0& |
0 |
0 |
ED |
0 |
0 |
0 |
|
* After patch removal. £ Yellow discoloration ^ Eschar formation + Discoloration and alopecia $ Skin is dry and flaky & Scar tissue, alopecia @ Hard scaly skin |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
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:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vivo skin irritation/corrosion (2004)
The test material was evaluated for its potential to produce primary dermal irritation or corrosion after a single topical 4 hour application to the skin of New Zealand White rabbits, according to the standardised guidelines OECD 404 (2002) and US EPA OPPTS 870.2500 (1998), under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
All rabbits were observed to have slight to moderate erythema and edema through the 72 hour period with eschar formation occuring by day four. Irritation and eschar formation resolved by day 11 in two rabbits but by day 14 the presence of scar tissue and alopecia was still noted in one rabbit.
Under the conditions of this study, the test material is considered to be corrosive to the skin of New Zealand White Rabbits.
Eye irritation
In accordance with column 2 of REACH Annex VII, information requirement 8.2, a study does not need to be conducted if the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1). Findings from the in vivo skin irritation study indicate that the substance should be classified for skin corrosion and as such, an eye irritation study is not considered to be required.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance is classified as Category 1B: Causes sever skin burns and eye damage (H314). The classification for eye is based on the results of the skin irritation study, through a weight-of-evidence approach.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)