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EC number: 208-796-3 | CAS number: 542-02-9
- 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 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. Acetoguanamine is shown to be non 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:
- 1989-10-31 till 1989-11-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions; Guideline study (OECD 404; Irritant effects on rabbit skin) according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: idividually in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet (ad libitum)
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: "the rabbit selected were all acclimated to the laboratory environment", but no data on time period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 19 per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hours period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Acetoguanamine
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water
- Lot/batch no. (if required): 10/08/89 AG
- Purity: 99.2 % - Duration of treatment / exposure:
- four hours
- Observation period:
- Examintation of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.
- Number of animals:
- three
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: 2.5 cm square gauze pad
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treatment site was washed using water to remove any residual test substance
- Time after start of exposure: four hours
SCORING SYSTEM:
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erytehma
4: Severe erythema (beet redness) to slight eschar formation(injuries in depth)
Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 30 minutes after removal of the patches and on days 2, 3 and 4
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 30 minutes after removal of the patches and on days 2, 3 and 4
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 30 minutes after removal of the patches and on days 2, 3 and 4
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 30 minutes after removal of the patches and on days 2, 3 and 4
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 30 minutes after removal of the patches and on days 2, 3 and 4
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 30 minutes after removal of the patches and on days 2, 3 and 4
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The treated skin of all three animals was scored for erythema and oedema. The test substance caused no adverse effects to the skin.
- Other effects:
- None of the animals showed any response to treatment throughout the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EEC Directive 83/467/EEC Annex VI Part II
- Conclusions:
- In a dermal irritation study according to OECD 404 three New Zealand White strain rabbits were semi-occlusive dermally exposed to 0.5 g Acetoguanamine for four hours. Examination of the treated skin was made on Day 1 (i.e. approx. 30 minutes after removal of the test substance) and on Day 2, 3 and 4. None of the animals showed any response to treatment throughout the observation period.
Therefore no classification for skin irritation is required for Acetoguanamine. - Executive summary:
In a dermal irritation study according to OECD 404 three New Zealand White strain rabbits were semi-occlusive dermally exposed to 0.5 g of Acetoguanamine for four hours. Examination of the treated skin was made on Day 1 (i.e. approx. 30 minutes after removal of the test substance) and on Day 2, 3 and 4. None of the animals showed any response to treatment throughout the observation period. Therefore no classification for skin irritation is required for Acetoguanamine.
Reference
Table 1: Dermal reactions elicited by Acetoguanamine.
Rabbit Number and Sex |
Bodyweight (Day 1) |
E = Erythema O = Oedema |
Day |
|||
1* |
2 |
3 |
4 |
|||
803 (female) |
2525 g |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
804(female) |
2650 g |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
805(female) |
2670 g |
E O |
0 0 |
0 0 |
0 0 |
0 0 |
* Approximately 30 minutes after removal of the dressing
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:
- 1989-11-06 till 1989-11-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Reliable without restrictions; Guideline study (OECD 405) according to GLP
- 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: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 13 weeks of age
- Weight at study initiation: 2.8 to 3.0 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): free access to SDS Standard Rabbit Diet
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: yes, but no period of time mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): lightning was controlled to give 12 hours of artificial light (0700-1900 hours) in each 24 hour period. - Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- Approx. 85 mg of Acetoguanamine, the weight occupying a volume of 0.1 ml.
- Duration of treatment / exposure:
- Acetoguanamine was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.
- Number of animals or in vitro replicates:
- three
- Other effects:
- The numerical scores awarded to the ocular reactions elicited by Acetoguanamine, are given in Table 1.
A corneal opacity developed in one animal 24 h after instillation and was still visible 4 d following instillation. The opacity had resolved 7 days after instillation.
No iridial inflammation was seen throughtout oberservation period.
A diffuse crimson-red colouration of the conjunctivae was observed, 1 h after instillation only, in all three animals.
All conjuctival reactions had resolved 24 or 48 h after instillation. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acetoguanamine elicites transient, corneal opacification and temporary well-defined conjuctival reactions. Nevertheless this effects do not lead to a classification of the test substance.
- Executive summary:
In an eye irritation study according to OECD 405 approx. 85 mg of Acetoguanamine, the weight occupying a volume of 0.1 mL was placed into the lower lid of one eye of each of the test animals (three adult New Zealand White rabbits). Examination of the eyes was made after 1 hour, and 1, 2, 3, 4 and 7 days after instillation. Irritation was scored and it was determined that Acetoguanamine elicites only transient, corneal opacification and temporary well-defined conjuctival reactions. Nevertheless this effects do not lead to a classification of the test substance.
Reference
TABLE 1: Ocular reactions elicited by Acetoguanamine.
Rabbit Number and Sex |
Bodyweight (Day 1) |
Region of Eye |
One hour |
Day after instillation |
||||||
1 |
2 |
3 |
4 |
7 |
||||||
812 female |
2980 g |
Corea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Conjunctivae |
Redness |
2 |
0 |
0 |
0 |
0 |
0 |
|||
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
||||
838 female |
2870 g |
Corea |
Density |
0 |
0 |
0 |
0 |
0 |
0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Conjunctivae |
Redness |
2 |
0 |
0 |
0 |
0 |
0 |
|||
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
||||
839 female |
3000 g |
Corea |
Density |
0 |
2 |
1 |
1 |
1 |
0 |
|
Area |
0 |
1 |
1 |
1 |
1 |
0 |
||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
||||
Conjunctivae |
Redness |
2 |
1 |
0 |
0 |
0 |
0 |
|||
Chemosis |
1 |
1 |
0 |
0 |
0 |
0 |
SCORING SYSTEM:
Cornea:
Opacity: degree of density (area most dense taken from reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity
Area of cornea involved:
1 One quarter (or less) but not zero
2 Greater than one quarter, but less then half
3 Greater than half, but less than three quarters
4 Greater than three quarters, up to whole area
Iris:
0 Normal
1 Markedly depened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic (injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red
Chemosis (lids and/or nictitating membranes)
0 No swelling
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In an acute skin irritation/corrosion study Acetoguanamine did not show any irritating effects on the intact skin after a contact time of 4 hours. Further no skin reactions were recorded throughout the observation period of 4 days.
In an acute eye irritation study Acetoguanamine elicited transient corneal opacification in one animal and a transcient but well-defined conjunctival reaction in all three animals. Nevertheless this was not relevant for classification.
Justification for classification or non-classification
Acetoguanamine is neither irritating/corrosive to the skin nor irritating to the eyes based on the results of appropriate guideline studies.
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