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EC number: 700-043-1 | 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
Endpoint summary
Administrative data
Description of key information
The test substance is not an skin or eye irritant.
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:
- September 8 2006 to October 23 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Kbs:JW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd
- Age at study initiation: 11 weeks
- Weight at study initiation: Average 2.20 kg
- Housing:Rabbit cage 690 x 490 x 380 (mm). Floor space 3380 cm2
- Diet: Solid feed for rabbits and guinea pigs. Approximately 120-130g of feed was fed with limit using a suspending feeder made of aluminium attached to the cage.
- Water : ad libitum, from the automatic water supply system.
- Acclimation period: 7 days after receipt.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0-22.7
- Humidity (%): 52.0-60.1
- Air changes (per hr): Over 7 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours (lighted hours: 8:00am-8:00pm
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A half mL of the test article was evenly applied to lint cloth.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours after the removal of the test article.
- Number of animals:
- 3.
- Details on study design:
- TEST SITE
Area of exposure: Approx 6 cm2 (1-inch-square, approx 2.5 cm x 2.5 cm).
Type of wrap if used: Test article applied to a lint cloth. The lint cloth was wrapped with plastic membrane and then with adhesive-elastic dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the application period, the adhesive-elastic dressing was immediately removed and the applied site of the test article was washed clean with distilled water.
- Time after start of exposure: 4 hours.
Observation of general condition
Animals were observed before the application, 1, 24, 48, and 72 hours after the
removal of the test article.
Body weight
Animals were weighed using the electronic scale before the application and 72 hours
after the removal of the test article.
Skin observation
Skin was scored based on the criteria described below for erythema and incrustation
and development of edema at 1, 24, 48, and 72 hours after the removal of the test
article. The applied site was assessed not to have any problem before the application
of the test article.
Evaluation
The test article was evaluated for corrosivity and irritability based on the average
scores for erythema and incrustation and development of edema at 24, 48, and 72
hours after the removal of the test article according to the Globally Harmonized
System of Classification and Labeling of Chemicals.
SCORING SYSTEM:
The rating criteria for skin reactions
Rating criteria Scores
1) Erythema and incrustation
No erythema ·················································································································0 points
Very mild erythema (barely visible) ·············································································1 point
Clear erythema ··············································································································2 points
Moderate to severe erythema ························································································3 points
Dark red erythema to slight incrustation (damage to deeper area) ·······························4 points
2) Development of edema
No edema ······················································································································0 points
Very mild edema (barely visible)··················································································1 point
Mild edema (clear edge recognized by obvious swelling) ············································2 points
Moderate edema (swelling to approximately 1 mm)·····················································3 points
Severe edema (swelling of 1 mm and spreading beyond the exposed area) ···············4 points - Irritation parameter:
- erythema score
- Basis:
- animal: 00101
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects seen at any time point
- Irritation parameter:
- erythema score
- Basis:
- animal: 00102
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects seen at any time point
- Irritation parameter:
- erythema score
- Basis:
- animal: 00103
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects seen at any time point
- Irritation parameter:
- edema score
- Basis:
- animal: 00101
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects seen at any time point
- Irritation parameter:
- edema score
- Basis:
- animal: 00102
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects seen at any time point
- Irritation parameter:
- edema score
- Basis:
- animal: 00103
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects seen at any time point
- Irritant / corrosive response data:
- There was no erythema and incrustation and development of edema observed in skin at 1, 24, 48, and 72 hours after the removal of the test article. Therefore, the average score for erythema and incrustation and development of edema in each animal was 0.0.
- Other effects:
- None.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Compound A was applied for 4 hours on the skin of rabbits in order to evaluate the skin irritability. No erythema and incrustation and development of edema were observed at any time at skin evaluation 1, 24, 48, and 72 hours after the removal of the test article.
As a result of skin evaluation based on the Globally Harmonized System of Classification and Labeling of Chemicals, Compound A was considered to be classified as non-corrosive and non-irritant. - Executive summary:
In a primary dermal irritation conducted to OECD Guideline 404, three rabbits were dermally exposed to 0.5ml of the undiluted test material for four hours.
