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EC number: 217-617-8 | CAS number: 1912-24-9
- 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:
- from 15 November to 17 December 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- Guideline:
- other: Magnusson B., Kligman A.M. (1970) Allergic Contact Dermatitis in the Guinea pig: Identification of contact allergens, Thomas C.C., Spriengfield, Illinois, U.S.A.
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Atrazine
- EC Number:
- 217-617-8
- EC Name:
- Atrazine
- Cas Number:
- 1912-24-9
- Molecular formula:
- C8H14ClN5
- IUPAC Name:
- 6-chloro-N2-ethyl-N4-(propan-2-yl)-1,3,5-triazine-2,4-diamine
- Details on test material:
- Atrazine technical
Chemical name: 6-chloro-N2-ethyl-N4-isopropyl-1,3,5-triazine-2,4-diamine
Appaerance: white powder
Intended use: herbicide
Batch number: 2489
Purity: 96.9%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- The animals were in the weight range of 296 to 340 g on arrival and approximately four to five weeks of age. All the guinea-pigs were acclimatised to the experimental environment for twelve days prior to allocation to the main study.
The guinea-pigs were housed in groups of 5 in suspended metal cages with wire mesh floors in building R 17 Room 14.
A vitamin C enriched guinea-pigs diet FD2 and drinking water were provided ad libitum. hay was given weekly.
Animal room temperature was maintained at approximately 21°C relative humidity at 30-70%. These environmental parameters were recorded daily. air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hours period.
Each animals was identified by ear tatoo number, each cage was identified by a coloured label .
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alebicol D (a product of coconut oil, supplied by Alembic Products, Saltney, Chester, Englad)
- Concentration / amount:
- Based on the results of the preliminary investigations, the following concentrations of Atrazine a.i.were selected:
Induction intradermal injection: 10% w/v in Alebbicol D
Induction topical application: 50% w/v in Alebbicol D
Topical challenge: 50 and 25% w/v in Alebbicol D
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alebicol D (a product of coconut oil, supplied by Alembic Products, Saltney, Chester, Englad)
- Concentration / amount:
- Based on the results of the preliminary investigations, the following concentrations of Atrazine a.i.were selected:
Induction intradermal injection: 10% w/v in Alebbicol D
Induction topical application: 50% w/v in Alebbicol D
Topical challenge: 50 and 25% w/v in Alebbicol D
- No. of animals per dose:
- 15 healthy male albino guinea-pigs of the Dunkin/hartley strain were obtained from D. Hall, Newchurch, Staffordshire, England.
The animals on the main study were allocated without conscious bias to 2 groups as follows:
Control animals: 5 animals
test animals: 10 animals
An additional six anomals, from the same supplier, were used for the preliminary investigations. - Details on study design:
- The procedure of the main study may be considered in 2 parts, Induction and Challenge.
Induction intradermal injections-test animals
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 x40 mm area within the clipped area
Injectahles for the test animals were prepared as follows:
1.Freunds complete adjuvant was diluted with an equal volume of water for irrigation (Ph. Eur.)
2. Atrazine a. i., 10% w/v in Alembicol D
3. Atrazine a. i., 10% w/v in a 50 : 50 mixture of Freund s complete adjuvant and Alembicol D.
Induction topical application - test animals
The prel minary investigations indicated that the maximum practical concentration of the test substance for topical application (50%) did not produce skin irritation. Therefore, six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pretreated hy gentle rubbing with 0.2 ml per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 x 40 mm patch of Whatman No. 3 paper was saturated with approximately 0.4 ml of Atrazine 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 (50 mm width). This in turn was firmly secured by elastic adhesive bandage (50 mm width) wound round the torso of the animal and fixed with an impervious plastic adhesive tape. The dressing was left in place for 48 hours.
Induction control animals
During the induction phase the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application.
Challenge control and test animals
The control and test animals were challenged topically two weeks after the topical induction application using Atrazine a.i. 50 and 25% w/v in Alembicol D.
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 Whatman No. 3 paper was saturated with approximately 0.2 ml of Atrazine a. i. 50% w/v in Alembicol D and applied to an anterior site on the flank. Atrazine 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 a plastic adhesive tape
covered by an elastic adhesive bandage wonnd round the trunk and secured with an impervious plastic adhesive tape. - Challenge controls:
- see "Details on study design (traditional tests)"
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- The sensitivity of the guinea-pig strain used was checked periodically with hexyl cinnamic aldehyde, a known sensitiser.
Number of test animals: 10
Number of control animals: 5
Dose level (%):
Induction intradermal injection: Atrazine 10% w/v in Alembicol D
Induction topical application: Atrazine 50% w/v in Alembicol D
Challenge: Atrazine 50 and 25% w/v in Alembicol D.
Results:
Firs test:
Positive: 10/10 Inconclusive: 0/10 Negative: 0/10
Second test:
Positive: 9/10 Inconclusive: 0/10 Negative: 0/10
Third test:
Positive: 10/10 Inconclusive: 0/10 Negative: 0/10
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- positive response both for erythema and oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: positive response both for erythema and oedema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- Positive response both for erythema and oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: Positive response both for erythema and oedema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- positive response only for erythema, no oedema formation
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: positive response only for erythema, no oedema formation .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Positive response both for erythema and oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Positive response both for erythema and oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- positive response only for erythema, no oedema formation.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: positive response only for erythema, no oedema formation..
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Positive response both for erythema and oedema.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Positive response both for erythema and oedema..
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- positive response both for erythema and oedema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: positive response both for erythema and oedema.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- positive response only for erythema, no oedema formation.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: positive response only for erythema, no oedema formation..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D, Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D, Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D, Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D, Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D, Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: Anterior site, exposed to atrazine a.i., 50% w/v in Alebicol D, Posterior site, exposed to atrazine a.i., 25% w/v in Alembicol D. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Dermal reactions in the test animals elicited hy the challenge application were compared with the findings simultaneously ohtained i a the control animals.
A test animal was considered to show positive evidence of delayed contact hypersensitivity if the observed dermal reaction at challenge was definitely more marked and/or persistent than the maximum reaction seen in animals of the control group.
If the dermal reaction seen in a test animal at challenge was slightly more marked and/or persistent than (but not clearly distinguishable from) the maximum reaction seen in control animals, the result for that test animal was classified as inconclusive.
A test animal was considered to show no evidence of delayed contact hypersensitivity if the dermal reaction resulting from the challenge application was the same as, or less marked and/or persistent than the maximum reaction seen in animals of the control group.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this study, Atrazine a.i. produced evidence of skin sensitization (delayed contact hypersesitivity) in all ten test animals.
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