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EC number: 204-617-8 | CAS number: 123-31-9
- 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: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from August 1982 to August 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study comparable to guideline study with acceptable restrictions: only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicity and carcinogenicity of hydroquinone in F344/N rats and B6C3F1 mice.
- Author:
- Kari FW, Bucher J, Eustis SL, Haseman JK, Huff JE
- Year:
- 1 992
- Bibliographic source:
- Food Chem Toxicol 30, 737 - 747
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- (only 2 instead of 3 dose groups, no data on food consumption; hematology and clinical chemistry examinations only at 15 mo, no urinalysis data)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hydroquinone
- EC Number:
- 204-617-8
- EC Name:
- Hydroquinone
- Cas Number:
- 123-31-9
- Molecular formula:
- C6H6O2
- IUPAC Name:
- hydroquinone
- Details on test material:
- - Name of test material (as cited in study report): hydroquinone
- Physical state: colourless, crystalline solid
- Analytical purity: > 99%
- Purity test date:
- Lot/batch No.: 56978
- Stability under test conditions: 2 weeks when stored in the dark at temperatures of up to 60 °C
- Storage condition of test material: bulk material was stored at 25 °C under nitrogen or argon and periodic characterization by infrared or ultravioloet spectroscopy and oxidative titration indicated no deterioration over the course of the studies
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, NY, USA
- Age at study initiation: males 8-9 w , females 9-10 w
- Fasting period before study: no
- Housing: 5 per cage
- Diet: NIH 07 rat ration (Zeigler Bros. Inc., Gardner, PA, USA) ad libitum
- Water: tap water ad libitum
- Acclimation period: males 18 d, females 26 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 27 °C (65 - 80 °F)
- Humidity (%): 40 - 79
- Air changes (per hr): 6 - 13 room air changes per hr
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: appropriate amount of hydroquinone dissolved in deionised water by stirring with a magnetic stir bar; maximum storage time 21 d at room temperature in the dark in amber serum vials with Teflon-lined seals, sparged with argon or nitrogen before sealing
VEHICLE
- Concentration in vehicle: 5, 10 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- UV spectroscopy of acetonitrile extracts at 295 nm or methanol extracts at 293 nm; analyzed concentrations (data from 10 samples each): mean 4.88, range 4.72 - 5.09 mg/mL; mean 9.78, range 9.39 – 10.25 mg/mL; variation considered to be in acceptable range; stability investigations by HPLC after 21 days of storage of the dosing solution at room temperature in the dark indicated no notable decrease of hydroquinone concentration
- Duration of treatment / exposure:
- 65 or 103 w , sacrifice after ca. 65 and 104 to 105 w
- Frequency of treatment:
- 5 d/w
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 100 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 64 or 65 males, 65 females (including 10 for 65 w treatment)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on 13 week range-finding toxicity study (see separate endpoint study record)
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: 2 times per day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 2 times per day
BODY WEIGHT: Yes
- Time schedule for examinations: at initiation of dosing, weekly thereafter for 13 weeks, and monthly for the rest of the study period
FOOD CONSUMPTION: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes, at 15 mo
Investigated parameters: leukocytes, lymphocytes, segmented neutrophiles, monocytes, eosinophils, atypical lymphocytes, atypical mononuclear cells, bands, hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean cell volume, erythrocytes, reticulocytes
CLINICAL CHEMISTRY: Yes, at 15 mo
Investigated parameters: albumin, alkaline phosphatase, alanine aminotransferase, blood urea nitrogen, creatinine, sorbitol dehydrogenase, total protein
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all animals
ORGAN WEIGHTS: Yes, at 15 mo and 2 y
HISTOPATHOLOGY: Yes
Tissues examined in high-dose mice and controls: adrenal glands, brain, caecum, colon, duodenum, epididymis/prostrate/testes or ovaries/uterus, esophagus, gallbladder, gross lesions and tissue masses, heart, ileum, jejunum, kidneys, liver, lungs and mainstem bronchi, mammary gland, mandibular or mesenteric lymph nodes, nasal cavity and turbinates, pancreas, parathyroid glands, pituitary gland, rectum, salivary glands, skin, spleen, sternebrae and vertebrae including marrow, stomach, thymus, thyroid gland, trachea, and urinary bladder
Tissues examined in low-dose male mice: adrenal glands, gross lesions, liver, spleen, thyroid gland
Tissues examined in low-dose female mice: gross lesions, liver, lungs, ovaries, salivary glands, thyroid gland - Statistics:
- Survival probabilities estimated by product-limit procedure of Kaplan and Meier (1958), statistical analysis by methods of Cox (1972) and Tarone (1975);
Statistical significance of organ weights, hematological and clinical chemistry data analyzed by Dunn's test (Dunn, 1964) or Shirley's test (Shirley, 1977);
Data on tumor incidences analyzed by life-table analysis, logistic regression, Fisher's exact test, and Cochran-Armitage trend test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- changes not biologically relevant
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- changes not biologically relevant
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- see discussion in Section 7.7
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No significant differences in survival were observed between any groups of either sex; no compound-related clinical signs
BODY WEIGHT AND WEIGHT GAIN (for details see Table 1)
100 mg/kg: mean body weights of male mice 5-8% lower between week 93 and 104; mean body weight of female mice 5-8% lower between week 20 to 44 and 10-14% lower between week 45 and 104
Evaluation: In females, the decrease of body weight of 10-14% between week 45 and 104 was considered to represent an adverse treatment-related effect.
