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EC number: 935-783-6 | CAS number: -
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP compliant OECD guideline 411 study, tested with the source substance CAS 59-50-7. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-3 (Subchronic Dermal Toxicity 90 Days)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- 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
- Details on test material:
- - Name of test material (as cited in study report): Preventol CMK
- Physical state: Colourless powder
- Purity: 99.96%
- Stability under test conditions: Stability of pure substance and substance in vehicle was confirmed for the study period.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF-bred Wistar rats, (Bor:WISW (SPF Cpb))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 196 - 213 g (males), 165 - 186 g (females)
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Details on exposure:
- TEST SITE
- Area of exposure: About 5 x 5 cm² (left flank)
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, wiping with polyethyleneglycol 400
TEST MATERIAL
- Amount applied: 1 mL/kg bw - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week, 6 h/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20, 100, 500
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10/sex/dose level
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS AND MORTALITY: Yes, twice daily (on weekends and holidays: once daily).
DETAILED CLINICAL OBSERVATION: Yes, once weekly the total body surface, orifices, posture, behaviour, respiration, excrements and all abnormal findings were examined.
BODY WEIGHT: Yes, before treatment, then once weekly and prior to necropsy.
FOOD CONSUMPTION: Yes, before treatment, then once weekly.
WATER CONSUMPTION: Yes, before treatment, then once weekly.
OPHTHALMOSCOPIC EXAMINATION: Yes, on all rats of the control and high dose group. Examinations were performed 3 days before start of treatment and on day 80 in week 12.
HAEMATOLOGY: Yes, all surviving animals in week 5 or 6 and at study termination.
Sampling was done after urine sampling.
Parameters: differential blood count, erythrocyte morphology, erythrocyte count, haemoglobin concentration, haematocrit, leukocyte count, MCH, MCHC, MCV, thromboplastin time, thrombocyte count, reticulocyte count
CLINICAL CHEMISTRY: Yes, all surviving animals in week 5 or 6 and at study termination.
Sampling was done after urine sampling.
Parameters: albumin, glucose, cholesterol, urea, total bilirubin, creatinine, total protein, triglycerides, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), glutamate dehydrogenase (GLDH), P, Cl, Ca,
URINALYSIS: Yes, all animals
Urines were collected in week 5 or 6 and at termination in week 13. Samples were collected over a 16-hour period (over night). No food was provided during this period.
Parameters (semi-quantitative): ketone body, pH value, blood, glucose, bilirubin, protein, urobilinogen, sediment
Parameters (quantitative): total protein, volume, density, protein, creatinine
OTHER: Thickness of skin folds were examined in all animals on treatment days 20 and 60. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all surviving animals were sacrificed at study termination and a gross pathological examination was performed.
ORGAN WEIGHTS: Yes, from all animals sacrificed at termination.
Organs: brain, heart, testis (paired), liver, lung, spleen, kidneys (paired), adrenals (paired).
HISTOPATHOLOGY: Yes, from all animals of the control and highest dose group.
Organs: adrenals, aorta, femur with bone marrow, brain, colon, caecum, duodenum, ileum, jejunum, rectum, duodenum, epididymis, , eyes with nervi optici, femoral muscle heart, kidneys, liver, lungs, lymph nodes, mamma with skin, oesophagus, ovaries, pancreas, pituitary, prostate, salivary glands, seminal vesicles, nervus ischiadicus, skin of back (treated and normal skin), spleen, spinal cord, stomach, sternum with bone marrow, testicles, thymus, thyroid gland, trachea, urinary bladder, uterus, vagina, and all tissues with grossly apparent lesions.
In addition, liver, lungs and kidneys of all animals of the low and mid dose groups. - Statistics:
- Arithmetic group means and standard deviations for bw, food consumption, water-intake, blood and urine analysis and organ weights were determined. The values for the test collective were compared with the control collective by significance test (U-test) using H.B. Mann and D.R. Whitney´s method, or by Wilcoxon´s method on the significance level alpha = 5% and alpha = 1% (two-tailed).
Differences with p-values ≤ 0.01 and ≤ 0.05 were considered statistically significant.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- all dose groups: females showed an unsettled behaviour the first 13 days of treatment. No mortalities occured in any dose group.
