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EC number: 204-179-8 | CAS number: 117-21-5
- 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:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) 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:
- 3-chlorophthalic anhydride
- EC Number:
- 204-179-8
- EC Name:
- 3-chlorophthalic anhydride
- Cas Number:
- 117-21-5
- Molecular formula:
- C8H3ClO3
- IUPAC Name:
- 4-chloro-1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Male and female Hartley guinea pigs were received from Elm Hill Breeding Labs, Inc. They weighed 365.9-466.8 g and were at least 21 days old. They were group-housed upon arrival in stainless steel suspended cages. The animals were acclimated for at least 5 days prior to dosing. Water and feed were provided ad libitum. The temperature and humidity were maintained at 68+/ 5°F and 30-70%, respectively. Room lights were on a 12-hour light/dark cycle.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- cotton seed oil
- Concentration / amount:
- - Intradermal: 10%; 0.1 mL injected
- Epicutaneous: 100%; 1 g test substance in 2 mL vehicle - Day(s)/duration:
- Intradermal: day 0; Epicutaneous: day 7 with a duration of 48 h
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 100%; 1 g test substance in 2 mL vehicle
- Day(s)/duration:
- Day 21, duration of 24 hours
- No. of animals per dose:
- - Test group: 5/sex
- Negative control group: 2 males & 3 females
- Intradermal irritation: 1 male & 1 female
- Primary topical irritation: 1 male & 1 female - Details on study design:
- A preliminary intradermal irritancy test was conducted, in which 3 CLPA, at concentrations of 100, 50, 10 and 1% in CSO was injected intradermally (0.1 mL/site). It was determined that at 100% and 50% 3 CLPA was severely irritating. At 1% and 10%, 4-CLPA was moderately irritating. In addition, a preliminary topical irritancy test was conducted and 100% 3-CLPA was non-irritating when applied topically. Therefore, 3-CLOX at a concentration of 10% was chosen for the intradermal induction and a concentration of 100% was chosen as the topical induction and challenge doses.
The application sites were prepared by clipping the skin of the test site free of hair. On day 0 and day 7, an approximately 5 x7 cm area over the shoulder region was prepared. On day 21, an approximately 4 x 4 cm square of the flank was prepared.
On Day 0, for the intradermal induction, three pairs of intradermal injections were made so that on either side of the midline there were three injection sites. The dosing solution for each injection is listed below. Injection pairs 1 and 2 were given in close proximity to each other cranially and injection pair 3 was located more caudally. The injection sites were just within the boundaries of 2 x 4 cm.
Test Group
Injection Pair 1: 0.1 mL Freund’s Complete Adjuvant (FCA) 1:1 with CSO
Injection Pair 2: 0.1 mL 3-CLPA at the selected concentration (10% formulation in CSO)
Injection Pair 3: 0.1 mL 3-CLPA 1:1 with FCA
Negative Control Group
Injection Pair 1: 0.1 mL FCA 1:1 with CSO
Injection Pair 2: 0.1 mL CSO (undiluted)
Injection Pair 3: 0.1 mL 50% formulation of CSO 1:1 with FCA
The animals were not treated with sodium lauryl sulfate prior to the topical induction. On Day 7, for the topical induction, the experimental group was dosed with 100% 3-CLPA. 3-CLPA was placed on a 2 x 4 cm piece of filter paper in a thick even layer. The patch was placed on the dorsal surface of the animals, covered by an impermeable sheet, and secured with a non-adhesive bandage which was wound around the torso of the animal. The dressing was left in place for 48 hours. The negative control group was treated in a similar fashion with CSO instead of 3-CLPA.
On Day 21, for the topical challenge, pieces of filter paper measuring 2 x 2 cm were secured ot the flanks for 24 hours, utilizing the same wrapping technique as previously described. For both the test and negative control groups, one patch was placed on the left side with 3-CLPA at 100% and the second patch was placed on the right side with CSO.
Approximately 21 hours after patch removal, the flank skin was cleaned and clipped. Approximately 3 hours later, the first reading of the reactions was performed (Day 23) and the second reading was made on Day 24. For evaluation of skin reactions, the following four-point scale was used:
0 = No reactions
1 = Discrete or patchy erythema
2 = Moderate and confluent erythema
3 = Intense erythema and swelling
Daily observations were made for clinical signs of toxicity. Animals were weighed at the beginning and end of the observation period. - Challenge controls:
- 1 Negative control group: 2 males/3 females
To ensure the sensitivity and reproducibility of the test procedure, positive controls using a well known contact allergen, i.e. DInitrochlorobenzene, are performed regularly at the testing laboratory. - Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
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
- 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
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
Any other information on results incl. tables
All animals gained weight over te course of the study. No systemic signs of toxicity were observed in any animal over the course of the study. None of the test animals exhibited any signs of erythema at any of the challenge observation points. None of the negative control animals exhibited any reaction to the challenge. Moderate to severe erythema and edema was observed at the 100% and 50% concentrations for the Intradermal Primary Irritation animals. There was well defined erythema and edema at 10% and 1% without any overt signs of Systemic toxicity or tissue destruction. The Induction animals were dosed with a 10% dosing solution. No erythema or edema was observed at the 100% concentration for the Topical Primary Irritation animals. The Topical Induction was dosed at 100% concentration. The Topical Challenge was dosed at 100% concentration.
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 OECD 406 and in compliance with GLP criteria. In this study, 5 male and 5 female Hartley guinea pigs were induced intradermal with a 10% solution by a 0.1 mL injection on day 0. On day 7, an epicutaneous induction followed with 100% solution (1 g test substance in 2 mL cotton seed oil), where the test substance was kept under occlusive conditions for 48 hours. On day 21 the animals were challenged by topical application of 100% solution under occlusive conditions for 24 hours. The skin reactions were evaluated 24 and 48 hours after patch removal. Additionally, daily observations were made for clinical signs of toxicity during the test period. Furthermore, animals were weighed at the beginning and end of the observation period. All animals gained weight over the course of the study and no systemic signs of toxicity were observed in any animal over the course of the study. Also, none of the test animals exhibited any signs of erythema at any of the challenge observation points. Based on these results, the test substance is considered to be not skin sensitising.
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