HAEMATOLOGY (data from 15 mo interim sacrifice group, for details see Table 2)
100 mg/kg: male mice showed significant increases of hematocrit and erythrocytes of 13% compared to the vehicle control
Evaluation: Slight significant increases of hematocrit and erythrocytes were only found in high-dose males and are therefore considered to be of negligible biological significance.
CLINICAL CHEMISTRY (data from 15 mo interim sacrifice group, for details see Table 2)
100 mg/kg: male mice showed showed significant increases of total protein and serum albumin, of serum alkaline phosphatase and of sorbitol dehydrogenase; female mice showed significant increases of total protein and serum albumin, whereas a significantly lower activity was observed for alanine aminotransferase and sorbitol dehydrogenase
Evaluation: The statistically significant effects in general represented only slight changes. Changes in enzyme activites were contrary in both sexes. Therefore the observed changes of clinical chemistry are considered to be of negligible biological significance.
ORGAN WEIGHTS (data from 15 mo interim and terminal sacrifice group, for details see Table 1)
100 mg/kg: relative liver weights of both sexes showed significant increases after 65 and 103 w of administration, whereas relative brain and kidney weights of females showed significant increases only at interim sacrifice after 65 w
50 mg/kg: relative liver weight of males showed a significant increase after 103 w, relative kidney weight of females showed a significant increase after 65 w only
Evaluation: Increases of relative liver weights in both sexes at both doses correlated with histopathological non-neoplastic and neoplastic liver changes (see below). However, increases of relative weights of brains and kidneys in female mice were only observed at the interim but not at the terminal sacrifice and are therefore considered to be of negligible biological significance.
HISTOPATHOLOGY: NON-NEOPLASTIC (for details see Table 3)
LIVER 65-week interim sacrifice:
50 and 100 mg/kg, male mice: increased incidences of diffuse centrilobular fatty change, diffuse cytomegaly, occasional syncytial cells (multinucleated hepatocytes)
LIVER 105-week sacrifice:
100 mg/kg, male mice: increased incidence of anisokaryosis (variation in size of hepatocyte nuclei), syncitial alteration (hepatocytes with more than 5 nuclei per cell), and foci of cellular alteration (basophilic foci) compared to vehicle controls
Evaluation: Centrilobular fatty change and cytomegaly were observed at the 65-week interim sacrifice but not at the terminal sacrifice. This may be explained by the fact that after the 65-week administration necropsy occurred within 24 hrs after the last dose, whereas dosing was stopped 2 weeks before necropsy in the 2 year study. Presumably, fatty change and cytomegaly were reversible after cessation of hydroquinone administration and are considered not to represent a toxicologically relevant effect.
