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EC number: 308-208-6 | CAS number: 97925-95-6
- 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
The skin irritation/corrosion studies revealed that Atmer 163 is corrosive to the skin of rabbits.
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:
- other: Comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Open application, 72 h observation is missing
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, UK
- Weight at study initiation: 2.5-3.0 kg
- Housing:In satinised aluminium steel cages (605 mm width x 490 mm depth x 455 mm height) with one animal per cage
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 50-60 - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%
- Duration of treatment / exposure:
- 3 minutes
- Observation period:
- Immediately after washing and 2, 24, 48 and 96 h after treatment
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Whole flank
REMOVAL OF TEST SUBSTANCE
- Washing (if done): By gentle swabbing with cotton wool soaked in lukewarm water
- Time after start of exposure: 3min
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average 24 and 48h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average 24 and 48h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average 24 and 48h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: average 24 and 48h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: average 24 and 48h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: average 24 and 48h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: average 24 and 48h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: average 24 and 48h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: average 24 and 48h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: average 24 and 48h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: average 24 and 48h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: average 24 and 48h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96h
- Irritant / corrosive response data:
- All animals showed signs of necrosis nintety-six hours after application; these included, typically, thickening of the skin at the application site, eschar formation and blanching and one animal had darkened skin at the appliction site (see table 2).
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Undiluted Synprolam 35x2 when administered to rabbit skin for 3 min is corrosive to one out of 6 animals after 48h observation time and 6 out of 6 animals after 96 h observation time and therefore is classified:
CLP: Category 1B, H314 (causes severe skin burns)
Reference
Table 1: Corrosive reactions
Number of animals with corrosion/all tested animals after |
||
3min |
24h |
48h |
0/6 |
0/6 |
1/6 |
Table 2: Skin corrosion parameters
|
Thickened skin after |
Blanched skin after |
Hardened skin after |
Darkened skin after |
||||||||
Animal number |
24h |
48h |
96h |
24h |
48h |
96h |
24h |
48h |
96h |
24h |
48h |
96h |
1 |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2 |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3 |
- |
+ |
+ |
- |
- |
- |
- |
+ |
+ |
- |
+ |
+ |
4 |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5 |
- |
+ |
+ |
- |
- |
+ |
- |
- |
- |
- |
- |
- |
6 |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
Cracked skin after |
Wrinkled skin after |
Eschar formation after |
||||||
Animal number |
24h |
48h |
96h |
24h |
48h |
96h |
24h |
48h |
96h |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
3 |
- |
- |
- |
- |
- |
- |
- |
+ |
+ |
4 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5 |
- |
- |
- |
- |
+ |
- |
- |
- |
- |
6 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A skin irritation study similar to OECD guideline 404 was performed with white rabbits (CTL-T-1522). 6 animals were treated with 0.5 mL of the undiluted test substance for 3 minutes by an open application to the skin. The reactions were observed immediately after washing and 2, 24, 48 and 96 hours after treatment. All animals showed signs of necrosis ninety-six hours after application; these included, typically, thickening of the skin at the application site, eschar formation and blanching and one animal had darkened skin at the application site. None of the animals died or showed any systemic effects. Undiluted test substance when administered to rabbit skin for 3 minutes is corrosive to one out of 6 animals after 48 hours observation time and 6 out of 6 animals after 96 hours observation time and has therefore to be classified.
A further skin irritation study similar to OECD guideline 404 was performed with white rabbits (CTL/T/1357). The skin of 6 animals was treated with the undiluted test substance for 4 hours. The way of dermal application was not specified. The reactions were observed after 4, 24 and 48 hours. After 4 hours no reactions had been reported. Five out of six rabbits had visible signs of necrosis at the 24 hour observation, after 48 hours all animals were showing signs of necrosis. None of the animals died or showed any systemic effects. Undiluted test substance when administered to rabbit skin for 4 hours is corrosive to 6 out of 6 animals after 48 hours observation time and has therefore to be classified.
According to REGULATION (EC) No 1907/2006 Annex VIII 8.2.1 column 2 an
eye irritation study does not need to be conducted if the substance is
classified as corrosive to the skin.
Justification for classification or non-classification
3 minutes dermal exposure of Atmer 163 to rabbit skin resulted in corrosive effects. 1 out of 6 animals after 48 hours and 6 out of animals after 96 hours showed corrosion of the skin. Additionally the supporting study revealed necrosis in all treated animals after a 4 hour dermal application. According to CLP (1272/2008/EC), Atmer 163 has to be classified as:
CLP: Category 1B, H314 (causes severe skin burns)
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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