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EC number: 216-971-0 | CAS number: 1709-70-2
- 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
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- 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
Both studies performed to no specified methods, however written with clear and concise study plans.
Not irritating to the skin or eye.
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:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to no specified methods
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three male and 3 female New Zealand White rabbits (obtained from H.A.R.E. Rabbits far Research, Hewitt, New Jersey) were used for this study. The rabbits weighed from 2302 to 2529 grams at the beginning of the study. They were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals" and were conditioned for a minimum of 25 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum.
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- Five hundred milligrams of the test material were applied to the back of each rabbit under a one inch square gauze patch.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male
3 female - Details on study design:
- The hair was removed from the back of each rabbit (20-30% of the body surface) with an electric clipper. The skin of 3 of the rabbits was abraded with a scalpel blade. The abrasions penetrated the stratum corneum, but were not deep enough to cause bleeding.
Five hundred milligrams of the test material were applied to the back of each rabbit under a one inch square gauze patch. The application sites were then covered with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with several layers of 75 mm Elastoplast tape. A collar was also applied. Following 24 hours of application, the bandages and collars were removed and the sites were washed with tepid tap water and examined for skin irritation. The examinations were repeated at 72 hours. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 1.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Abraded skin
- Irritant / corrosive response data:
- Not specified
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Primary Irritation Score = 0.3
- Executive summary:
Primary Irritation Score = 0.3.
Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary skin irritant.
Reference
Number of Animals Exhibiting Signs with scoring Value/Number Dosed
|
Intact Skin |
Abraded Skin |
|||
Hours |
Hours |
||||
Observations |
Value |
24 |
72 |
24 |
72 |
Erythema, Eschar Formation |
0 |
1/3 |
3/3 |
2/3 |
3/3 |
1 |
2/3 |
|
1/3 |
|
|
2 |
|
|
|
|
|
3 |
|
|
|
|
|
4 |
|
|
|
|
|
Edema Formation |
0 |
3/3 |
3/3 |
3/3 |
3/3 |
1 |
|
|
|
|
|
2 |
|
|
|
|
|
3 |
|
|
|
|
|
4 |
|
|
|
|
Primary Skin Irritation – Individual Rabbit Scores and Score Calculation
Intact Skin |
||||
|
Erythema |
Edema |
||
|
Observation Period (Hours) |
Observation Period (Hours) |
||
Animal No./Sex |
24 |
72 |
24 |
72 |
33339, Male |
1.0 |
|
0 |
0 |
33367, Male |
0 |
0 |
0 |
0 |
33354, Female |
0.5 |
0 |
0 |
0 |
Total |
1.5 |
0 |
0 |
0 |
Abraded Skin |
||||
|
Erythema |
Edema |
||
|
Observation Period (Hours) |
Observation Period (Hours) |
||
Animal No./Sex |
24 |
72 |
24 |
72 |
33813, Male |
0 |
0 |
0 |
0 |
33368, Male |
0 |
0 |
0 |
0 |
33376, Female |
1.5 |
0 |
0 |
0 |
Total |
1.5 |
0 |
0 |
0 |
Calculation for Primary Skin Irritation Score (Score = The average of all the erythema scores plus the average of all the edema score): (3.0 ÷ 12) + (0.0 ÷ 12) = 0.3
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:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to no specified methods
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three male and 3 female New Zealand White rabbits (obtained from H.A.R.E. Rabbits for Research, Hewitt, New Jersey) were used for this study. The rabbits weighed from 2300 to 2813 grams at the beginning of the study. The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and "Ose of Laboratory Animals". The animals were conditioned for a period of 20 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum.
- Vehicle:
- not specified
- Controls:
- other: left eye untreated
- Amount / concentration applied:
- The rabbits received 100 milligrams of the test material
- Duration of treatment / exposure:
- Not specified
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
3 females - Details on study design:
- Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.
