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EC number: 605-140-1 | CAS number: 158237-07-1
- 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 February - 21 March 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- other: Dose range finding study for short-term study
Reference
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 16 - 30 January 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Remarks:
- Summary dose range finding study (documentation insufficient for assessment)
- Reason / purpose for cross-reference:
- other: Dose range finding study for short-term study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test:
Dose range finding study (subacute)
- Short description of test conditions: Female rats were treated with the test substance at a dose of 100, 300 or 1000 mg/kg bw/day for a period of 12 days. The test substance was administered dermally for 6h/day and 5 days per week.
- Parameters analysed / observed: clinical symptoms, skin redness, food consumption, body weights, clinical chemistry analysis (cholinesterase inhibition), organ weights and macroscopic analysis - GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 12 days
- Frequency of treatment:
- 5 days per week in the first week, 6h/day
7 days per week in the second week, 6h/day - Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Control animals:
- yes
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
CLINICAL OBSERVATIONS: Yes
DERMAL IRRITATION: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: Yes (cholinesterase inhibition)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (macroscopic analysis, organ weights)
HISTOPATHOLOGY: No - Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- 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 examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: decreased cholinersterase activity ChE activity in erythrocytes (42%), plasma (33%) and brain (9%)
300 mg/kg bw/day: decreased cholinersterase activity ChE activity in erythrocytes (33%), plasma (30%) and brain (2%)
100 mg/kg bw/day: decreased cholinersterase activity ChE activity in erythrocytes (21%), plasma (23%) and brain (2%) - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw: adrenal weights increased
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Based on the results of the conducted dose range finding study, especially the flat dose-response curve in ChE inhibition, doses of 50 - 250 - 1000 mg/kg bw/day were applied in the short-term repeated dose study (please refer to 1997k).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Version / remarks:
- Adopted: 12 May 1991
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
- EC Number:
- 605-140-1
- Cas Number:
- 158237-07-1
- Molecular formula:
- C16H20ClN5O2
- IUPAC Name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdCpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Females: nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks (males), 15 weeks (females)
- Weight at study initiation: 243 to 279 g (males), 217 to 239 g (females)
- Housing: 5 animals (<180g body weight) or 3 animals (>180g body weight) separated by sex in polycarbonate cages type III during adaption period, individally in polycarbonate cages type IIA. Low-dust wood shavings type S 8/15 (Ssniff, Spezialdiaten GmbH, Soest/Westphalia, Germany) were used as litter.
- Diet: Altromin® 1321 meal (Altromin GmbH, Lage), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least seven days
DETAILS OF FOOD AND WATER QUALITY:
The tap water complied with drinking water standards in accordance with the Deutsche Trinkwasserverordnung.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55% ± 5%
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with water
- Details on exposure:
- TEST SITE
- Area of exposure: 5.5 x 5.5 cm = 30.25 cm²
- % coverage: >10% body surface area
- Type of wrap if used: gauze-layer ,,Hansapor steril" patch moistened with water, gauze strip was secured by using ,,Peha-Haft" cohesive stretch tape (8 x 23 cm). Additionally, the mobility of the rats was impaired by a ,,Lomir Biomedical Inc." rat jacket, which was connected in two rats with a safety pin to the stretch tape.
- Time intervals for shavings or clipplings: twice weekly
REMOVAL OF TEST SUBSTANCE
- Washing: cleaned with soap and water
- Time after start of exposure: 6h after exposure
TEST MATERIAL
- Amount(s) applied: 50, 250 and 500 mg/kg bw/day
- Constant volume or concentration used: no
- For solids, paste formed: no, moistened with tap water
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Analytical determinations (stability, homogeneity) were not performed, because the test substance was applied undiluted and only moistened with water immediately before application.
- Duration of treatment / exposure:
- 4 weeks exposure + 2 weeks recovery
- Frequency of treatment:
- 5 days per week for the first three weeks, 6h/day
7 days per week in the fourth week, 6h/day
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 (main study)
5 (recovery period: control and 1000 mg/kg bw/day) - Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: 12 day dose-range finding study (1996d) in female rats. In this study, the doses were 0-100-300-1000 mg/kg. On the application area neither erythema nor oedema of the skin were observed. The administration of 100 and 300 mg/kg showed no toxicologically significant effects. At 1000 mg/kg body weight increased adrenal weights were observed. At all dose levels cholinesterase activity was decreased in erythocytes, plasma and brain.
