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EC number: 204-886-1 | CAS number: 128-44-9
- 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
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404. The test compound in the amount of 0.5 gm did not produce any skin reaction as well as clinical signs of toxicity throughout the observation period of 72 hours after patch removal. However, there was no corrosivity of the test compound was observed during the entire observation period of 14 days. The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under "Not Classified".
Eye Irritation:
Acute Eye Irritation/Corrosion Study of Test chemical in Rabbits, was performed as per OECD guideline No. 405. The. In the confirmatory test, the test compound when applied to the conjunctival sac of the animals produced some conjunctival blood vessels hyperemic upto 24 hours. There were no other signs observed throughout the observation period of 21 days. Based on above findings, it can be concluded that the test compound is practically non-irritant when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits and test compound can be classified under "Not Classified".
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- To evaluate the dermal irritation potential of the test chemical in New Zealand white rabbits
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- -Source : In-bred
-Age : 10 to 12 weeks
-Body weight range :1.80kg±200gm
-Identification : By cage tag and corresponding colour body marking.
-Acclimatization : The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
-Randomization : After acclimatization and Veterinary examination three females were randomly selected.
-Accommodation : Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
-Diet : Pelleted feed
-Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25 deg.C
- Humidity (%): 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours dark. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 gm of test compound
- Duration of treatment / exposure:
- 4 hrs.
- Observation period:
- 14 days
- Number of animals:
- Three female rabbits
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage:approx 6 square cm
- Type of wrap if used: impervious dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after patch removal, the site of application was cleaned with luke warm
water
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1, 24,48 and 72 hours
SCORING SYSTEM: The intact skin site of application was observed for erythema and edema and scored according to Draize method - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Skin reaction:
The test compound when applied at the dose level of 0.5 gm on shaven back skin (approximately 6 cm2) of rabbit produced Mild Erythema the site of application of test compound after four hour patch removal upto 48 hours. - Other effects:
- Clinical signs:
The test compound applied on the shaven back skin of rabbit at the dose level of 0.5 gm did not produce any clinical signs of toxicity throughout the examination period of 14 days. - Interpretation of results:
- not irritating
- Conclusions:
- The dermal irritation index of the test chemical in New Zealand white rabbits was calculated as 0.00 and test compound can be classified under "Not Classified".
- Executive summary:
A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of the test chemical.
In the initial test one healthy rabbit of body weight 1.80kg±200gm kg was selected for the study after acclimatization. The test compound in the amount of 0.5 gm was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment. The test substance in the amount of 0.5 gm was applied to a small area (approximately 6 cm2) of skin and covered with a gauze patch, which was held in place with non-irritating tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. . There were no signs of skin reaction observed at the site of application. Finally, the animal was observed for 14 days, for any irritation and corrosion.
Because no corrosive effect observed in the initial test, a confirmatory test was done in order to confirm the irritant or negative response of the test substance by using two additional animals. In the confirmatory test the test compound in the amount of 0.5 gm was applied on the shaven back skin of two animals, each with one patch, for an exposure period of four hours. After four hours the patch was removed and the skin reactions were graded according to Draize’s method.
The test compound in the amount of 0.5 gm did not produce any skin reaction as well as clinical signs of toxicity throughout the observation period of 72 hours after patch removal. However, there was no corrosivity of the test compound was observed during the entire observation period of 14 days. The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under "Not Classified".
Reference
INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES
Rabbit No. |
Sex |
INTACT SKIN |
|||||||||||
3 Min. |
4 Hours |
24 Hours |
48 Hours |
72 Hours |
14 days |
||||||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
||
01 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
F |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
03 |
F |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Grand Total |
0.00 |
Dermal Irritation Index: 0.0/4 = 0.0
CLINICAL SIGNS
SEX |
ANIMAL NO. |
Time (Min.) |
Time (Hours) |
Time (Day) |
||||
3 |
1 |
4 |
24 |
48 |
72 |
14 |
||
FEMALE
|
01 |
N |
N |
N |
N |
N |
N |
N |
02 |
N |
N |
N |
N |
N |
N |
N |
|
03 |
N |
N |
N |
N |
N |
N |
N |
N: No Clinical Signs
C: Clinical Signs Observed
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- data is from experimental reports
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To evaluate the acute eye irritation index of the test chemical in New Zealand White rabbit.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- -Source : In-bred
-Age : 10 to 12 weeks
-Body weight range :1.80kg±200gm
-Identification : By cage tag and corresponding colour body marking.
-Acclimatization : The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
-Randomization : After acclimatization and Veterinary examination three females were randomly selected.
