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EC number: 210-568-3 | CAS number: 618-88-2
- 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:
No clinical signs of Erythema and Edema were observed during the observation period, thus indicating that the test chemical is not irritating to skin of rabbits.
Eye irriration:
The test substance was observed to be irritating to the Eye when eye irritation study was conducted on rabbits.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data is from study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Assesment of a possible irritating or corrosive potential of the skin
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Male: 2.79 gm
Female: 2.85 gm
- Housing: Cage made of stainless steel with wire mesh walk floors. (Floor area: 40cm x 51cm)
- Diet (e.g. ad libitum):
- Water : 250 ml tap water/animal/day
- Acclimation period: Atleast 8 days before the study. Same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): Fully air conditioned
- Photoperiod (hrs dark / hrs light): 12h/12h (6.00-18.00 hours/18.00-6.00 hours)
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 50% aqueous formulation (W/W)
THE TEST PATCH (2.5 CM X 2.5 CM) IS COVEREO WITH AN ABOUT 0.5 MM LAYER OF THE 50% SUSPENSION (THUS ABOUT 0.5 G OF THE SUSPENSION IS APPLIED; BECAUSE OF THE NATURAL MOISTURE OF TNE SKIN, DISTILLED WATER IS USED TO PREPARE THE SUSPENSIONS SO THAT THE TEST CAN BE CARRIED OUT UNDER AS PHYSIOLOGICAL CONDITIONS AS POSSIBLE. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes after the removal of the test patch.
24, 48 and 72 hours after the beginning of the application - Number of animals:
- Total: 3
Male: 1
Female: 2 - Details on study design:
- TEST SITE
- Area of exposure: Upper third of the back or flanks
- % coverage: (2.5cm x 2.5 cm)
- Type of wrap if used: Porous dressing (Four layers of absorbent gauze+porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, at the end of the exposure period with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 72 hrs
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 30-60 minutes after removal of the test patches and 24, 48 and 72 hours after the beginning of the application.
SCORING SYSTEM:
- Method of calculation: - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation potential observed
- Other effects:
- No other effects observed.
- Interpretation of results:
- other: Not irritating
- Conclusions:
- No clinical signs of Erythema and Edema were observed during the observation period, thus indicating that the test chemical is not irritating to skin of rabbits.
- Executive summary:
Acute skin irritation test, according to OECD guidelines 404 for testing of chemicals, was conducted on the intact dorsal skin of the Vienna white rabbit for test substance. 50% aqueous solution of the test substance was applied in an area of 2.5 cm x 2.5cm on the upper third of the back of the test animals. The test animals were exposed for 4 hours and readings were taken 30 -60 minutes after the removal of test patches and 24 H, 48 H. 72 H, after the beginning of application. Untreated skin sites of the same animal were treated as negative control. Observations were made for appearance of any symptoms of Erythema and Edema on the tested skin sites. However, none of the observations taken at different intervals showed any clinical signs of Erythema and Edema. Based on the results, the test substance was considered as not irritating to skin.
Reference
Table: Body weight data
Animal |
1 |
2 |
3 |
Animal no. |
0075 |
0100 |
0085 |
Body weight (kg) |
2.79 |
2.72 |
2.97 |
Sex |
Male |
Female |
Female |
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Data is from study report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Assesment of a possible irritating potential to the eye and to the eye mucosa
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:
Male: 2.66 kg
Female: 2.45 kg
- Housing: Cage made of stainless steel with wire mesh walk floors. Floor area: 40cm x 51 cm
- Diet (e.g. ad libitum): KLIBA 341. 4 MM; FIRMA KLINGENTALMUEHLE AG CH-4303 KAISERAUGST. SWITZERLAND (ABOUT 130 G PER ANIMAL PER DAY)
- Water : About 250ml tap water per animal per cage
- Acclimation period: Atleast 8 days before the beginning of the study: Same housing conditions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): Fully air conditioned
- Photoperiod (hrs dark / hrs light): 12h/12h (6.00-18.00 hours/18.00-6.00 hours) - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml bulk volume ( About 43 mg of the comminuted test substance)
- Duration of treatment / exposure:
- 1Hr; 24Hrs; 48Hrs; 72Hrs; 8D after application.
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1 male
2 females - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- > 3 - < 3.7
- Max. score:
- 3.2
- Reversibility:
- not specified
- Remarks on result:
- other: Severe eye irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0 - <= 0.3
- Max. score:
- 0.1
- Reversibility:
- not specified
- Remarks on result:
- other: Normal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 1.3 - <= 2
- Max. score:
- 1.7
- Reversibility:
- not specified
- Remarks on result:
- other: Well defined
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance was observed to be irritating to the Eye when eye irritation study was conducted on rabbits.