HISTOPATHOLOGY: NEOPLASTIC
For detailed evaluation see Section 7.7
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Remarks:
- chronic non-neoplastic and neoplastic effects
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: liver: increase of weights, histopathologal findings (at 65-week interim sacrifice only)
- Dose descriptor:
- LOAEL
- Remarks:
- chronic non-neoplastic and neoplastic effects
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Significant increase of liver adenoma or carcinoma combined
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Body weights and relative organ weights after 65 and 103 w of gavage (mean ± standard error)
Application period |
Parameter |
Dose groups males |
Dose groups females |
||||
Vehicle control |
50 mg/kg |
100 mg/kg |
Vehicle control |
50 mg/kg |
100 mg/kg |
||
65 w |
Body weight (g) |
45.6±1.26 |
44.9±1.34 |
46.9±1.01 |
46.7±2.51 |
42.4±2.54 |
40.6±1.17 |
Brain * |
10.6±0.41 |
11.0±0.33 |
10.2±0.21 |
10.7±0.48 |
12.2±0.74 |
12.6±0.35a |
|
Kidney * |
18.0±0.63 |
19.6±0.41 |
19.2±0.57 |
11.2±0.30 |
13.1±0.44b |
13.3±0.26b |
|
Liver * |
44.6±2.32 |
52.5±5.35 |
54.8±3.88b |
40.5±0.95 |
40.9±1.15 |
45.2±1.25b |
|
103 w |
Number of animals weighed |
33 |
36 |
36 |
37 |
39 |
36 |
Body weight |
44.0±0.76 |
43.0±0.72 |
42.0 ±0.95 |
50.7±1.65 |
51.5±1.46 |
47.8±1.24 |
|
Brain * |
11.7±0.21 |
11.9±0.22 |
12.1±0.28 |
10.7±0.40 |
10.5±0.38 |
11.0±0.29 |
|
Kidney * |
11.8±0.38 |
11.7±0.23§ |
12.4±0.32 |
7.5±0.44# |
7.4±0.31 |
7.3±0.22 |
|
Liver * |
67.2±4.80 |
76.4±4.82a§ |
70.0±3.17a |
52.0±3.22# |
52.0±2.65 |
55.1±2.68a |
* relative organ weights as mg of organ per g body weight; § N=35 mice weighed; # N=36 mice weighed
Statistically significant increased compared to vehicle control: a p<0.05
Table 2: Overview of statistically significant haematological and clinical chemical parameters in the 65-week gavage studies of hydroquinone
Affected sex |
Endpoint |
Parameter |
Dose group |
||
Vehicle control |
50 mg/kg |
100 mg/kg |
|||
Male |
Hematology |
Hematocrit (%) |
36.5±2.38 |
39.5±1.27 |
41.3±1.17a |
Erythrocytes (106/µL) |
7.3±0.52 |
8.0±0.29 |
8.3±0.28a |
||
Clinical chemistry |
Total protein (g/dL) |
5.2±0.04 |
5.4±0.15 |
5.9±0.23b |
|
Albumin (g/dL) |
3.3±0.05 |
3.5±0.08 |
3.8±0.15b |
||
Alkaline phosphatase (IU/L) |
38.4±2.34 |
38.8±1.41 |
50.0±3.92a |
||
Sorbitol dehydrogenase (SU/mL) |
35.8±1.24 |
35.6±2.05 |
43.0±1.79b |
||
Female |
Clinical chemistry |
Total protein (g/dL) |
5.3±0.07 |
5.5±0.12 |
5.7±0.05b |
Albumin (g/dL) |
3.5±0.06 |
3.6±0.10 |
3.9±0.04b |
||
Alanine aminotransferase (IU/L) |
38.9±6.62 |
31.6±6.19 |
23.7±1.33b |
||
Sorbitol dehydrogenase (SU/mL) |
35.6±1.09 |
33.7±1.37 |
32.4±0.73a |
statistically different from vehicle control: a p<0.05, b p<0.0.1
Table 3: Number of mice with selected lesions in the liver and thyroid gland in the 65 w and 103 w gavage study of hydroquinone
Application period |
Site of lesion |
Type of lesion |
Dose groups males |
Dose groups females |
||||
Vehicle control |
50 mg/kg |
100 mg/kg |
Vehicle control |
50 mg/kg |
100 mg/kg |
|||
65 w |
Number of animals examined |
10 |
10 |
10 |
10 |
10 |
10 |
|
Liver |
Diffuse centrilobular fatty change |
1 |
0 |
7 |
0 |
0 |
0 |
|
Diffuse fatty change |
0 |
0 |
0 |
1 |
3 |
0 |
||
Diffuse cytomegaly |
0 |
8 |
10 |
0 |
0 |
0 |
||
Syncytial cells |
1 |
1 |
4 |
0 |
0 |
0 |
||
Basophilic focus |
0 |
0 |
1 |
0 |
0 |
0 |
||
Clear cell focus |
0 |
0 |
0 |
0 |
0 |
1 |
||
Hepatocellular adenoma |
1 |
1 |
4 |
0 |
1 |
0 |
||
Hepatocellular carcinoma |
2 |
1 |
1 |
0 |
0 |
0 |
||
Hepatocellular adenoma or carcinoma |
3 |
2 |
4 |
0 |
1 |
0 |
||
Thyroid gland |
Hyperplasia |
0 |
0 |
0 |
0 |
0 |
2 |
|
103 w |
Liver |
Number of animals examined |
55 |
54 |
55 |
55 |
55 |
55 |
Anisokaryosis |
0/55 (0%) |
2/54 (4%) |
12/55 (22%) |
n.s. |
n.s. |
n.s. |
||
Syncytial alteration |
5/55 (9%) |
3/54 (6%) |
25/55 (45%) |
n.s. |
n.s. |
n.s. |
||
Basophilic focus |
2/55 (4%) |
5/54 (9%) |
11/55 (20%) |
2/55 (4%) |
6/55 (11%) |
3/55 (5%) |
||
Hepatocellular adenoma |
9/55 (16%) |
21/54 (39%) |
20/55 (36%) |
2/55 (4%) |
15/55 (27%) |
12/55 (22%) |
||
Hepatocellular carcinoma |
13/55 (24%) |
11/54 (20%) |
7/55 (13%) |
1/55 (2%) |
2/55 (4%) |
2/55 (4%) |
||
Hepatocellular adenoma or carcinoma a |
20/55 (36%) |
29/54 (54%) |
