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Diss Factsheets
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EC number: 237-222-4 | CAS number: 13701-59-2
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Studies of skin and eye irritation are available in the rabbit with the submission substance
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:
- 19 December, 1978 - 31 January, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Conducted prior to GLP, and the availabilty of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature and humidity, the quantity of test suibstance applied if a patch was used, the surface of the patch, how the patch was kept in contact with the skin)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males2390 - 2586 g, females 2190 - 2570 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 08/02/1979 To:11/02/1979 - Type of coverage:
- not specified
- Preparation of test site:
- abraded
- Vehicle:
- other: wetted with 0.9% saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
VEHICLE
- Amount(s) applied (volume or weight with unit): wetted with 0.9% saline
- Purity: no data - Duration of treatment / exposure:
- 72 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 male and 3 female)
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.04
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No further data
- Other effects:
- No further data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material did cause irritation or corrosion to the skin and therefore is not classified for skin irritation/corrosion according to EU criteria
- Executive summary:
In a study conducted in 1979, the test substance Busan 11-M1was examined for its ability to cause skin irritation when tested on intact and abraded rabbit skin. The exposure sites on each animal were shaved and then two sites were left intact and two sites were abraded prior to exposure. The test substance wetted with saline was applied under a gauze pad to the sites. The skin reactions of each test animal were observed for 72 hours. Slight erythema with developed which was fully reversible and was not accompanied by any other irritation reactions. Under the conditions of this study, the test substance Busan 11-M1was considered not to be irritating to intact or abraded rabbit skin. Based on these results, the test substance does not warrant classification for skin irritation in accordance with Regulation EC No. 1272/2008.
Reference
No further data
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:
- weight of evidence
- Study period:
- 12 December, 1978 - 4 January, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The quantiy of test material instilled in the sac of the eyes is not known. The study should have been carried out beyond 7 days to show reversibility in the animal that showed corneal opacity. Conducted prior to GLP, and the availability of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature, humidity, how the test substance is instilled etc...).
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Eye irritation was tested in 3 rabbits. Test substance was instilled into the eyes of the rabbits. The eyes were then washed for 1 minute with lukewarm water 30 seconds after instillation of the test material. The rabbits were observed for 72 hours. Corneal opacity and area, iris, and conjunctivae redness, chemosis and discharge were scored at the 24 hour, 48 hour, 72 hour and 7 day time points.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males 2610 - 3058 g, female 3618 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 88/12/1979 To: 04/01/1979 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 (2 male and 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were then washed for 1 minute with lukewarm water
- Time after start of exposure: 30 seconds
SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas
TOOL USED TO ASSESS SCORE: No data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0.55
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: A further timepoint may have established reversibility
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 timepoints
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No further data
- Other effects:
- No further data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material caused mild and transient irritation to the eyes which is expected to be fully reversible and therefore is not classified for eye irritation/corrosion.
- Executive summary:
In a study conducted in 1979, the potential of the test substance Busan 11-M1to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. After 30 seconds, the eyes were washed for 1 minute with lukewarm water. The test animals were observed for 7 days after instillation. Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, the conjunctival irritations had resolved by 7 days after instillation and it is expected that the cornea opacity would be fully reversible also, had the further time point of 14 days been examined. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.
Reference
No further data
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation/Corrosion
In a study conducted in 1979, the test substance Busan 11-M1 was examined for its ability to cause skin irritation when tested on intact and abraded rabbit skin. The exposure sites on each animal were shaved and then two sites were left intact and two sites were abraded prior to exposure. The test substance wetted with 0.95 saline was applied under a gauze pad to the sites. The skin reactions of each test animal were observed for 72 hours. Slight erythema with developed which was fully reversible and was not accompanied by any other irritation reactions. Under the conditions of this study, the test substance Busan 11-M1was considered not to be irritating to intact or abraded rabbit skin. Based on these results, the test substance does not warrant classification for skin irritation in accordance with Regulation EC No. 1272/2008.
Eye Irritation/Corrosion
In a study conducted in 1979, the potential of the test substance Busan 11-M1 to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. After 30 seconds, the eyes were washed for 1 minute with lukewarm water. The test animals were observed for 7 days after instillation. Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, the conjunctival irritations had resolved by 7 days after instillation and it is expected that the cornea opacity would be fully reversible also, had the further time point of 14 days been examined. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.
In a further study conducted in 1979, the potential of the test substance Busan 11-M1 to cause irritation to the eyes was determined in rabbits. Six New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. The test animals were observed for 7 days after instillation. Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, all reactions had resolved by 7 days after instillation. Under the conditions of this study, the test substance Aldehyde C8 was determined to be irritating when tested in rabbit eyes. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available for this endpoint
Justification for selection of eye irritation endpoint:
A weight of evidence approach if followed for this endpoint.
Justification for classification or non-classification
The test material did cause significant irritation or corrosion to the skin or eyes and therefore is not classified for skin or eye irritation/corrosion according to the CLP Regulation.
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.
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