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EC number: 204-535-2 | CAS number: 122-34-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 November - 17 December 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not available at the time the study was conducted. Since an appropriate guinea pig maximisation test is available it can not be justified to conduct an additional LLNA study due to animal welfare reasons.
Test material
- Reference substance name:
- Simazine
- EC Number:
- 204-535-2
- EC Name:
- Simazine
- Cas Number:
- 122-34-9
- Molecular formula:
- C7H12ClN5
- IUPAC Name:
- 6-chloro-N2,N4-diethyl-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test material: Simazine a.i.
- Appearance: White powder
- Lot No.of test material: 74
- Expiration date of the batch: September 1996
- Purity: 97.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the dark at 4°C
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Microbiological status of animals, when known:
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 286 - 366 g
- Housing: Groups of 5 animals in suspended metal cages with wire mesh floors
- Diet: Vitamin C enriched guinea-pig diet FD2 available ad libitum. Hay was given weekly.
- Water: available ad libitum
- Acclimation period: 12 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours light (0700 - 1900) : 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- coconut oil
- Concentration / amount:
- 10% w/v
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Concentration / amount:
- 50% w/v
- Day(s)/duration:
- 48 hours
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Concentration / amount:
- 50% and 25% w/v
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control: 5 animals
Test animals: 10 animals - Details on study design:
- The test substance was prepared prior to each application on the day of dosing in Alembicol D (a product of coconut oil).
RANGE FINDING TESTS:
A preliminary study was performed to identify where possible:
a). concentrations of the test substance that would produce irritation suitable for the induction phase of the main study: The test material was administered by intradermal injections at concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10.0 %w/v in Alembicol D in 2 animals.
b). a maximum non-irritant concentration by the topical route of administration for the challenge phase: The test material was administered by topical application at concentrations of 10.0, 20, 30 and 50 %w/v in Alembicol D in 4 animals.
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL INJECTIONS:
- No. of exposures: 2 replicates of each injectable per animal (i.e. applied to both left and right injection sites); 10 animals tested
- Test groups: Injectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation.
2. Simazine a.i., 10% w/v in Alembicol D
3. Simazine a.i., 10% w/v in a 50:50 mixture of Freund's complete adjuvant and Alembicol D
A volume of 0.1 mL was injected into both the left and right injection sites.
- Control group: 5 control animals were treated similarly to the test animals and were injected with the following test solutions:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation.
2. Alembicol D
3. Freund's complete adjuvant 50:50 with Alembicol D
- Site: A 40 x 60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20 x 40 mm area within the clipped area.
- Concentrations: 10% w/v in Alembicol D
A. INDUCTION EXPOSURE - TOPICAL APPLICATIONS:
- No. of exposures: 2 replicates of each solution (i.e. applied to both left and right sites); 10 animals tested
- Exposure period: 48 hours
- Test groups: Treated with approximately 0.4 mL of Simazine a.i., 50% w/v in Alembicol D.
- Control group: 5 control animals were treated similarly to the test animals with the following solutions:
1. Freund's complete adjuvant was diluted with an equal volume of water for irrigation.
2. Alembicol D
3. Freund's complete adjuvant 50:50 with Alembicol D
- Site: Six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 0.2 mL per site of 10% w/w sodium lauryl sulphate in petrolatum. 24 hours later a 20 x 40 mm patch of paper was saturated with approximately 0.4 mL of Simazine a.i., 50% w/v in Alembicol D. The patch was placed on the skin of the test animals and covered by a length of impermeable plastic adhesive tape. This in turn was firmly secured by elastic adhesive bandage wound around the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape.
- Duration: The dressing was left in place for 48 hours.
- Concentrations: 50% w/v in Alembicol D
B. CHALLENGE EXPOSURE - TOPICAL APPLICATIONS:
- No. of exposures: 10 animals tested
- Time after induction: The control and test animals were challenged topically two weeks after the topical induction application.
- Day(s) of challenge: 72 hours after removal of the patches
- Exposure period: 24 hours
- Test groups: Treated with approximately 0.4 mL of Simazine a.i., 50% w/v in Alembicol D.
- Control group: 5 control animals were treated in an identical manner to the test animals.
- Site: Hair was removed by clipping and then shaving from an area on the left flank of each guinea pig. A 20 x 20 mm patch of paper was saturated with approximately 0.2 mL of Simazine a.i., 50% w/v in Alembicol D and applied to an anterior site on the flank. Simazine a.i., 25% w/v in Alembicol D was applied in a similar manner to a posterior site. The patches were sealed to the flank for 24 hours under strips of impermeable plastic adhesive tape covered by elastic adhesive bandage wound round the trunk and secured with "Sleek" impervious plastic adhesive tape.
- Concentrations: 50 and 25% w/v in Alembicol D
- Evaluation (hr after challenge): The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches. - Challenge controls:
- The challenge control animals were treated in the same way as the animals treated with the test material.
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde was used periodically to check the sensitivity of the guinea-pig strain.
Results and discussion
- Positive control results:
- The positive control results were valid.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Localised dermal reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in one animal
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in one animal
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Localised dermal reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in four animals
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Dryness and sloughing of the epidermis in four animals
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
CLINICAL SIGNS:
No signs of ill health or toxicity were recorded.
BODYWEIGHT:
Bodyweight increases were recorded for all guinea-pigs over the period of the study.
INDUCTION:
Intradermal injections: Necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Slight irritation was seen in test animals at sites receiving Simazine a.i., 10% w/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D alone.
Topical application: Moderate erythema was observed in test animals following topical application with Simazine a.i. 50% w/v in Alembicol D and slight erythema was seen in the control guinea-pigs.
CHALLENGE:
The reactions seen in nine of the ten test animals were not definitely more marked than those seen in the controls, only isolated localised slight reactions were seen for three animals. The remaining animal gave an inconclusive response.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, Simazine a.i. did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in nine of the ten test animals. The remaining animal gave an inconclusive response.
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