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EC number: 209-968-0 | CAS number: 599-64-4
- 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
In a skin irritation study performed per OECD Test Guideline 404 and EPA OPPTS 870.2500 the substance was non-irritating in the rabbit.
In an eye irritation study performed per OECD Test Guideline 405 the substance caused irreversible cornea, iris and conjunctival effects on the eye in the rabbit.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted per OECD Test Guideline 404 and EPA OPPTS 870.2500 following GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- US EPA 40 CFR, Part 792 and OCED GLPs, 1996
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Male and female New Zealand White rabbits, at least 10 weeks of age, weighing 2.15 to 2.21 kg were obtained from Millbrook Breeding Labs. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages with hardwood chip bedding. They were provided rabbit diet and tap water ad libitum. Room temperature was 68+/-5 degrees F and the relative humidity ranged between 30-70%. Room lights were on a 12-hour light/dark cycle.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Three rabbits were dosed with 0.5 g of PCP on a small area, approximately 6 cm², of skin on the shaved trunk. A gauze patch was placed over the area and secured with non-irritating tape.
- Duration of treatment / exposure:
- The exposure time was four hours.
- Observation period:
- Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period. Daily clinical observations included all toxicologic and pharmacologic signs.
- Number of animals:
- Three
- Irritation parameter:
- other: erythema and edmea score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: No erythema or edema observed
- Irritant / corrosive response data:
- No erythema/edema was observed for any animal at any time period.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, PCP is considered to be a non-irritant.
Reference
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:
- 1988-January-12 to 1998-February-2
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD method 405
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Examinations were not made on days 7 and 14 after application as outlined by the guideline. Alternatively examinations were conducted on days 6, 8, 10, 13, and 17. This deviation did not negatively affect the validity of the test.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: individually in cages
- Diet: fed K4 Alleindiaet for rabbits, Ssniff Special Feed GmbH (4770 Soest), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ±1 degrees C
- Humidity: 60% ±5%
- Air changes: 15/hour
- Photoperiod: 12 hours light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount: The eyelid was lifted and 0.1 g of the test substance was applied to the conjunctival sac of the right eye. (The left eye was treated in one animal.) - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after the application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Seventy-two hours after the application the treated eyes were rinsed with a sodium fluorescein solution to examine corneal damage and were rinsed with a warm physiological saline (sodium chloride) solution.
- Time after start of exposure: 72
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: eye lamp and fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 41.1
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks on result:
- other: The effects of the test substance on the eye increased over the 21 day observation period, particularly in the cornea.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, PCP is considered to cause irreversible effects to the eye of Russian rabbits. The effects of the test substance on the eye increased over the 21 day observation period, particularly in the cornea.
Reference
Individual Irritation Scores |
||||||||||||||||||||
Corneal Assessment |
||||||||||||||||||||
|
1 hour |
24 hour |
48 hours |
72 hours |
6 days |
8 days |
10 days |
13 days |
17 days |
21 days |
||||||||||
|
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
A,B |
AxBx5 |
Animal 1 |
1,4 |
20 |
1,4 |
20 |
1,4 |
20 |
1,4 |
20 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
