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EC number: 236-291-8 | CAS number: 13282-70-7
- 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
Two valid studies are available for the test item NDPSa (Cas n.: 13282-70-7,other identifier: H-31339).
GHS Cat. 1; primary eye irritation test on rabbits; OECD TG 405; D. Merrill (2014)
Not-classified; primary skin irritation in rabbits; OECD TG 404; D. Merrill (2014)
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:
- From : 2014-10-28 To: 2014-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc. Mocksville, NC on November 5 and November 12, 2014.
- Age at study initiation: Young adult (10 weeks)
- Weight at study initiation: 2383-2702 grams at experimental start.
- Housing:stainless steel caging.
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet® #2031. A designated amount of the diet was available to each rabbit (approximately 150 grams/day).
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum.
- Acclimation period:6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-50%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle.
IN-LIFE DATES: From: To: - Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Five-tenths of a gram of the test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 30-60 minutes and 24, 48 and 72 hours.- Irritation parameter:
- erythema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no skin irritation observed at any treated site during this study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required.
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required. - Executive summary:
A primary skin irritation test was conducted with rabbits to determine the potential for H-31339 to produce irritation after a single topical application.
At the request of the Sponsor, the study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al.1 (see Table 4) immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.
There was no skin irritation observed at any treated site during this study.
In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required based on the results of this study.
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required.
Reference
Individual Skin Irritation Scores
Erythema/Edema
|
|
| Time After Patch Removal | |||
Animal n. | Sex | Immediately after patch removal | 30-60 min | 24 hrs | 48 hrs | 72 hrs |
3501 | F | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 |
3502 | F | n/a | 0/0 | 0/0 | 0/0 | 0/0 |
3503 | F | n/a | 0/0 | 0/0 | 0/0 | 0/0 |
N/A – Not Applicable
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:
- From: 2014-10-28 To: 2014-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The protocol states that all animals will be examined using ophthalmic fluorescein sodium and scored at the 24-hour interval. Due to the severity of opacity and other irritation observed with a white light source, fluorescein was not applied to the eye.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc. Mocksville, NC on November 12, 2014.
- Age at study initiation: Young adult (10 weeks)
- Weight at study initiation: 2235 grams
- Housing: stainless steel caging
- Diet (e.g. ad libitum): Harlan Teklad Global High Fiber Rabbit Diet® 2031. A designated amount of the diet (approximately 150 grams/day) and a Premium Timothy CubeTM (Ontario Dehy Inc.) were available to the rabbit.
- Water (e.g. ad libitum): Filtered tap water was supplied ad libitum.
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 41-42
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
IN-LIFE DATES: From: 17 November 2014 To: 18 November 2014 - Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution):One-tenth of a milliliter - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- 1 animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): n/a
- Time after start of exposure: 1 hour
TOOL USED TO ASSESS SCORE: white lamp and fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: Red Discharge
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Study terminated
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Study terminated
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis and Discharge
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Study terminated
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Study terminated
- Irritant / corrosive response data:
- Within one hour following test substance instillation, the treated eye of the animal exhibited conjunctival redness (score of 1), chemosis (score of 3), and discharge (score of 3). By 24 hours, iritis and corneal opacity also developed.
- Other effects:
- Due to the severity of irritation in the treated eye, the animal was euthanized for humane reasons.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classified as Corrosive.
According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013, H-31339 is classified in Category 1. - Executive summary:
A primary eye irritation test was conducted with rabbits to determine the potential for H-31339 to produce irritation from a single instillation via the ocular route.
At the request of the Sponsor, the study was conducted in a stepwise fashion. One-tenth of a milliliter of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.1 (see Table 4). Due to the severity of irritation noted in the treated eye, the animal was euthanized for humane reasons and the study was terminated.
Within one hour following test substance instillation, the treated eye of the animal exhibited conjunctival redness (score of 1), chemosis (score of 3), and discharge (score of 3). By 24 hours, iritis and corneal opacity also developed. Due to the severity of irritation in the treated eye, the animal was euthanized for humane reasons.
In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classified as Corrosive.
According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013, H-31339 is classified in Category 1.
Reference
Individual Scores for ocular irritation.
Irritation | Score | Hour |
| 1 | 24 |
I.Cornea |
| |
Opacity | 0 | 4 |
Area | 4 | 4 |
II. Iris |
| |
Values | 0 | 2 |
III. Conjunctivae |
| |
Redness | 1 | 2 |
Chemosis | 3 | 4 |
Discharge | 3 | 4 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Primary Eye Irritation in Rabbit:
A primary eye irritation test was conducted with rabbits to determine the potential for H-31339 to produce irritation from a single instillation via the ocular route.
At the request of the Sponsor, the study was conducted in a stepwise fashion. One-tenth of a milliliter of the test substance was instilled into the conjunctival sac of the right eye of one healthy rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the method of Draize et al.1 (see Table 4). Due to the severity of irritation noted in the treated eye, the animal was euthanized for humane reasons and the study was terminated.
Within one hour following test substance instillation, the treated eye of the animal exhibited conjunctival redness (score of 1), chemosis (score of 3), and discharge (score of 3). By 24 hours, iritis and corneal opacity also developed. Due to the severity of irritation in the treated eye, the animal was euthanized for humane reasons.
In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classified as Corrosive.
According to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Fifth revised edition 2013, H-31339 is classified in Category 1.
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available information on test item, self-classification is proposed according to the CLP or GHS.
GHS 1.
Primary Skin Irritation Test:
A primary skin irritation test was conducted with rabbits to determine the potential for H-31339 to produce irritation after a single topical application.
At the request of the Sponsor, the study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4 hours. Five-tenths of a gram of the test substance was moistened with distilled water and applied to the skin of one healthy rabbit for 4 hours. The dose site was evaluated for dermal irritation by the method of Draize et al.1 (see Table 4) immediately after patch removal and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since there was no dermal irritation noted at the dose site of this animal, the test was completed on two additional animals, as described above, except the dose sites were not evaluated immediately after patch removal.
There was no skin irritation observed at any treated site during this study.
In accordance with the provisions of Directive 67/548/EEC amended by COMMISSION DIRECTIVE 2001/59/EC of 6 August 2001, Annex VI, classification is not required based on the results of this study.
According to the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Fifth revised edition 2013 under the conditions of this study, classification is not required.
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available information on test item, no self-classification is proposed according to the CLP or GHS.
Justification for selection of irritation toxicity endpoint -
two key 1 studies used
Justification for classification or non-classification
Due to the results of the in vivo primary eye irritation study, with a conclusive outcome of being irritating, a classification is justified.
This classification has been selected on the adverse effects outcome of the key 1 study report.
GHS Category 1
The test item is not classified for skin irritation endpoint.
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