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EC number: 203-813-0 | CAS number: 110-89-4
- 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:
(1) Rabbit, shaved, undiluted test item, occlusive, 3 min, washing:
corrosive (non-GLP, OECD 404, BASF 77/283-3, 1982).
(2) Rabbit, occlusive, 3, 60 min, 4 hours, washing: corrosive (non-GLP,
DOT Guideline, Toxikon, 1991).
(3) Rabbit, clipped, undiluted test item, occlusive, 4 hours, washing:
corrosive (non-GLP, DOT Guideline, Biosearch, 1983).
(4) Rabbit, clipped, occlusive, treatment duration unknown: corrosive
(non-GLP, non-Guideline, Smyth et al., 1962).
Eye:
(1) Rabbit, undiluted: irritating, risk of serious damage to eyes
(non-GLP, non-Guideline, Sugai et al., 1962).
(2) Rabbit, undiluted: irritating, risk of serious damage to eyes
(non-GLP, non-Guideline, Smyth et al., 1962).
The undiluted test item was corrosive to the skin of rabbits, caused
serious damage to the eye of rabbits and was reported to induce
respiratory irritation.
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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive conditions
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Piperidine
- Substance-No.: 77/283
- Physical state: liquid
- Analytical purity: 99 %
- Expiration date of the lot/batch: september 1982 - Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach am Main, Germany
- Weight at study initiation: 2.39 kg (male); 2.96 kg (female)
- Housing: single
- Diet: Ovator Solikanin 4 mm, Muskator-Werke, Duesseldorf, Germany; ca. 130 g per animal, daily.
- Water: Deionized water (monday to friday); Tap water (weekend); ca 250 ml per animal
- Acclimation period: ca. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 3 min, 1 h, 4 h
- Observation period:
- 8 days
- Number of animals:
- 2 (one female and one male)
- Details on study design:
- TEST SITE
- Area of exposure: area of 2.5*2.5 cm on the upper third of the back
- Type of wrap if used: moistened cotton lint, no further data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol, Lutrol:water (1:1)
- Time after start of exposure: 3 min, 1 h and 4 h
SCORING SYSTEM: According to JH Draize: Dermal Toxicity, in: Appraisal of the saftety of chemicals in foods, drugs and cosmetics. p 46 - 59, 1959. Washington, DC: The Association of Food and Drug Officials of the United States of America, Texas, State department of Health.
READINGS
- 15 to 30 minutes after remove of the test substance, as well as after 24, 48 hours and 8 days after application. 8 day reading only with treatment duration of 4 hours.
OTHER
- In case of clinical indication of necrosis, this will be confirmed by macroscopic-pathologic evaluation. - Irritation parameter:
- other: Necrosis
- Remarks on result:
- other: Exposure duration of 3 min led to hard leathery necrosis observed after 24 hours.
- Irritation parameter:
- erythema score
- Remarks:
- (exposure duration: 3 min)
- Basis:
- mean
- Remarks:
- (animal 1 and 2)
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Necrosis (leathery, hard), macroscopic-pathologic confirmation
- Irritation parameter:
- edema score
- Remarks:
- (exposure duration: 3 min)
- Basis:
- mean
- Remarks:
- (animal 1 and 2)
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (exposure duration: 1 h)
- Basis:
- mean
- Remarks:
- (animal 1 and 2)
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Necrosis (leathery, hard), macroscopic-pathologic confirmation
- Irritation parameter:
- edema score
- Remarks:
- (exposure duration: 1 h)
- Basis:
- mean
- Remarks:
- (animal 1 and 2)
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- (exposure duration: 4 h)
- Basis:
- mean
- Remarks:
- (animal 1 and 2)
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Remarks on result:
- other: Necrosis (leathery, hard and extending beyond the area of application), macroscopic-pathologic confirmation
- Irritation parameter:
- edema score
- Remarks:
- (exposure duration: 4 h)
- Basis:
- mean
- Remarks:
- (animal 1 and 2)
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritant / corrosive response data:
- The undiluted test substance was applied for 3 min, 1 and 4 h under occlusive conditions to the backs of two rabbits each.Thick and leathery necroses were observed after exposure duration of 3 min; the findings were confirmed histologically.