25/55 (45%) |
3/55 (5%) |
16/55 (29%) |
13/55 (24%) |
||
Thyroid gland |
Number of animals examined |
55 |
53 |
54 |
55 |
55 |
55 |
|
Hyperplasia |
5/55 (9%) |
15/53 (28%) |
19/54 (35%) |
13/55 (24%) |
47/55 (85%) |
45/55 (82%) |
||
Adenoma |
2/55 (4%) |
1/53 (2%) |
2/54 (4%) |
3/55 (5%) |
5/55 (9%) |
6/55 (11%) |
||
Carcinoma |
0/55 (0%) |
0/53 (0%) |
0/54 (0%) |
0/55 (0%) |
0/55 (0%) |
1/55 (2%) |
||
Adenoma or carcinoma b |
2/55 (4%) |
1/53 (2%) |
2/54 (4%) |
3/55 (5%) |
5/55 (9%) |
7/55 (13%) |
Historical incidences in control groups (means±SD):
a male mice: water vehicle controls: 106/347 (31±6 %), range 20 to 38%; untreated controls 609/2,032 (30±8%), range 16 to 58%
female mice: water vehicle controls: 29/348 (8±5 %), range 0 to 14%; untreated controls 184/2,032 (9±5%), range 2 to 20 %
b female mice: water vehicle controls 10/337 (3±2%), range 0 to 6 %; untreated controls 49/1,937 (3±3%), range 0 to 15%
Applicant's summary and conclusion
- Conclusions:
- The LOAEL for chronic toxicity was 50 mg/kg bw/d both in male B6C3F1 mice based on liver weight effects and liver histopathology at the 65-week interim sacrifice, and in female mice based on increased incidences of hepatocellular adenomas and of hepatocellular adenomas or carcinomas combined (detailed evaluation of neoplastic histopathology in Section 7.7). Female mice showed non-neoplastic findings (decrease of body weights) at 100 mg/kg bw/d only.
- Executive summary:
HQ was administered to groups of 65 male and 65 female B6C3F1 mice for 103 weeks on 5 days per week via gavage at doses of 0, 50, and 100 mg/kg bw/d (vehicle water). The study protocol was similar to OECD Guideline 453 with several minor deviations. There were only 2 instead of 3 dose groups, and food consumption and urinalysis were not examined. Hematology and clinical chemistry examinations were performed at a single timepoint after 65 w of dosing in subgroups of 10 mice of each sex and dose. Mice were sacrificed for gross and histopathological examination at about 66 and 104 to 105 w after start of dosing.
There were no significant differences in survival between any groups of either sex and no compound-related clinical signs. There were no biologically significant changes of haematological or clinical chemistry parameters. Toxicity was indicated at 100 mg/kg by decreased body weights in males (5-8% lower than those of vehicle controls between weeks 93-104), and in females (5-8% lower between week 20-44, 10-14% lower between week 45-104). Relative brain weights (at 100 mg/kg) and kidney weights (at 50 and 100 mg/kg) showed significant increases in female mice at the interim sacrifice only and were considered to be of negligible biological significance. Significant increases of relative liver weights were found at 100 mg/kg in both sexes after 65 and 103 w of administration, and at 50 mg/kg in males after 103 w. Centrilobular fatty change and cytomegaly were observed in male mice at the 65-week interim sacrifice but not at the terminal sacrifice. This may be explained by the fact that after the 65-week administration necropsy occurred within 24 hrs after the last dose, whereas dosing was stopped 2 weeks before necropsy in the 2 year study. Presumably, fatty change and cytomegaly were reversible after cessation of hydroquinone administration. Findings in livers of male mice at 100 mg/kg after 105 w were characterized by increased incidences of anisokaryosis (variation in size of hepatocyte nuclei), syncitial alteration (hepatocytes with more than 5 nuclei per cell), and foci of cellular alteration (basophilic foci) compared to incidences in vehicle controls. Female mice showed increased incidences of hepatocellular adenomas and of hepatocellular adenomas or carcinomas (combined) at 50 and 100 mg/kg bw/d (for detailed presentation and discussion of neoplastic findings see Section 7.7).
The LOAEL for chronic toxicity was 50 mg/kg bw/d both in male B6C3F1 mice based on liver weight effects and liver histopathology at the 65-week interim sacrifice, and in female mice based on increased incidences of hepatocellular adenomas and of hepatocellular adenomas or carcinomas combined. Female mice showed non-neoplastic findings (decrease of body weights) at 100 mg/kg bw/d only.
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