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EC number: 200-466-7 | CAS number: 60-27-5
- 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
There are two reliable studies available covering primary dermal and eye irritation potential in rabbits.
Among them an acute eye irritation/corrosion study according to OECD 405 and an acute dermal irritation study according to OECD 404. Creatinine is shown to be not irritating.
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:
- 28.01.2002 - 12.02.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 1869, 1818, 1832 g
- Housing: Housed single (male) or with two animals (female) single in steel cages with a plastic bottom mould and a habitat of 5445 square centimeters at the bottom and an overall height of 600 millimeters.
- Diet (e.g. ad libitum): The animals received food "2123" from Altromin International, Lage, Germany as pelleted diet. The food was offered ad libitum.
- Water (e.g. ad libitum): Normal tap water from municipal sources (Stätische Werke Krefeld AG, Abt. 2 TGW, 47804 Krefeld, Germany) was supplied to the animals ad libitum via bottels with rubber stoppers and steel pipes.
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C (17-23 °C)
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- To ensure that the test substance gets in close contact to the skin 0.5 g of the test substance was moistened with 0.5 mL saline solution.
- Duration of treatment / exposure:
- The test substance was removed after 4 hours exposure time.
- Observation period:
- Examination of the treated skin sites was made 1 hour, 4 hours and approximately 24, 48, 72 hours and 7 days after application of the test substance.
- Number of animals:
- one male and two females
- Details on study design:
- - 24 hours before dosing a part of the fur on both sides of the dorso-lumbal region of each animal was removed by shearing with an electrical shaving machine exposing an area of skin approximately 10 x 15 cm. Care was taken to avoid abrading the skin and only animals with healthy skin were used in the experiment
- test substance was applied to the front region of both test sites on a gauze pad (3x2 cm) each and held in place by strips of Blenderm (3 M company, St. Paul, USA). The back region behind the gauze was used as control region.
Scoring System:
see "any other information on materials and methods incl. tables" - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 3 min, 1 h, 4 h, 24 h, 48 h, 72 h and 7 d
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema and oedema and no other dermal response were observed at any time point. The numerical scores to the erythema and oedema formations are presented in table 1 under "any other information on results incl. tables"
The Primary Irritation Index was calculated to be "0" scores of maximum "8" possible scores. - Other effects:
- Systmemic toxic symptoms caused by the test substance were not observed during the whole study.
Body weight gain was positive and within the normal range. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance Creatinine was classified as "non-irritant" to skin.
- Executive summary:
Creatinine was tested regarding its irritation potential towards the skin according to OECD 404 ("Acute Dermal Irritation/Corrosion"). The potential to cause inflammatory or corrosive changes upon first contact with skin was assessed by occluded application of the test substance for four hours to the shorn skin of two male and one female rabbit, strain New Zealand White. Dermal reactions were assessed 1, 4, 24, 48, 72 hours and 7 days after removal of the test substance.
Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. No erythema and oedema and no other dermal response were observed at any time point. The Primary Irritation Index was calculated to be "0" from "8" possible scores.
Under the conditions of this study the test substance Creatinine was classified as "non-irritant" to skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Table 1: Numerical scores to the erythema and oedema formations.
|
Rabbit 1 (Female) |
Rabbit 2 (Female) |
Rabbit 3 (Male) |
||||||||||||||||||
3 min |
1 h |
4 h |
24 h |
48 h |
72 h |
7 d |
3 min |
1 h |
4 h |
24 h |
48 h |
72 h |
7 d |
3 min |
1 h |
4 h |
24 h |
48 h |
72 h |
7 d |
|
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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:
- 04.02.2002 - 19.02.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 1987.4 g, 2020.9 g and 2062.7 g
- Housing: Single housed in steel cages with a plastic bottom mould and a habitat of 5445 square centimeters at the bottom and an overall height of 600 millimeters. A non-barrier system with air was used.
- Diet: ad libitum, Supplier: Altromin International, Lage, Germany; Type: 2023; Batch No. 0733
- Water: ad libitum normal tap water from municipal sources
- Acclimation period: The animals were used for a skin irritation test before, where the test substance was classified as non-irritating. The animals were observed for their health condition, therefore it was assured that the animals were in good condition for this investigation and no acclimation period was needed.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of the test substance was applied into the right eye by pulling the lower eyelid away from the eyeball to form a cup.
- Observation period (in vivo):
- Examination of the treated eyes was made 1 hour and approximately 24, 48, 72 hours and 7 days after the application of the test substance.
- Number of animals or in vitro replicates:
- One male and two females were used.
- Details on study design:
- See "any other information on material and methods"
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Other effects:
- Systemic toxic symptoms caused by the test substance were not observed during the whole study.
Body weight gain was positive and within normal range. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the substance Creatinine could be classified as non-irritant to the eyes
- Executive summary:
The substance Creatinine was tested regarding to its irritation potential towards eyes and adjacent muscous membranes of experimental animals according to OECD Guideline No. 405 ("Acute Eye Irritation/Corrosion").
The potential to cause damage to the conjunctiva, iris and corea was assessed by single application of the test substance into the lower conjunctival sac of the eyes of two male and one female rabbit, strain New Zealand White. 0.1 g of the test substance was applied. Ocular reactions were assessed 1, 24, 48, 72 hours and 7 days after removal of the test substance. Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges.
Slight redness of the conjunctivae (injection of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on.
Under the conditions of this study the test substance Creatinine was classified as non-irritant to the eyes.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Referenceopen allclose all
The Primary Irritation Index was used to classify the test substance as follows:
0 -11: non-irritant
12 - 25: midly irritating
26 - 56: moderately irritant
57 - 110: severe irritant
The Primary Irritation Idex for Creatinine was calculated to be 4 if the maximum value after one hour exposure was chosen for calculation.
Ocular Lesions:
Slight redness of the conjunctivea (injectionn of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on. The numerical scores awarded to the ocular reactions elicited by the test substance are presented in the following table:
|
Rabbit 501(female) |
Rabbit 503 (female) |
Rabbit 502 (male) |
|||||||||||||
1h |
24h |
48h |
72h |
7d |
1h |
24h |
48h |
72h |
7d |
1h |
24h |
48h |
72h |
7d |
||
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae
|
A |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Individual body weights:
Body weight gain was positive and within normal range. The data is given in the following table:
Rabbit number and sex |
Weight at day 0 [g] |
Weight at day 7 [g] |
501 (female) |
2020.9 |
2147.0 |
503 (female) |
1987.4 |
2157.5 |
502 (male) |
2062.7 |
2155.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Creatinine is non-irritating to the skin. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 7 days. There were no significant body weight changes during the contact and observation period.
In an acute eye irritation study the potential of Creatinine to cause damage to the conjunctiva, iris and corea was assessed by a single application of the test substance. Ocular reactions were assessed 1, 24, 48, 72 hours and 7 days after removal of the test substance.
Slight redness of the conjunctivae (injection of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on. Therefore the test results indicate the absence of relevant irritation of the test substance to the cornes and the iris and only negligible potency to irritate the conjunctivae after one ocular application of the test substance Creatinine.
Justification for classification or non-classification
Creatinine is neither irritating/corrosive to the skin nor irritating to the eyes based on the results of appropriate guideline studies.
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