- Executive summary:
Study, according to OECD guideline 405, was conducted on rabbit (strain Vienna White) to observe the eye irritation potential of test substance. 0.1 ml bulk volume (about 43 mg of comminuted test substance) was applied to the conjunctival sac of the right eyelid of the test animals. One male and two female animals were tested. Readings were taken at 1H, 24H, 48H, 72H, 8 Day after the application.Clinical symptoms were observed within one hour of the application and at the end of observations period (8 days), symptoms like loss of corneal tissue, loss of hair at the margins of eyelid, marginal vascularization of the cornea, small retractions in the eyelid were observed. Based on the symptoms, the following scores for ocular lesions were assigned: cornea score -3.2, iris score -0.1 and conjunctivae score 1.7. Accordingly the substance is classified as irritating to eyes. .
Reference
Table 1: Body weight data
Animal |
1 |
2 |
3 |
Animal no. |
0201 |
0186 |
0161 |
Body weight (kg) |
2.50 |
2.40 |
2.66 |
Sex |
Female |
Female |
Male |
Table 2: Scores of eye irritation study
Readings |
Animal |
Cornea OP |
Iris |
Conjunctiva |
Symptoms |
|
Red |
SW |
|||||
1 hour |
1 |
2 |
0 |
2 |
2 |
Pupil contracted |
|
2 |
3 |
0 |
2 |
2 |
Pupil contracted |
|
3 |
2 |
0 |
2 |
2 |
|
24 hour |
1 |
3 |
0 |
2 |
2 |
S3 |
|
2 |
3 |
0 |
2 |
2 |
S/RE/S3 |
|
3 |
3 |
0 |
2 |
2 |
S3/S |
48 hour |
1 |
3 |
0 |
2 |
1 |
S3/S |
|
2 |
3 |
0 |
2 |
2 |
S/RE/S3 |
|
3 |
4 |
0 |
2 |
2 |
S3/S |
72 hour |
1 |
3 |
1 |
2 |
1 |
S3/S |
|
2 |
3 |
0 |
2 |
1 |
S/RE/S3 |
|
3 |
4 |
0 |
2 |
2 |
S3/S |
8 day |
1 |
3 |
1 |
2 |
0 |
S/RE/S3/PC/S4 |
|
2 |
4 |
0 |
2 |
1 |
S/RE/S3/LH/S4 |
|
3 |
4 |
1 |
2 |
2 |
S3/S/MV/S4 |
Mean |
1 |
3.0 |
0.3 |
2.0 |
1.3 |
|
|
2 |
3.0 |
0.0 |
2.0 |
1.7 |
|
|
3 |
3.7 |
0.0 |
2.0 |
2.0 |
|
Mean |
|
3.2 |
0.1 |
2.0 |
1.7 |
|
Explanation of symptoms:
S3: Loss of corneal tissue
S4: Study disconnected after 8 day because of severe opacity
LH: Loss of hair at margins of eyelids
MV: Marginal vascularization of the cornea
PC: Pupil contraction
RE: Small retraction in the eyelids
S: Suppuration
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation:
Acute skin irritation test, according to OECD guidelines 404 for testing of chemicals, was conducted on the intact dorsal skin of the Vienna white rabbit for test substance. 50% aqueous solution of the test substance was applied in an area of 2.5 cm x 2.5cm on the upper third of the back of the test animals. The test animals were exposed for 4 hours and readings were taken 30 -60 minutes after the removal of test patches and 24 H, 48 H. 72 H, after the beginning of application. Untreated skin sites of the same animal were treated as negative control. Observations were made for appearance of any symptoms of Erythema and Edema on the tested skin sites. However, none of the observations taken at different intervals showed any clinical signs of Erythema and Edema. Based on the results, the test substance was considered as not irritating to skin.
Eye Irritation:
Study, according to OECD guideline 405, was conducted on rabbit (strain Vienna White) to observe the eye irritation potential of test substance. 0.1 ml bulk volume (about 43 mg of comminuted test substance) was applied to the conjunctival sac of the right eyelid of the test animals. One male and two female animals were tested. Readings were taken at 1H, 24H, 48H, 72H, 8 Day after the application.Clinical symptoms were observed within one hour of the application and at the end of observations period (8 days), symptoms like loss of corneal tissue, loss of hair at the margins of eyelid, marginal vascularization of the cornea, small retractions in the eyelid were observed. Based on the symptoms, the following scores for ocular lesions were assigned: cornea score -3.2, iris score -0.1 and conjunctivae score 1.7. Accordingly the substance is classified as irritating to eyes.
Justification for classification or non-classification
Based on the above studies on test chemical, it can be concluded that the test chemical was not irritating to skin but was irritating to eyes. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for skin irritation and classified at 'Category 2' for Eye irritation.
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