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EC number: 700-427-9 | CAS number: -
- 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
Atlen SK is not a skin/eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Data waiving:
- other justification
- Justification for data waiving:
- other:
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
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: New Zeland
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Reproductive Farm of Rabbits, Balice, Poland
- Age at study initiation: 5.5 months (rabbit No. 1) and 6 months (rabbits No. 2 and No. 3)
- Weight at study initiation: rabbit No. 1 - 3.3 kg, rabbit No. 2 - 3.2 kg, rabbit No. 3 - 3.0 kg
- Housing: animals were kept individually in metal cages of dimensions (length x width x height) 60 x 35 x 40 cm. The cages were equipped with lables containing information on study code, the date of the beginning and of the end of the experiment, sex and animal's number.
- Diet (e.g. ad libitum): ad libitum. The animals were fed standard granulate feed "LSK" produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz, Poland
- Water (e.g. ad libitum): ad libitum. Tap water.
- Acclimation period: 5 days quarantine
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 43 - 55 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark
IN-LIFE DATES: From: To: - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml was administered in uniluted form - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not performed
SCORING SYSTEM: according to the OECD TGD No. 405
TOOL USED TO ASSESS SCORE: the character of changes made application of any tools unnecessary - the changes were visible with a naked eye - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, as no effects were seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, as no effects were seen
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, as no effects were seen
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable, as no effects were seen
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable, as no effects were seen
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: average of 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable, as no effects were seen
- Irritant / corrosive response data:
- After administration of test item pathological changes were stated in conjunctiva of eyes of rabbits. No changes in cornea and iris were observed.
During reading after 1 hour since administration of test item erythema in form of diffuse crimson redness (individual vessels hardly visible) was stated in conjunctiva of rabbit No 1 and No 3, whereas erythema in form of diffuse beefy redness was observed in rabbit No 2. Furthermore, congestion of nictating membrane and circumcorneal injection were stated in three rabbits. Distinct swelling of conjunctiva with partial eversion of eyelids was observed in rabbit No 1 and rabbit No 3. Swelling of nictating membrane was stated in three rabbits. Excretion on lids, lids’ hair and considerable part of eye region was stated in rabbit No 1, excretion on lids and lids’ hair in rabbit No 2 and No 3.
During reading after 24 hours since administration of test item erythema in form of diffuse crimson redness, congestion of nictating membrane, circumcorneal injection as well as swelling of nictating membrane and excretion on lids and lids’ hair were stated in conjuctivas of three rabbits. Slight swelling of conjunctiva was observed in rabbit No 1 only.
During reading after 48 hours since administration of test item erythema in form of diffuse crimson redness was observed in conjunctiva of rabbit No 1, injection of some blood vessels was stated in rabbit No 2 and No 3. Congestion of nictating membrane was stated in three rabbits. Swelling of nictating membrane and slight volumes of excretion were observed in rabbit No 1 and No 2.
During reading after 72 hours since administration of test item congestion of some blood vessels and congestion of nictating membrane were stated in three rabbits. Swelling of nictating membrane and slight volumes of excretion were observed only in rabbit No 1.
During reading after 7 days since administration of test item congestion of some blood vessels was stated in rabbit No 1. No pathological changes were stated in eyes of the remaining two rabbits.
During reading after 14 days since administration of test item no pathological changes were observed in conjunctiva of rabbits.
See Table 1 in section any other information on results incl. tables for the recorded scores.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Atlen SK was tested in vivo with respect to skin/eye irritability.
In acute dermal toxicity study on rats Atlen SK did not induce any signs of local irritation at the limit concentration of 2000 mg/kg bw.
In eye irritation study on rabbit Atlen SK did not induce eye irritation.
Justification for selection of skin irritation / corrosion endpoint:
One study available.
Justification for selection of eye irritation endpoint:
One study available.
Justification for classification or non-classification
Data available for Atlen SK is conclusive but not sufficient for the classification of Atlen SK with regard to skin/eye irritation.
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