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EC number: 911-418-6 | CAS number: 55965-84-9
- 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
Skin irritation / corrosion
Administrative data
- 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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: 79/831/C.E.E, Annex V Section B.4
- Deviations:
- no
- GLP compliance:
- no
Test material
- Test material form:
- other: Amber Liquid
- Details on test material:
- - Name of test material (as cited in study report): Kathon™ 886
- Physical state: Amber liquid
- Stability under test conditions: stable at room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas, Batch No. not described
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Final dilution of a dissolved solid, stock liquid or gel: Undiluted
OTHER SPECIFICS: Purity of test material was 13.9%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes (Romans, 01400 Chatillon Sur Chalaronne, France)
- Age at study initiation: Adult
- Weight at study initiation: 2340 to 2500 g
Test system
- 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): 0.5 mL - Duration of treatment / exposure:
- 3 rabbits for 1 h and 3 rabbits for 4 h
- Observation period:
- 60 min after removal of gauze and then once daily for 12 days
- Number of animals:
- 6 per dose
- Details on study design:
- TEST SITE
- Area of exposure: right flank
- Type of wrap if used: The test article was covered with a gauze patch, held in place with non-irritating tape. The patch was closely held in contact with the skin by means of a suitable semi occlusive dressing for the duration of the exposure period. During this time, the animals were kept in restraining boxes.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Slightly washed with sterile water
- Time after start of exposure: 3 rabbits for 1 h and 3 rabbits for 4 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2.3
- Reversibility:
- fully reversible within: 11 days after dosing
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 2
- Reversibility:
- fully reversible within: 11 days after dosing
- Remarks on result:
- other: 1 hour expsoure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.7
- Reversibility:
- fully reversible within: 11 days after dosing
- Remarks on result:
- other: 1 hour expsoure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3
- Reversibility:
- fully reversible within: 11 days after dosing
- Remarks on result:
- other: 4 hour expsoure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 2.7
- Reversibility:
- fully reversible within: 11 days after dosing
- Remarks on result:
- other: 4 hour expsoure
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1.7
- Reversibility:
- fully reversible within: 11 days after dosing
- Remarks on result:
- other: 4 hour expsoure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2.3
- Reversibility:
- fully reversible within: Total recovery from edema was recorded after 8 days observation period
- Remarks on result:
- other: 1 hour expsoure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.3
- Reversibility:
- fully reversible within: Total recovery from edema was recorded after 8 days observation period
- Remarks on result:
- other: 1 hour expsoure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.3
- Reversibility:
- fully reversible within: Total recovery from edema was recorded after 8 days observation period
- Remarks on result:
- other: 1 hour expsoure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3.7
- Reversibility:
- fully reversible within: Total recovery from edema was recorded after 8 days observation period
- Remarks on result:
- other: 4 hour expsoure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 2
- Reversibility:
- fully reversible within: Total recovery from edema was recorded after 8 days observation period
- Remarks on result:
- other: 4 hour expsoure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.7
- Reversibility:
- fully reversible within: Total recovery from edema was recorded after 8 days observation period
- Remarks on result:
- other: 4 hour expsoure
- Irritant / corrosive response data:
- The final scoring of irritancy has been calculated with the records after one hour, 24 hours and 48 hours. The value, obtained after calculation is 5.55.
Effects were reversible. At 3 days, only three animals had a slight edema. Total recovery from edema was recorded after 8 days observation period. As for erythema, a reversal was observed after 72 hours, with a total recovery after 11 days after dosing. - Other effects:
- - Other adverse systemic effects: A small change in the body weight gain was observed on day 8 of study for the 3 animals treated for 4 hours and no incidence was recorded for the animals treated for one hour. Body weight gain was normal by day 12. No clinical signs affecting the behaviour of the animals were recorded during the conduct of the study.
Any other information on results incl. tables
Table for skin irritation study – 1 h exposure
score (average animals investigated) |
time |
Erythema |
Edema |
average score |
60 min |
2.7 |
4.0 |
24 h |
2.3 |
2.3 |
|
48 h |
2.0 |
1.3 |
|
72 h |
0.7 |
0.3 |
|
other times |
96 h (4 days) |
0.7 |
0.3 |
120 h (5 days) |
0.7 |
0.3 |
|
144 h (6 days) |
0.7 |
0.3 |
|
168 h (7 days) |
1.0 |
0.3 |
|
192 h (8 days) |
1.0 |
0.3 |
|
216 h (9 days) |
0.3 |
0.0 |
|
240 h (10 days) |
0.3 |
0.0 |
|
264 h (11 days) |
0.0 |
0.0 |
|
reversibility: * |
c |
c |
|
average time for reversibility |
after 240 h |
after 192 h |
|
*c : completely reversible; n c : not completely reversible; n : not reversible. |
Table for skin irritation study – 4 h exposure
score (average animals investigated) |
time |
Erythema |
Edema |
average score |
60 min |
3.7 |
3.7 |
24 h |
3.0 |
3.7 |
|
48 h |
2.7 |
2.0 |
|
72 h |
1.7 |
0.7 |
|
other times |
96 h (4 days) |
1.7 |
0.7 |
120 h (5 days) |
2.0 |
0.7 |
|
144 h (6 days) |
2.0 |
0.7 |
|
168 h (7 days) |
2.0 |
0.7 |
|
192 h (8 days) |
1.7 |
0.0 |
|
216 h (9 days) |
1.7 |
0.0 |
|
240 h (10 days) |
0.7 |
0.0 |
|
264 h (11 days) |
0.3 |
0.0 |
|
reversibility: * |
c |
c |
|
average time for reversibility |
after 264 h |
after 168 h |
|
*c : completely reversible; n c : not completely reversible; n : not reversible |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- A severe edema (score = 4) was observed in five animals and one animal had a moderate edema (score = 3) one hour after patch removal. This edema was raised more than 2 mm and extended beyond the area of exposure. By day 3, this irritation reversed such that only 3 animals had a slight edema. There was total recovery after 8 days.
One animal had a well-defined erythema with slight eschar formations. A reversal was observed after 72 h with total recovery after 11 days. - Executive summary:
The study was conducted in accordance with OECD Guideline 404, Acute dermal irritation/corrosion. There were no guideline deviations.
A severe edema (score = 4) was observed in five animals and one animal had a moderate edema (score = 3) one hour after patch removal. This edema was raised more than 2 mm and extended beyond the area of exposure. By day 3, this irritation reversed such that only 3 animals had a slight edema. There was total recovery after 8 days. One animal had a well-defined erythema with slight eschar formations. A reversal was observed after 72 h with total recovery after 11 days.
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