Animal 2 |
1,4 |
20 |
2,4 |
40 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
2,3 |
30 |
3,3 |
45 |
Animal 3 |
1,4 |
20 |
1,4 |
20 |
2,4 |
40 |
2,4 |
40 |
2,4 |
40 |
2,4 |
40 |
2,4 |
40 |
2,4 |
40 |
2,4 |
40 |
3,4 |
60 |
Mean |
|
20.00 |
|
26.67 |
|
30.00 |
|
30.00 |
|
33.33 |
|
33.33 |
|
33.33 |
|
33.33 |
|
33.33 |
|
45.00 |
A Opacity |
||||||||||||||||||||
Iris Assessment |
||||||||||||||||||||
|
1 hour |
24 hour |
48 hours |
72 hours |
6 days |
8 days |
10 days |
13 days |
17 days |
21 days |
||||||||||
|
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
A |
Ax5 |
Animal 1 |
0 |
0 |
1* |
5 |
0 |
0 |
0 |
0 |
c1 |
5 |
c1 |
5 |
stc1 |
5 |
stc1 |
5 |
stc1 |
5 |
stc1 |
5 |
Animal 2 |
0 |
0 |
1* |
5 |
1* |
5 |
1* |
5 |
xc1 |
5 |
c1 |
5 |
stc1 |
5 |
stc1 |
5 |
stc1 |
5 |
stc1 |
5 |
Animal 3 |
0 |
0 |
1* |
5 |
1* |
5 |
1* |
5 |
xc1 |
5 |
c1 |
|
stc1 |
5 |
stc1 |
5 |
stc1 |
5 |
|
5 |
Mean |
|
0.00 |
|
5.00 |
|
3.33 |
|
3.33 |
|
5.00 |
|
5.00 |
|
5.00 |
|
5.00 |
|
5.00 |
|
5.00 |
A Iris Score |
||||||||||||||||||||
Conjunctiva Assessment |
||||||||||||||||||||
|
1 hour |
24 hour |
48 hours |
72 hours |
6 days |
8 days |
10 days |
13 days |
17 days |
21 days |
||||||||||
|
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
A,B,C |
A+B+Cx2 |
Animal 1 |
2,1,2 |
10 |
3,2,2 |
14 |
!3,1,2 |
12 |
!3,1,2 |
12 |
2,1,0 |
6 |
2,1,0 |
6 |
2,1,0 |
6 |
2,1,0 |
6 |
2,1,0 |
6 |
2,1,0 |
6 |
Animal 2 |
2,1,2 |
10 |
3,2,2 |
14 |
!3,2,2 |
14 |
!3,1,2 |
12 |
#3,1,0 |
8 |
3,1,2 |
12 |
2,1,0 |
6 |
2,1,0 |
10 |
2,1,2 |
10 |
2,1,0 |
6 |
Animal 3 |
2,1,2 |
10 |
3,2,2 |
14 |
!3,1,2 |
12 |
!3,1,2 |
12 |
#3,1,0 |
8 |
3,1,1 |
10 |
2,1,0 |
6 |
2,1,1 |
6 |
2,1,0 |
6 |
2,1,0 |
6 |
Mean |
|
10.00 |
|
14.00 |
|
12.67 |
|
12.00 |
|
7.33 |
|
9.33 |
|
6.00 |
|
7.33 |
|
7.33 |
|
6.00 |
A Redness |
The average of the maximum values for all experimental animals is reported as X(bar) The average for all assessment time points was corresponded to the irritation index, which was compared to the following classification scheme:
0-10 not irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating
Per Annex VI of 79/831/EEC, the average scores for cornea, iris and conjunctivae at 24, 48 and 72 hour were determined.
Results according to Annex VI:
Cornea: X(bar) = 1.56
Iris: X(bar) = 0.78
Conjunctiva:
Redness: X(bar) = 3.00
Chemosis: X(bar) = 1.44
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The skin irritation potential was investigated in a study performed per OECD Test Guideline 404 and EPA OPPTS 870.2500 under GLP conditions (Toxikon Corporation, 2002).
Three New Zealand White rabbits were dosed with 0.5 g of the neat test substance under semi-occlusive conditions for 4 hours.
Under the conditions of this study, PCP is considered to be a non-irritant.
Eye irritation
The key study was conducted according to OECD method 405 (Hüls, 1988).
Three Russian rabbits were dosed with 0.1 g of the neat test substance and the eyes were examined at 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after the application.
Under the conditions of this study, PCP is considered to cause irreversible effects to the eye. The effects of the test substance on the eye increased over the 21 day observation period, particularly in the cornea.
The supporting study was conducted per OECD 405 and EPA OPPTS 870.2400 under GLP conditions (Toxikon Corporation, 2002).
Three New Zealand White rabbits were dosed with 0.1 mL of PCP per eye. Eye irritation scores were recorded at 1, 24, 48 and 72 hours post-dose. Following the 24-hour observation, the treated eyes were rinsed.
Under the conditions of this study, PCP is considered to be a non-irritant to rabbit eyes.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available.
Justification for selection of eye irritation endpoint:
Two studies are available. The study which resulted in classification was selected as key.
Effects on eye irritation: corrosive
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin irritation.
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does require classification with respect to eye irritation as Category 1 (H318: Causes serious eye damage).
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.
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