- Dermal irritation:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- all dose groups: females showed an unsettled behaviour the first 13 days of treatment. No mortalities occured in any dose group.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- high dose group: Two males and one female had a pale kidney. However, without histopathological correlates.
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: During the first 10 treatment days, all females of all dose groups showed an unsettled behaviour (increased motility with bounding, throwing down, jumping off, running around, biting into cage cover and occlusion). These symptoms decreased from day 11 to 13. From day 14 onwards females behaved like the males. No other signs were noted. No mortalities occurred.
BODY WEIGHT AND WEIGHT GAIN: Body weight gain of all males and females treated with the test substance was comparable to the body weight gain of control animals. The reduced mean body weights of all females of all dose and control groups in week 10 were considered to be not treatment-related.
CLINICAL CHEMISTRY: Males, high dose group: In week 6 the triglyceride values were significant lower compared to control animals. Since the differences were small, only present in one sex and in week 6, this effect was considered to be of no toxicological relevance. In week 13 the protein concentration was significant lower compared to control animals. Since the mean value was within the range of historical controls and only slightly different from control animals, this effect was considered to be of no toxicological relevance.
Males and females of the mid and high dose group:
In week 6, Ca-values of the females, in week 13, Ca-values of males and females were significant lower compared to control animals. This was considered to be not toxicological relevant.
No other effects were found.
GROSS PATHOLOGY: Control group: Two males had smaller testis. This was considered to be of no toxicological relevance.
low dose group: Epididymis of one male showed several yellow areas, which were considered to be of no toxicological relevance.
High dose group: 2 males and one female had a pale kidney.
OTHER FINDINGS: Examination of the skin thickness revealed no significant differences between the control and test substance groups.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment related adverse effects were seen in any dose group.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Results of clinical chemistry, haematology and urinalysis |
|
||||||||
Parameter changed |
Unit |
Weeks after treatment |
Controls |
20 mg/kg bw |
100 mg/kg bw |
500 mg/kg bw |
Dose-response +/– |
||
Males |
|||||||||
Triglycerides |
mmol/L |
6 |
1.04 |
0.90 |
1.09 |
0.76** |
– |
||
13 |
1.00 |
0.96 |
0.96 |
0.88 |
– |
||||
Total protein |
g/L |
6 |
61.8 |
61.3 |
62.5 |
60.9 |
– |
||
13 |
64.7 |
63.2 |
62.1 |
61.7* |
+ |
||||
Calcium |
mM |
6 |
2.65 |
2.67 |
2.46** |
2.46** |
+ |
||
13 |
2.55 |
2.56 |
2.53 |
2.50 |
– |
||||
Females |
|||||||||
Calcium |
mM |
6 |
2.61 |
2.62 |
2.46** |
2.42** |
+ |
||
13 |
2.55 |
2.55 |
2.46** |
2.49* |
– |
||||
*p ≤ 0.05; **p ≤ 0.01 |
|
Table 2: Results of clinical signs and gross pathology |
|||||||||||
Parameter |
Control |
20 mg/kg bw |
100 mg/kg bw |
500 mg/kg bw |
Dose-response +/– |
|
|||||
Males |
Females |
Males |
Females |
Males |
Females |
Males |
Females |
males |
females |
|
|
Number of animals examined |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
|
|
|
Clinical signs |
|
|
|
|
|
|
|
|
– |
– |
|
restlessness |
0/10 |
10/10 |
0/10 |
10/10 |
0/10 |
10/10 |
0/10 |
10/10 |
|
– |
|
Gross pathology |
|
|
|
|
|
|
|
|
|
|
|
smaller testis |
2/10 |
– |
0/10 |
– |
0/10 |
– |
0/10 |
– |
– |
– |
|
yellow areas in epididymis |
0/10 |
– |
1/10 |
– |
0/10 |
– |
0/10 |
– |
– |
– |
|
pale kidney |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
0/10 |
2/10 |
1/10 |
– |
– |
|
anumber of animals affected/total number of animals
Applicant's summary and conclusion
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.