-Accommodation : Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
-Diet : Pelleted feed
-Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25 deg.C
- Humidity (%): 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light and 12 hours dark. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, served as a control.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after test substance application
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:Scale of weighted scores for grading the severity of ocular lesions developed by //Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test compound when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produced any lesions such as pannus, staining throughout the observation period of 72 hours. However some blood vessels of conjunctiva were observed hyperemic at 1 to 24th hour after the application of test substance.
- Other effects:
- The test compound applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test compound when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produced any lesions such as pannus, staining throughout the observation period of 72 hours. However some blood vessels of conjunctiva were observed hyperemic at 1 to 24th hour after the application of test substance.The test compound Sodium saccharin applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.
Based on above findings, it can be concluded that the test compound was non-irritating when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits under test condition. - Executive summary:
The acute eye irritation study of the test chemical was conducted in New Zealand White Rabbit as per the OECD- 405 Guideline. 3 female young adult New Zealand White rabbits were used for the study.
One healthy rabbit of body weight 1.80kg±200gm was selected for study after acclimatization. Both eyes of rabbits were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound. The test compound was applied in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball at the dose rate of0.1gm.The lids were then gently held for about one second in order to prevent loss of the material. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.
The test compound when applied to conjunctival sac of rabbit in the amount of 0.1gm produces some conjunctiva blood vessels hyperemic upto 24 hours.
The result obtained from the initial test was confirmed in additional two animal of same sex and same dose level
In the confirmatory test the test compound was applied in the amount of 0.1 gm in the conjunctival sac of two more rabbits after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.
In the confirmatory test, the test compound when applied to the conjunctival sac of the animals produced some conjunctival blood vessels hyperemic upto 24 hours. There were no other signs observed throughout the observation period of 21 days.
Based on above findings, it can be concluded that the test compound is practically non-irritant when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits.
Reference
GRADING OF OCULAR LESIONS
S.NO |
SEX |
OBSERVATION |
Score |
Total score |
|||
1 |
F |
1 hour |
24hours |
48 hours |
72 hours |
||
Cornea |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
0 |
0 |
0 |
1 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
2 |
F |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
0 |
0 |
0 |
1 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
3. |
F |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
0 |
0 |
0 |
1 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
Grand total |
3 |
||||||
Total mean |
1 |
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
A dermal irritation study was conducted on New Zealand white rabbits in accordance with OECD 404 to assess the irritation parameter of the test chemical.
In the initial test one healthy rabbit of body weight 1.80kg±200gm kg was selected for the study after acclimatization. The test compound in the amount of 0.5 gm was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment. The test substance in the amount of 0.5 gm was applied to a small area (approximately 6 cm2) of skin and covered with a gauze patch, which was held in place with non-irritating tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. . There were no signs of skin reaction observed at the site of application. Finally, the animal was observed for 14 days, for any irritation and corrosion.
Because no corrosive effect observed in the initial test, a confirmatory test was done in order to confirm the irritant or negative response of the test substance by using two additional animals. In the confirmatory test the test compound in the amount of 0.5 gm was applied on the shaven back skin of two animals, each with one patch, for an exposure period of four hours. After four hours the patch was removed and the skin reactions were graded according to Draize’s method.
The test compound in the amount of 0.5 gm did not produce any skin reaction as well as clinical signs of toxicity throughout the observation period of 72 hours after patch removal. However, there was no corrosivity of the test compound was observed during the entire observation period of 14 days. The dermal irritation index of New Zealand white rabbits is calculated as 0.00 and test compound can be classified under "Not Classified".
Eye irritation
The acute eye irritation study of the test chemical was conducted in New Zealand White Rabbit as per the OECD- 405 Guideline. 3 female young adult New Zealand White rabbits were used for the study.
One healthy rabbit of body weight 1.80kg±200gm was selected for study after acclimatization. Both eyes of rabbits were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound. The test compound was applied in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball at the dose rate of0.1gm.The lids were then gently held for about one second in order to prevent loss of the material. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.
The test compound when applied to conjunctival sac of rabbit in the amount of 0.1gm produces some conjunctiva blood vessels hyperemic upto 24 hours.
The result obtained from the initial test was confirmed in additional two animal of same sex and same dose level
In the confirmatory test the test compound was applied in the amount of 0.1 gm in the conjunctival sac of two more rabbits after gently pulling the lower lid away from the eyeball. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.
In the confirmatory test, the test compound when applied to the conjunctival sac of the animals produced some conjunctival blood vessels hyperemic upto 24 hours. There were no other signs observed throughout the observation period of 21 days.
Based on above findings, it can be concluded that the test compound is practically non-irritant when applied in the amount of 0.1 gm in the conjunctival sac of the rabbits.
Justification for classification or non-classification
The skin and eye irritation potential of test chemical was observed in experimental studies. The results obtained from these studies indicate that the chemical is not likely to cause skin and eye irritation. Hence the test chemical can be classified under the category “Not Classified” for skin and eye as per CLP.
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