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EC number: 200-431-6 | CAS number: 59-50-7
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Sep - 07 Oct 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1998
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF, 59 NohSan No. 4200
- Version / remarks:
- adopted in 1985
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- both sexes are used instead of recommended females, two concentrations in females instead of one starting dose, 6 animals per sex and dose instead of sequential manner with two animals, animals were individually housed instead of group-caging
- GLP compliance:
- yes
- Test type:
- other: acute dermal toxicity
- Limit test:
- no
Test material
- Reference substance name:
- Chlorocresol
- EC Number:
- 200-431-6
- EC Name:
- Chlorocresol
- Cas Number:
- 59-50-7
- Molecular formula:
- C7H7ClO
- IUPAC Name:
- 4-chloro-3-methylphenol
- Test material form:
- solid: pellets
- Details on test material:
- Batch No.: E0136
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Hannover (Crl:Wl(Glx/BRL/Han) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, lnc., Raleigh, NC, USA
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9 weeks (males), approximately 12 weeks (females)
- Weight at study initiation: 230 - 269 g (males), 202 - 227 g (females)
- Housing: individually in suspended stainless steel wire-mesh cages
- Diet: Purina Mills Rodent Lab Chow 5001-4, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and lateral areas of the trunk
- % coverage: a minimum of 10% of the total body surface area
- Type of wrap if used: The test material was held in contact with the skin using a plastic-backed, two-ply gauze patch with hypoallergenic tape. The animal was then wrapped with an elastic bandage, which was also secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed by wiping using paper towels dampened with tap water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 1 mL (males at 5000 mg/kg bw), 0.5 and 1 mL (females at 2000 and 5000 mg/kg bw/day)
- For solids, paste formed: yes - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw (males)
2000 and 5000 mg/kg bw (females) - No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent no treatment
- Remarks:
- control animals received dermal application of deionised water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Detailed observations were conducted at least twice daily (once daily on weekends and holidays). Body weights were measured at the time of treatment (Day 0), and for all surviving animals on Days 7 and 14 following treatment. Terminal body weights were measured for all animals found dead.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Analysis of Variance test followed by the Dunnett's t-statistic where significant differences were detected
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- MALES
5000 mg/kg bw: no mortalities occured
FEMALES
5000 mg/kg bw: 3/6 animals died (at 1 day post-dose)
2000 mg/kg bw: 2/6 animals dies (at 3 days post-dose) - Clinical signs:
- other: MALES 5000 mg/kg bw: ataxia, decreased activity, eye twitching, clear lacrimation and urine staining as signs of systemic toxicity as well as edema, erythema, exfoliation, induration and sloughing as signs of irritation and tissue damage FEMALES 2000 and
- Gross pathology:
- MALES
5000 mg/kg bw:
- animals sacrified at termination: crusty zones and thickened skin at the application sites
FEMALES
2000 and 5000 mg/kg bw:
- animals found dead: lacrimation, urine stained ventrum, discolored urine and discolored treated skin
- animals sacrified at termination: crusty zones and thickened skin at the application sites
Any other information on results incl. tables
Table 1:Results of acute dermal toxicity testing
Dose [mg/kg bw] |
Toxicological results* |
Duration of clinical signs |
Time of death |
Mortality (%) |
Females |
||||
0 |
0/5/6 |
day 0 - day 2 |
--- |
0 |
2000 |
2/6/6 |
day 0 - end |
day 1, day 3 |
33.33 |
5000 |
3/6/6 |
day 0 - end |
day 1 |
50 |
Males |
||||
0 |
0/6/6 |
day 0 - day 1 |
--- |
0 |
5000 |
0/6/6 |
day 0 - end |
--- |
0 |
* number of dead animals/ number of animals with signs of toxicity/ number of animals used
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
- Executive summary:
A study for acute dermal toxicity in the rat was conducted with the test substance according to the OECD Guideline 402 (1987) and in compliance with GLP. Six male and six female Wistar Hanover rats per sex and dose group received a single dermal dose of 0 and 5000 mg/kg bw test substance. 6 additional females received also a dose of 2000 mg/kg bw. The test substance was prepared as a paste using 0.5 mL (for the 2000 mg dose group) and 1 mL (for the 5000 mg dose group) of de-ionised water and applied occlusively to the shaved skin of the animals (a minimum of 10% of body surface). The dressing was removed after 24 h and residual test substance was removed with paper towels moistened with tap water. The animals were inspected at least twice daily during the 14-day observation period (once on weekends and holidays) for mortality, moribundity and clinical signs of toxicity. The animals were weighed individually directly before administration (day 0) and for all surviving animals on day 7 and 14. Terminal body weights were recorded for all animals found dead. A complete gross necropsy was performed on all animals of the study. As a result of dermal application of the test substance, 2/6 females treated with 2000 mg/kg bw died and 3/6 females in the 5000 mg/kg bw group died. No mortalities occurred in male animals. Compound-related clinical signs were observed in all males and females of the treatment groups and included signs indicative of systemic toxicity (ataxia, decreased activity, eye twitching, clear lacrimation, red lacrimation (females), myoclonus (females) and urine staining) as well as tissue damage and irritation at the application sites. A significant decrease in body weight gain was observed for the males of the 5000 mg/kg bw group on day 7 and was considered to be compound-related. Thereafter, body weight gains were in the normal range. Compound-related gross pathological observations were found at necropsy in females found dead before study termination (lacrimation, urine stained ventrum, discolored urine and discolored treated skin) as well as in all surviving males and females at terminal sacrifice (crusty zones and thickened skin at application sites). Under the conditions of this study the LD50 values were considered to be > 5000 mg/kg bw for male rats and > 2000 - < 5000 mg/kg bw in female rats. According to Regulation (EC) No 1272/2008 the test material does not need to be classified for acute dermal toxicity.
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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