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- different scoring method
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: Piperidine, Test substance No. 114
- no further data - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Takeo breeder (Shizuoka, Japan)
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: metal cages
- Diet: RC4 diet (Oriental Yeas Co., Tokyo, Japan), ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according.to the Draize score (Draize JH, Woodard G and Galvery H0 (1944); Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmcol. Exp. Ther., 82, 377-390).
READINGS: The eyes were examined and the grade of ocular reaction was recorded 1, 4, 24, 48, 72, 96hr, 7, 14 and 21 days after the treatment. - Irritation parameter:
- other: irreversible eye damage
- Remarks on result:
- other: Eye damage score about 86.1 of 110 that persists for more than 21 days after treatment.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In the key study, a non-GLP dermal irritation study similar to OECD 404 (BASF 77/283-3, 1982) one male and one female Vienna White rabbit (breeder) of 2.39 and 2.96 kg, respectively, were dermal exposed to 0.5 mL of the undiluted test item (purity: 99%) to an area of 6.25 cm² on the upper third of the back. Test sites were covered with an occlusive dressing for 3 min, 1 or 4 hours. Readings were performed 15 to 30 minutes after remove of the test substance and washing of the skin, as well as after 24, 48 hours. Animals were observed for 8 days. Irritation was scored by the method of Draize (Draize JH: Dermal Toxicity. 1959).
In animals treated for 3 min, 1 and 4 hours erythema score of 4, as well as hard leathery, macroscopic-pathological confirmed necrosis were detectable after 24 hours.
The skin irritation study is acceptable (reliability 2), and does not fully satisfy the guideline requirements for a skin irritation study (OECD 404) in rabbits (occlusive conditions).
In the key study, the test item is corrosive to the skin based on hard, leathery, macroscopic-pathologically confirmed necrosis observed after 3 min exposure at the reading time point of 24 hours in both animals.
In a non-GLP skin irritation study conducted by Toxikon (1991) according to the DOT guidelines (1987), 0.5 mL of the test item of unknown concentration was applied to an area of ca. 3 cm³ of intact skin of 6 albino rabbits (strain unknown). Test sites were covered with an occlusive dressing for the exposure period of 3 or 60 min or 4 hours. After removal of the test substance and washing of the skin, readings were performed at 30 minutes, as well as at 48 hours. Animals were observed for 48 hours. Tissue destruction, necrosis, occurred for all 3 exposure periods (3 and 60 min and 4 hours), at all test sites, with all 6 rabbits tested. Reading time point of the result was not given.
The skin irritation study is acceptable (reliability 2), but does not satisfy the guideline requirements for a skin irritation study (OECD 404) in rabbits (occlusive conditions, no readings after 24 and 72 hours, no purity of the test compound given).
The test substance is thus considered corrosive to the skin of rabbits based on necrosis following at least 3 min exposure as observed in all six animals.
In a further non-GLP dermal irritation study (Biosearch, 1983) according to the DOT guideline for Corrosivity, six New Zealand White rabbits were dermally exposed to 0.5 mL of the undiluted test item to an area of 2.54 cm² of the clipped skin. Test sites were covered with an occlusive dressing for 4 hours. After removal of the test substance and washing of the skin, readings were performed after 24 and 48 hours. Animals were observed for 48 hours. Severe erythema and corrosivity was observed 24 and 48 hours after treatment.
The skin irritation study is acceptable (reliability 2), but does not satisfy the guideline requirements for a skin irritation study (OECD 404) in rabbits (occlusive conditions, no reading after 72 hours, no purity of the test compound given).
