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EC number: 249-854-8 | CAS number: 29797-40-8
- 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
In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was found to be non-sensitising to the skin (Dreist/ Bayer, 1992).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Dichlorotoluene isomers was investigated in male guinea pigs according to the maximization test tested by Magnusson and Kligman for skin sensitizing properties.
The examination was carried out with the following test item concentrations:
Intradermal induction: 5%
Topical induction: 100%
Provocation: 50% and 25%
The test item was formulated in polyethylene glycol 400 - GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT test was conducted in 1992 - at this time point no valid guideline for a LLNA was available
- Species:
- guinea pig
- Strain:
- other: BOR:DHPW
- Sex:
- male
- Route:
- intradermal
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- Intradermal induction: 5%,
Topic induction: 100%,
Challenge: 50% and 25% - Route:
- other: epicutaneous, Fermoflex-Plaster (not defined if occlusive or not)
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- Intradermal induction: 5%,
Topic induction: 100%,
Challenge: 50% and 25% - No. of animals per dose:
- 20 (test substance group); 10(control group).
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 15.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- other: see 'Overall remarks, attachments'.
- Remarks:
- The sensitivity and reliability of studies according Magnusson and Kligman conducted in the testing facility performing the study with dichloromethylbenzene (Institute of Toxicology at the BAYER AG) were evaluated regularly as required by the test guideline. For the respective time period a separate report (Dreist M, BAYER Report n° 21251) is available. This report is available in German language: Dreist, M.: Ueberpruefung der im Fachbereich Toxikologie der BAYER AG angewandten Methodik des Maximierungstests nach Magnusson und Kligman am Meerschweinchenstamm DHPW unter Verwendung von alpha-Hexylzimtaldehyd BAYER-report Nr. 21251 from 1992-04-03.
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was tested in male guinea pigs. The testing was performed with following test substance-concentrations:
Intradermal induction: 5%
Topic induction: 100%
Challenge: 50% and 25%
Polyethylene glycol 400 served as vehicle.
After the first challenge with a 50% test item formulation, 75% of the animals treated with the test item and 80% of the control animals revealed a skin redness. With a 25% formulation of the test item, neither the animals treated with the test item nor the control animals were positive.
The skin reactions found after application of the 50% test item are due to a primary irritating potential of the test item concentration.
The substance is therefore not-sensitising to the skin.
Reference
Numbers of animals exhibiting skin redness (48 and 72 hours after initiation of challange):
test substance group (20 animals) | First control group (10 animals) | |||||||
Test substance patch | Control patch | Test substance patch | Control patch | |||||
Hours | 48 | 72 | 48 | 72 | 48 | 72 | 48 | 72 |
Challenge | ||||||||
50% | 15 | 0 | 0 | 0 | 8 | 0 | 0 | 0 |
25% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
After the first challenge with the 50% test item formulation, 75% of the animals treated with the test item and 80% of the control animals revealed a skin redness. With a 25% formulation of the test item, neither the animals treated with the test item nor the control animals were positive.
The skin reactions found after application of the 50% test item are due to a primary irritating potential of the test item concentration.
Under the conditions of the assay, no evidence of a skin sensitization potential was found for dichlorotoluene isomers.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was tested in male guinea pigs. The testing was performed with following test substance-concentrations:
Intradermal induction: 5%
Topic induction: 100%
Challenge: 50% and 25%
Polyethylene glycol 400 served as vehicle.
After the first provocation with 50% test substance formulation, 75% of the test substance animals and 80% of the control animals showed skin reddening. With 25% test substance formulation neither the test substance animals nor the control animals showed any reactions. The skin reddening after a treatment with the 50% formulation can be evaluated as a primary skin irritating potential of the test substance. No references for a skin sensitising potential can be found. The substance therefore is non-sensitising to the skin (Dreist/ Bayer, 1992).
The sensitivity and reliability of studies according Magnusson and Kligman conducted in the testing facility performing the study with dichloromethylbenzene (Institute of Toxicology at the BAYER AG) were evaluated regularly as required by the test guideline. For the respective time period a separate report (Dreist M, BAYER Report n° 21251) is available. This report is available in German language:
Dreist, M.: Ueberpruefung der im Fachbereich Toxikologie der BAYER AG angewandten Methodik des Maximierungstests nach Magnusson und Kligman am Meerschweinchenstamm DHPW unter Verwendung von alpha-Hexylzimtaldehyd
BAYER-report Nr. 21251 from 1992-04-03.
For the evaluation of the sensitivity and reliability of the test system a complete study (GPMT) according OECD 406 was conducted with alpha-hexyl cinnamaldehyde. Twenty male GP were treated with alpha-hexyl cinnamaldehyde and 20 animals served as control. For the assay the following test item concentrations were used: Intradermal induction: 5%, topical induction: 25% and for challenge: 12% and 3%. Polyethyleneglycol 400 was used as solvent.
After the challenge with 12% alpha-hexyl cinnamaldehyde, 95% of the animals showed a partly slight to moderate skin reddening, and 20% of the control animals showed a partly slight reddening. With a 3% solution of the positive control substance, 20% of the animals revealed partly a slight reddening of the skin, whereas in the control group no skin effects were observed.
Alpha-hexyl cinnamaldehyde reveled under the conditions of the assay a clear skin sensitizing potential. The sensitivity and reliability of the test system is therefore demonstrated.
The GPMT with dichlorotoluene isomere mixture (Dreist M , report n° 21470) was conducted in the time period 1992-03-10 to 1992-04-03 and the sensitivity and reliability test (Dreist M, report n° 21251) for the used GPMT was conducted in the time period 1992-02-18 to 1992-03-13. Therefore the reliability according to OECD GL 406 for a period of 6 months is confirmed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data.
Justification for classification or non-classification
In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was found to be non-sensitising to the skin (Dreist/ Bayer, 1992).
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification for skin sensitisation is not justified.
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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