After 4 hours of skin application, no erythema, incrustation, or developments of edema were observed on the skin at 1, 24, 48, and 72 hours after the removal of the test article. In addition, there was no abnormality seen in general condition or weight change. Based on the above results, Compound A was considered to be classified as non-corrosive and non-irritant.
Reference
No histopathological examination was performed since there was no skin reaction.
There was no abnormality found in general condition in animals before the application, 1, 24, 48, and 72 hours after the removal of the test article.
There was no weight loss observed in weight changes between the application and 72 hours after the removal of the test article.
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:
- The study was performed between 30 June 2009 and 10 July 2009.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd, Hillcrest, Belton, Loughborough, UK.
- Age at study initiation: Twelve to twenty weeks old.
- Weight at study initiation: 2.59 or 2.78 kg
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study
- Water (e.g. ad libitum): Free access to mains drinking water was allowed throughout the study
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature wasset to achieve limits of 17 to 23°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70% respectively.
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
The test material was used as supplied.
- Amount(s) applied (volume or weight with unit):
A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye.
VEHICLE
Not applicable. - Duration of treatment / exposure:
- 72 hours.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 2.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable.
- Time after start of exposure: Not applicable.
SCORING SYSTEM: Assessment of ocular damage/irritation was made according to the Draize Scale for Scoring Ocular Irritation.
Any other ocular effects were also noted.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- conjunctivae score
- Remarks:
- : Redness
- Basis:
- mean
- Remarks:
- : Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score of 2 at 1 hour reading.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- : Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score of 2 at 1 hour reading.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- : Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No corneal effects noted.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- : Animal 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iridial effects noted.
- Irritation parameter:
- conjunctivae score
- Remarks:
- : Redness
- Basis:
- mean
- Remarks:
- : Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score of 2 at 1 hour reading.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- : Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Max score of 2 at 1 hour reading.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- : Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No corneal effects noted.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- : Animal 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iridial effects noted.
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2.
No corneal or iridial effects were noted.
Moderate conjunctival irritation was noted in treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation.
Both treated eyes appeared normal at the 48-hour observation - Other effects:
- Individual bodyweights and bodyweight changes are given in Table 3.
All animals showed expected gain in bodyweight during the study. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)
- Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008
Result.
A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 48‑hour observation.
Conclusion.
The test material produced a maximum group mean score of 10.0and was classified as aminimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Reference
Table1 IndividualScores and Individual Total Scoresfor Ocular Irritation
Rabbit Number and Sex |
68438Male |
68441Male |
||||||
IPR= 2 |
IPR = 2 |
|||||||
Time After Treatment |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA |
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
A = Redness |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
B = Chemosis |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
C = Discharge |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
Total Score |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
IPR= Initial pain reaction
Table2 Individual Total Scores and Group Mean Scoresfor Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
68438Male |
10 |
4 |
0 |
0 |
68441Male |
10 |
4 |
0 |
0 |
Group Total |
20 |
8 |
0 |
0 |
Group Mean Score |
10.0 |
4.0 |
0.0 |
0.0 |
Table3 Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 3 |
||
68438Male |
2.78 |
2.84 |
0.06 |
68441Male |
2.59 |
2.64 |
0.05 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)
- Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Skin irritation/corrosion:
In a primary dermal irritation conducted to OECD Guideline 404, three rabbits were dermally exposed to 0.5ml of the undiluted test material for four hours.
After 4 hours of skin application, no erythema, incrustation, or developments of edema were observed on the skin at 1, 24, 48, and 72 hours after the removal of the test article. In addition, there was no abnormality seen in general condition or weight change. Based on the above results, Compound A was considered to be classified as non-corrosive and non-irritant.
Eye irritation:
Introduction.
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
Result.
A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 48‑hour observation.
Conclusion.
The test material produced a maximum group mean score of 10.0and was classified as aminimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Justification for classification or non-classification
The results of the skin and eye irritation studies do not meet the criteria for classification according to CLP (Regulation (EC) No 1272/2008) or according to DSD (Directive 67/548/EEC).
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