The rabbits received 100 milligrams of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48, 72 hours & 7 days
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Area
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Area
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48, 72 hours & 7 days
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Area
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48, 72 hours & 7 days
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- > 1 - < 2
- Max. score:
- 1.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 1 - < 2
- Max. score:
- 2.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- > 0 - < 1
- Max. score:
- 0.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 1.5
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- > 0 - < 1
- Max. score:
- 0.5
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours & 7 days
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- > 1 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Discharge
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- > 0 - < 1
- Max. score:
- 1.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: Discharge
- Irritant / corrosive response data:
- Not specified
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary eye irritant
- Executive summary:
Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary eye irritant
Reference
Primary Eye Irritation Study in the Albino Rabbit – Group Observations
|
Observations |
|
Examination Interval (No. Positive/No. Dosed) |
||||
Hours |
Day |
||||||
1 |
24 |
48 |
72 |
7 |
|||
DRAIZE SCORING VALUES |
|||||||
Cornea |
Cornea Normal |
6/6 |
3/6 |
5/6 |
6/6 |
6/6 |
|
Dulling Normal Corneal Luster |
|
2/6 |
1/6 |
|
|
||
Corneal Opacity |
Very slight |
|
1/6 |
|
|
|
|
Slight |
|
|
|
|
|
||
Moderate |
|
|
|
|
|
||
Marked |
|
|
|
|
|
||
Iris |
Iris Normal |
5/6 |
4/6 |
6/6 |
6/6 |
6/6 |
|
Iridal Irritation |
1/6 |
2/6 |
|
|
|
||
Conjunctivae |
Redness |
Normal |
|
|
2/6 |
5/6 |
6/6 |
Very slight |
|
3/6 |
2/6 |
1/6 |
|
||
Slight |
6/6 |
2/6 |
2/6 |
|
|
||
Moderate |
|
1/6 |
|
|
|
||
Marked |
|
|
|
|
|
||
Chemosis |
Normal |
1/6 |
2/6 |
5/6 |
6/6 |
6/6 |
|
Very slight |
4/6 |
4/6 |
1/6 |
|
|
||
Slight |
1/6 |
|
|
|
|
||
Moderate |
|
|
|
|
|
||
Marked |
|
|
|
|
|
||
Discharge |
Normal |
|
5/6 |
6/6 |
6/6 |
6/6 |
|
Very slight |
1/6 |
|
|
|
|
||
Slight |
4/6 |
1/6 |
|
|
|
||
Moderate |
1/6 |
|
|
|
|
||
Marked |
|
|
|
|
|
||
SODIUM FLUORESCENT/ULTRA-VIOLET LIGHT EXAMINATION |
|||||||
|
Negative (normal) |
|
--- |
--- |
--- |
6/6 |
6/6 |
Positive (corneal injury) |
--- |
--- |
--- |
0/6 |
0/6 |
||
OTHER FINDINGS |
|||||||
Clear discharge |
6/6 |
1/6 |
0/6 |
0/6 |
0/6 |
||
Blanching, conjunctivae |
3/6 |
0/6 |
0/6 |
0/6 |
0/6 |
Primary Eye Irritation Study in the Albino Rabbit – Group Average Scores
Area |
Average Scores (Range) |
|||||
Period |
||||||
Hours |
Day |
|||||
1 |
24 |
48 |
72 |
7 |
||
Cornea |
A |
0 |
0.2 (0 – 1.0) |
0 |
0 |
0 |
B |
0 |
0.5 (0 – 3.0 |
0 |
0 |
0 |
|
Score |
0 |
0.5 |
0 |
0 |
0 |
|
Iris |
A |
0.2 (0 – 1.0) |
0.3 (0 – 1.0) |
0 |
0 |
0 |
Score |
1.0 |
1.5 |
0 |
0 |
0 |
|
Conjunctivae |
A |
1.1 (1.0 – 1.5) |
1.1 (0 – 2.5) |
0.5 (0 – 1.0) |
0.1 (0 – 0.5) |
0 |
B |
1.0 (0 – 2.0) |
0.7 (0 – 1.5) |
0.1 (0 – 0.5) |
0 |
0 |
|
C |
1.3 (0.5 – 2.0) |
0.3 (0 – 1.5) |
0 |
0 |
0 |
|
Score |
6.8 |
4.2 |
1.2 |
0.2 |
0 |
|
|
Total scores |
7.8 |
6.2 |
1.2 |
0.2 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Study written with clear and concise study plan.
Justification for selection of eye irritation endpoint:
Study written with clear and concise study plan
Justification for classification or non-classification
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.