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EC number: 204-251-9 | CAS number: 118-45-6
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (1981, Guideline number not specified)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Health’s Effects Test Guidelines (Federal Register Vol. 50, No. 188)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- 4-chlorophthalic anhydride
- EC Number:
- 204-251-9
- EC Name:
- 4-chlorophthalic anhydride
- Cas Number:
- 118-45-6
- Molecular formula:
- C8-H3-Cl-O3
- IUPAC Name:
- 5-chloro-1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Male Hartley guinea pigs were received from Buckshire Corporation, Perkasie, PA. They weighed 400.6 to 592.3 g on Test Day 1. They were housed two per cage upon arrival and were individually housed following selection for testing. Polycarbonate cages were used. The animals were acclimated for approximately 4 weeks prior to dosing. Water and feed were provided ad libitum. The temperature and humidity were generally maintained at 68 to 74°F and 57 to 92%, respectively. Room lights were on a 12-hour light/dark cycle.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Once weekly for 3 weeks (group 1)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Two weeks after last induction (group 1)
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Once at the time of challenge (group 2)
- No. of animals per dose:
- 10/Test group (100% 4-CLPA topical)
5/Positive Control group - Details on study design:
- 10/Test group (100% 4-CLPA topical)
5/Positive Control group
Treatment Group 1: 10 animals were exposed once weekly for three weeks; challenge two weeks later to 4-CLPA at 100%.
Treatment Group 2: 10 animals were exposed once at the time of challenge to 4-CLPA at 100%.
Treatment Group 3: 5 animals were exposed once weekly for three weeks; challenge two weeks later to DNCB at 0.05%.
Treatment Group 4: 5 animals were exposed once at the time of challenge to DNCB at 0.05%.
Body weights were recorded on Test Day 1 and on the last day of the study for all groups. Observations for signs of irritation/sensitization were recorded approximately 24 and 48 hours following the challenge treatment according to the method of Ritz and Buehler (1980) as follows:
0 = No reactions
0.5 = Very faint erythema, usually non-confluent
1 = Faint erythema, usually confluent
2 = Moderate erythema
3 = Strong erythema, with or without edema
To facilitate scoring following the challenge dose only, skin sites were depilated with Neet depilatory approximately 2 hours prior to the 24-hour scoring.
Evaluation Criteria:
Incidence and severity indices were calculated for test and control animals following the challenge dose. The incidence index is an expression of the number of animals showing a response of greater than or equal to 1 at 24 or 48 hours, versus the total number of animals in the group. The severity index was determined for the 24- and 48-hour intervals by dividing the sum total of the grades in a given treatment group by the total number of animals in that group. - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB, 0.05% in 90% ethanol)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Group 1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Group 1
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Test Challenge
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Group 2
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Test Challenge
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Group 2
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Group 3
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 2
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Group 3
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Positive Challenge
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Group 4
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Positive Challenge
- Dose level:
- 0.05% DNCB
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Group 4
Any other information on results incl. tables
All animals gained weight over the course of the study. No skin reactions occurred for either the induced or the challenge only test article-treated animals. One animal had white skin discoloration at the 24-hour reading and desquamation at the 48-hour reading. Very faint to moderate erythema was seen in the induced positive control animals at both the 24‑ and 48-hour readings. One animal had slight edema at the 48-hour reading. No reactions were observed in the non-induced positive control challenge animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was determined to be not skin sensitising.
- Executive summary:
Skin sensitisation was determined in a study performed according to an OECD guideline (guideline number not specified) and was in compliance with GLP criteria. In this Buehler test, 40 male Hartley guinea pigs were exposed in four different scenarios, although all under semiocclusive conditions. Group 1 was exposed once weekly for 3 weeks and challenge occurred 2 weeks after the last challenge, all with 100% test substance. Group 2 was exposed only once at the time of challenge with 100% test substance. The exposure scenario for group 3 and 4 were similar to group 1 and 2, respectively, but in these groups experiments were conducted with positive control substance Dinitrochlorobenzene (DNCB, 0.05% in 90% ethanol). Skin reactions were evaluated 24 and 48 hours after patch removal. All animals gained weight over the course of the study. No skin reactions occurred for either the induced or the challenge only test article-treated animals. One animal had white skin discoloration at the 24-hour reading and desquamation at the 48-hour reading. Very faint to moderate erythema was seen in the induced positive control animals at both the 24‑ and 48-hour readings. One animal had slight edema at the 48-hour reading. No reactions were observed in the non-induced positive control challenge animals. Based on these results the test substance is considered not to be skin sensitsing.
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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