The test substance is considered corrosive to the skin of rabbits after 4 hours exposure at the reading time point of 24 hours in all six animals.
Smyth et al. (1962) reported a dermal skin irritation study at which the clipped skin of five albino rabbits was exposed uncovered to 0.01 mL of the test item. The animals were observed for 24 hours. Within 24 hours after application of the test item, a primary skin irritation grade of 6 of 10 grades indicates necrosis.
The skin irritation study is acceptable (reliability 2), but does not satisfy the guideline requirements for a skin irritation study (OECD 404) in rabbits (no readings after 48 and 72 hours, no purity of the test compound given).
Due to the primary skin irritation grade 6 of 10 within 24 hours, after application of 0.01 ml undiluted test substance, the test substance is considered to cause severe damage to the eye.
Eye irritation
In the key study, Sugai et al. (1990) performed a Draize test. 0.1 ml of undiluted test item was instilled to the eye of three rabbits. The animals were observed for 21 days. Scoring was performed according to Draize et al., 1944 (J. Pharmcol. Exp. Ther., 82, 377-390). Readings were conducted 1, 4, 24, 48, 72, 96 hours, 7, 14 and 21 days after the treatment. An eye damage score of about 86.1 of 110 was observed that persisted for more than 21 days after treatment.
The eye irritation study is acceptable (reliability 2), but does not fully satisfy the guideline requirements for an eye irritation study (OECD 405) in rabbits (limited documentation, different scoring system).
Due to the irreversible eye damage the test substance is considered to cause severe damage to the eye.
Smyth et al. (1962) reported an eye irritation study in which 0.005 ml of a 5 and 1 % solution of the test item was instilled to the eye of rabbits. The animals were observed for 24 hours. Within 24 hours after application of the test item, an irritation score of 9 of 10 grades indicates a > 87 % necrosis after instillation of 0.005 ml of 5 % solution and 63 - 87 % necrosis after instillation of 1 % solution.
The eye irritation study is acceptable (reliability 2), but does not satisfy the guideline requirements for an eye irritation study (OECD 405) in rabbits (limited documentation, different scoring system).
Due to the eye irritation grade 9 of 10 within 24 hours, after application of the test substance, the test substance is considered corrosive.
Respiratory system
There are no data available concerning the irritating potential to the respiratory system. Nevertheless, the test item is corrosive and causes burns. Irritating to the respiratory system is implicit. This is confirmed by human data. The irritation threshold for humans was reported as 90 mg/m³ (26 ppm), which is considered as LOAEL. Inhalation exposure to piperidine causes sore throat, signs of respiratory tract irritation (coughing, labored breathing), and dizziness (DASE (Dutch Association of Safety Experts), 1980). Piperidine. In: Handling Chemicals Safely - 1980. 2nd ed. Published by: Dutch Assoc. of Safety Factors, Dutch Chemistry Industrial Association, and Dutch Safety Institute. p. 757.). No exposure concentrations were provided.
Conclusion: The undiluted test item was corrosive to the skin of rabbits, caused serious damage to the eye in rabbits and was reported to induce respiratory irritation.
Justification for selection of skin irritation / corrosion
endpoint:
Study comparable to guideline with acceptable restrictions (Klimisch
code 2). Analytical purity of the test substance is given in the report
(99 %) of the key study. No purity is given in the report of the
supporting study of Toxikon 1991.
Justification for selection of eye irritation endpoint:
Study of highest quality.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The substance is already listed in Annex VI to Regulation (EC) No 1272/2008 and classified with Cat. 1B (H314, Causes severe skin burns and eye damage).
Additionally, the available experimental test data for irritation/corrosion are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. As a result the substance is considered to be classified for irritation/corrosion (Cat 1B, H314, Causes severe skin burns and eye damage ) under Regulation (EC) No.1272/2008 and therefore confirming the classification in Annex VI to Regulation (EC) No 1272/2008.
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