Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-402-2 | CAS number: 643-79-8
- 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
Relevant data for skin sensitization potential of the target substance is available. In a dermal sensitization study (OECD 406) with ortho-phthalaldehyde in corn oil, 20 young adult female guinea-pigs of the Dunkin-Hartley strain were tested using the method of Magnusson and Kligman. Combining the results of visual and histopathological examinations, all animals of the test substance group were regarded as sensitised. Based on these results, ortho-phthalaldehyde is a dermal sensitiser and is considered to be classified for 'Category 1A' for skin sensitisation based on CLP criteria. This classification is further supported by the results of an LLNA, in which also a Skin Sens 1A, H317 classification is warranted.
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
- Study period:
- 2000-03-27 to 2000-06-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted: 17th July 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Suitable non-LLNA data was already available from 2000. Therefore, the generation of new LLNA data is not necessary.
- Specific details on test material used for the study:
- - Name used in the test report: o-PHTALALDEHYDE
- Chemical name: 1,2-Benzenedicarboxaldehyde
- Trade name: OPA
- CAS no.: 643-79-8
- Batch no.: FKGP908
- Appearance: Slight yellow sloid with scaly appearance
- Conditions of storage: at room temperature, in the dark
- Date of expiry: December 2000 - Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstrasse 27, D-33178 Borchen
- Females (if applicable) non-pregnant: Yes
- Age at study initiation: ca. 6 weeks al the first application
- Weight at study initiation: 343 g to 423 g at the first application
- Diet (e.g. ad libitum): ad libitum, Altromin Standard Diet No. 3022
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: approx. 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.4
- Humidity (%): 52.1
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 10% (v/v) DMSO
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 0.5 g
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- DMSO
- Remarks:
- 10% (v/v) in corn oil
- Concentration / amount:
- 0.1% (w/v) test substance
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1% (w/w) test substance
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Freund’s complete adjuvant (FCA), 1+1 (v/v) blended with physiological saline
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.5 mL test substance (0.1% w/v)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 g acetone
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 0.1% (w/v) test substance
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL acetone
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 animals for the test substance group
10 animals for the control group. - Details on study design:
- RANGE FINDING TESTS:
- 3 female guinea pigs were pretreated with FCA. 4 different concentrations of the test substance were administered intradermally and 7 days later 4 concentrations (10.0, 5.0, 1.0, 0.1% (v/v)) of the test substance were administered epicutaneously. As no suitable concentration for the epicutanous exposure was found in the first preliminary test, a second one was conducted with 3 other untreated (no FCA) female guinea pigs. The modes of application were the same as in the definitive study. The duration of the epicutaneous exposure was 24 hours. The test substance was dissolved in 10 % (v/v) DMSO in corn oil for the intradermal injections, incorporated in white petrolatum for the first epicutaneous administration and dissolved in acetone for the second epicutaneous administration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction: 24 h, epicutaneous induction: 48 h
- Test groups: 1
- Control group: 1
- Site: approx. 2 x 4 cm in the interscapular region
- Frequency of applications: 1 x intradermal, 1 x epicutaneous
- Concentrations:
Intradermal: cranial: all groups: Freund’s complete adjuvant (FCA), 1+1 (v/v) blended with physiological saline; middle injection row: negative control: 10 % (v/v) DMSO in corn oil; test substance group: test substance, 0.1 %(w/v) in 10 % (v/v) DMSO in corn oil; caudal: negative control group: FCA, 1+1 (v/v) blended with 10 % (v/v) DMSO in corn oil; test substance group: final concentration of the test substance: 0.1 %(w/v) in: 10 % (v/v) DMSO in corn oil, 1 + 1 (v/v) blended with FCA.
Epicutaneous: 1% test substance in white petrolatum
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21 (after intradermal induction exposure)
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: 2 x 2 cm on the left flanks
- Concentrations: 0.1% test substance in acetone
- Evaluation (hr after challenge): 3 hours, 24 hours - Challenge controls:
- Test patches of the same size, soaked with acetone were applied to the right flanks of all animals. Mode of fixation was the same as for the epicutaneous induction exposure.
- Positive control substance(s):
- yes
- Positive control results:
- Very slight to severe erythema and/or oedema in 8/10 animals 24 and/or 48 hours after the challenge exposure. 8/10 animals had a "positive skin reaction".
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- other: 1st and/or 2nd reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% in acetone
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- very slight to severe erythema and/or edema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- In conclusion, in an in vivo skin sensitisation test conducted in accordance to OECD 406 the test material is considered to be a skin sensitiser under UN GHS 'Category 1A'.
- Executive summary:
In an dermal sensitisation study conducted according to OECD 406 with ortho-phthalaldehyde in corn oil, 20 young adult female HsdPoc:DH guinea pigs were tested using the Guinea Pig Maximisation Test of Magnusson and Kligman. Twenty female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. There were two induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure. 19/20 animals of the test substance group had a positive skin reaction at the visual examination 48 hours after challenge exposure. No animal of the control group had a positive skin reaction and the vehicle treated sites of all animals were normal. Histopathologically, 18/20 animals of the test substance group were found to have a positive skin reaction at the test substance treated sites (compared to the vehicle treated site of the same animal) and no positive skin reaction was noted in any control animal. Combining the results of visual and histopathological examinations, all animals of the test substance group were regarded as sensitised. Based on these results, ortho-phthalaldehyde is a dermal sensitiser and is considered to be classified for 'Category 1A' for skin sensitisation based on CLP criteria.
Reference
Table 1: Results of the Challenge exposure
Group |
Number of animals at challenge exposure |
Number of animals with positive reactions |
Net rate of animals with positive skin reactions (%) |
Negative control |
10 |
0 |
- |
Test substance |
20 |
20 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Relevant data for skin sensitisation potential of the target substance is available. In an dermal sensitisation study conducted according to OECD 406 with ortho-phthalaldehyde in corn oil, 20 young adult female HsdPoc:DH guinea pigs were tested using the Guinea Pig Maximisation Test of Magnusson and Kligman. Twenty female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. There were two induction exposures (intradermally and epicutaneously) and one epicutaneous challenge exposure. 19/20 animals of the test substance group had a positive skin reaction at the visual examination 48 hours after challenge exposure. No animal of the control group had a positive skin reaction and the vehicle treated sites of all animals were normal. Histopathologically, 18/20 animals of the test substance group were found to have a positive skin reaction at the test substance treated sites (compared to the vehicle treated site of the same animal) and no positive skin reaction was noted in any control animal. Combining the results of visual and histopathological examinations, all animals of the test substance group were regarded as sensitised. Based on these results, ortho-phthalaldehyde is a dermal sensitiser and is considered to be classified for 'Category 1A' for skin sensitisation based on CLP criteria. This result is supported by a LLNA from Anderson, 2009. In this study, conducted similar to OECD 429 with ortho-phthalaldehyde (>99% purity) dissolved in dimethylformamide, young adult Balb/c female mice (5 per dose group) were tested. No mortality occurred during the study and no clinical toxicity was observed. The EC3 value was calculated to be a test item concentration of 0.089%. The stimulation index was >3 at concentrations of 0.1% and 0.75% compared to the negative control. In this study, the test item is a dermal sensitiser under "Category 1A" according to UN GHS.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a dermal sensitisation study according to OECD 406, female guinea pigs were tested positive for ortho-phthalaldehyde. Based on the results, classification of ortho-phthalaldehyde as Skin Sens 1A, H317 is warranted.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.