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EC number: 202-462-0 | CAS number: 95-88-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.11 - 25.11. 2003
- Reliability:
- 1 (reliable without restriction)
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations from the minimum level of temperature occurred. Based on laboratory historical data these deviations were considered not to have affected the study integrity.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-chlororesorcinol
- EC Number:
- 202-462-0
- EC Name:
- 4-chlororesorcinol
- Cas Number:
- 95-88-5
- Molecular formula:
- C6H5ClO2
- IUPAC Name:
- 4-chlorobenzene-1,3-diol
- Test material form:
- other:
- Remarks:
- beige powder
- Details on test material:
- Molecular weight: 144.65
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age: at least 6 weeks
Body weight: at least 1.0 kg
Conditions:
Animals were housed in a controlled environrnent, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 I 3.0°C (actual range: 17.9- 21.2°C), a relative humidity of 30-70% (actual range: 41 - 74%) and 12 hours artificial
fluorescent light and 12 hours darkness per day. Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have
affected the study integrity.
Accommodation:
Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56~44~37c.m5 ). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet:
Standard laboratory rabbit diet, approx. 100 g/day.
Water:
Free access to tap-water.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: powdery test substance was moistened with water
- Amount / concentration applied:
- 0.5 g test substance was moistened with 0.6 ml Milli U
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3 males
- Details on study design:
- Approximately 24 hours before treatrnent, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 Square centimeters (10x15 cm2). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the Skin to be treated, which was intact and free frorn abnorrnalities.
Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.6 ml Milli U water and applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
Four hours after the application, the dressing was rernoved and the skin cleaned of residual test substance using water and ethanol.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; bald skin; scaliness
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; scaliness
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; bald skin; scaliness
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; scaliness
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin; scaliness
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: bald skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility; scalliness
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: bald skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; scaliness
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; reduced flexibility of the skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: brown staining of the skin by the test substance; scaliness
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: scaliness
- Irritant / corrosive response data:
- Four hours exposure to 0.5 g of A 012 resulted in very slight, well defined or moderate to severe erythema and slight or moderate oedema in the treated skin-areas of the three rabbits. Reduced flexibility and scaliness of the treated skin were noted among all animals between 72 hours and 14 days after treatment. In addition, the treated skin appeared bald in two animals at 7 or 14 days after treatment. The skin irritation had resolved within 14 days after exposure in one animal, but remained present up to termination in the other animals.
There was no evidence of a corrosive effect on the skin. - Other effects:
- Colouration / Rernnants
Brown staining of the treated skin by the test substance was observed on all animals during the observation period, which did not hamper the scoring of the skin reactions. No remnants of the test substance were present.
Toxicity/ Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Conclusions:
- No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of A 012 to the intact rabbit skin.
Based an these results and according to the:
- OECD Harmonized lntegrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), A 012 should be classified as: mild skin irritant (Class 3).
- EC criteria for classification arid labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), A 012 should be labelled as: irritating to skin (R 38). - Executive summary:
Primary skin irritation/corrosion study with A 012 in the rabbit (4-hour semiocclusive application). The study was carried out based on the guidelines described in: OECD No.404, "Acute Dermal lrritation/Corrosion" (2002); EC Commission Directive 92/69/EEC, 8.4, "Acute Toxicity - Skin irritation" (1992); US EPA, OPPTS 870.2500, Acute Dermal Irritation (1998) and JMAFF, Japanese Test Guidelines (2000).
Three rabbits were exposed to 0.5 grams of A 012 applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours, and 7 and 14 days after exposure. Exposure to A 012 resulted in very slight, well defined or moderate to severe erythema and slight or moderate oedema in the treated skin-areas of the rabbits. Reduced flexibility and scaliness of the treated skin were noted among all animals between 72 hours and 14 days after treatment. In addition, the treated skin appeared bald in two animals at 7 or 14 days after treatment. The skin irritation had resolved within 14 days after exposure in one animal, but remained present up to termination in the other animals.
Brown staining of the treated skin by the test substance was observed on all animals during the observation period, which did not hamper the scoring of the skin reactions. No evidence of full thickness destruction of the skin or scar tissue was observed during the observation period, indicating that no corrosion of the skin had occurred by dermal application of A 012 to the intact rabbit skin.
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