- Rationale for selecting satellite groups: reversibility of adverse effects
- Post-exposure recovery period in satellite groups: 2 weeks
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice a day, once daily at weekends and public holidays
- Cage side observations checked: body surfaces and orifices, posture, general behavior, breathing and excretory products, including irritation at the dose site, any clinical signs (findings) and abnormalities were recorded
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least twice a day, once daily at weekends and public holidays
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: before start of the study and during the study each day before treatment
BODY WEIGHT: Yes
- Time schedule for examinations: before the study was initiated and at the beginning of each study week
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 28 (main groups) and Day 43 (recovery groups)
- Anaesthetic used for blood collection: Yes (diethyl ether)
- Animals fasted: Yes
- How many animals: all
- Parameters examined: leucocytes (leuco), erythrocytes (ery), hemoglobin (HB), hematocrit (HCT), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), platelet count (thro), hepato-quick (hquick) differential blood count: lymphocytes (lym), polymorphonuclear granulocytes (segm), eosinophils (eos), monocytes (mono), normal red blood cells (norm RBC)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: glucose test - Day 22/23 (main groups) and Day 41 (recovery groups), Day 28 (main groups) and Day 43 (recovery groups)
- Animals fasted: Yes
- How many animals: all
- Parameters examined: aspartat aminotransferase (ASAT), alkaline phosphatase (APh), alanine aminotransferase (ALAT), , glutamate dehydrogenase activities (GLDH), gamma-glutamyl transpeptidase activity (γGT), cholesterol (Chol), triglycerides (trigl), creatinine (crea), urea, bilirubin total (bible-t), protein total (prot), albumin, sodium (Na), potassium (K), calcium (Ca), chloride (Cl), phosphorus (P), glucose, cholinesterase activity in plasma (CHE), cholinesterase activity in erythrocytes (CHE/E) and cholinesterase activity in brain (CHE/B)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Organ weights: adrenal glands, brain, heart, kidneys, liver, lung, spleen, testes, thymus
HISTOPATHOLOGY: Yes (adrenal glands, brain, heart, kidneys, liver, skin (treated and untreated), spleen, testes, thymus, thyroid gland with parathyroid gland, urinary bladder, physical identifier (tattooed ears), one liver lobe and lungs and all organs or tissues with macroscopic findings) - Statistics:
- The quantitative results for individual animals were used to calculate arithmetic group means and standard deviations. The results for the groups that received the test substance were compared with those for the control group and significant differences indicated by "+" for p<0.05 and "++" for p<0.01.
The Dunnett test:body weight, feed consumption and organ weight data (relative organ weights subsequent to logarithmic transformation).
The clinical findings are presented by individual animal findings with information on the time of occurrence in question.
Calculation of means and variances was based in part on the non-rounded original values.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Dermal irritation:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- For details please refer to Tables 1 and 2 in "any other information on results incl. tables".
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- For details please refer to Tables 3 and 4 in "any other information on results incl. tables".
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 250 mg/kg bw/day: decreased MCV in females
1000 mg/kg bw/day: decreased MCV in females; no correlation with the doses administered and with the other sex, and all individual values were within the 2 standard deviation-range of the historical control values
For details please refer to Tables 5 in "any other information on results incl. tables". - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: decreased ChE activity in erythrocytes in both sexes, in brain in females only (reversible), increased protein and albumin levels in males (reversible)
For details please refer to Tables 6 in "any other information on results incl. tables". - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: increased thymus and testes weights at end of treatment period, but values were comparable to the controls of the recovery group (in the recovery group all organ weights were comparable to controls)
For details please refer to Tables 7 in "any other information on results incl. tables". - Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Other effects:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- local
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed up to this dose level
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- Key result
- Dose descriptor:
- LOAEL
- Remarks:
- systemic
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day
- System:
- nervous system
- Organ:
- other: ChE activity inhibited in erythrocytes and brain (statistically significant inhibition by 20% or more in erythrocytes or brain is considered a clear toxicological effect)
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Table 1: Body weight (g) - main groups
dose (mg/kg) |
day 0 |
day 7 |
day 14 |
day 21 |
day 28 |
sex |
0 |
260
|
279 |
299 |
311 |
323 |
male |
50 |
253 |
265 |
283 |
301 |
316 |
male |
250 |
264 |
284 |
303 |
319 |
335 |
male |
1000 |
253 |
278 |
295 |
311 |
321 |
male |
0 |
227 |
227 |
232 |
234 |
237 |
female |
50 |
225 |
224 |
230 |
233 |
236 |
female |
250 |
227 |
224 |
229 |
233 |
232 |
female |
1000 |
228 |
226 |
230 |
231 |
235 |
female |
* statistical evaluation not possible
+ = 5 % significance level
Table 2: Body weight (g) - recovery groups
dose (mg/kg) |
day 0 |
day 7 |
day 14 |
day 21 |
day 28 |
day 35 |
day 42 |
sex |
0 |
259 |
271 |
278 |
290 |
295 |
320 |
319 |
male |
1000 |
261 |
278 |
294 |
305 |
321 |
342 |
339 |
male |
0 |
227 |
229 |
233 |
236 |
241 |
247 |
239 |
female |
1000 |
227 |
227 |
231 |
233 |
242 |
243 |
237 |
female |
+ = 5 % significance level
Table 3: Mean feed intake
Mean feed intake – main groups |
|||||||||
|
day 7 |
day 14 |
day 21 |
day 28 |
day 7 |
day 14 |
day 21 |
day 28 |
|
dose (mg/kg) |
g/animal/day |
g/kg bw/day |
sex |
||||||
0 |
23 |
25 |
24 |
23 |
83 |
84 |
77 |
70 |
male |
50 |
22 |
24* |
24 |
24 |
84 |
84* |
80 |
77 |
male |
250 |
24 |
26 |
26 |
23 |
83 |
86 |
80 |
70 |
male |
1000 |
23 |
25 |
25 |
26 |
83 |
83 |
80 |
81+ |
male |
0 |
17 |
19 |
18 |
19 |
73 |
82 |
77 |
79 |
female |
50 |
17 |
19 |
17 |
18 |
74 |
81 |
75 |
77 |
female |
250 |
18 |
19 |
19 |
19 |
78 |
85 |
80 |
83 |
female |
1000 |
17 |
19 |
18 |
19 |
76 |
84 |
77 |
83 |
female |
* statistical evaluation not possible
+ = 5 % significance level
Table 4: Mean feed intake – recovery groups
Mean feed intake – recovery groups |
|||||||||||||
|
day 7 |
day 14 |
day 21 |
day 28 |
day 35 |
day 42 |
day 7 |
day 14 |
day 21 |
day 28 |
day 35 |
day 42 |
|
dose (mg/kg) |
g/animal/day |
g/kg bw/day |
sex |
||||||||||
0 |
22 |
23 |
23 |
23 |
24 |
23 |
82 |
82 |
79 |
76 |
75 |
73 |
male |
1000 |
24 |
25+ |
25 |
26 |
25 |
23 |
87+ |
86+ |
82 |
81 |
74 |
68 |
male |
0 |
18 |
19 |
19 |
21 |
20 |
17 |
79 |
83 |
82 |
86 |
81 |
72 |
female |
1000 |
18 |
20 |
19 |
21 |
20 |
17 |
81 |
85 |
82 |
85 |
82 |
73 |
female |
+ = 5 % significance level
Table 5: Hematology
dose (mg/kg) |
leuco (109/L) |
ery (1012/L) |
HB (g/L) |
HCT (L/L) |
MCV (fl) |
MCH (pg) |
MCHC (g/L ery) |
thro (109/L) |
hquick sec |
sex |
0 |
7.6 |
8.86 |
148 |
0.473 |
53.3 |
16.7 |
314 |
894 |
31.8 |
male (main group) |
50 |
7.3 |
8.74 |
150 |
0.478 |
54.7 |
17.2 |
314 |
1029 |
30.6 |
male (main group) |
250 |
8.8 |
8.94 |
151 |
0.482 |
54.2 |
17.0 |
314 |
1036 |
31.3 |
male (main group) |
1000 |
7.3 |
8.78 |
149 |
0.473 |
53.8 |
17.0 |
316 |
1070 |
32.3 |
male (main group) |
0 |
6.0 |
8.57 |
146 |
0.490 |
57.1 |
17.0 |
298 |
1015 |
27.2 |
female (main group) |
50 |
5.8 |
8.51 |
145 |
0.466 |
54.8 |
17.0 |
310++ |
842+ |
27.1 |
female (main group) |
250 |
5.9 |
8.54 |
139 |
0.454+ |
53.2++ |
16.3 |
306+ |
892 |
26.8 |
female (main group) |
1000 |
5.4 |
8.44 |
138 |
0.455 |
53.9+ |
16.3 |
303 |
952 |
26.4 |
female (main group) |
0 |
8.3 |
9.14 |
148 |
0.481 |
52.6 |
16.2 |
308 |
1100 |
26.2 |
male (recovery group) |
1000 |
7.1 |
8.90 |
146 |
0.479 |
53.8 |
16.4 |
305 |
920 |
26.1 |
male (recovery group) |
0 |
4.4 |
8.18 |
139 |
0.448 |
54.7 |
17.0 |
311 |
901 |
24.9 |
female (recovery group) |
1000 |
5.5 |
8.35 |
140 |
0.446 |
53.4 |
16.7 |
314 |
910 |
25.2 |
female (recovery group) |
+ = 5 % significance level
++ = 1 % significance level
Table 6: Activity cholinesterase
dose (mg/kg) |
CHE plasma kU/L |
CHE plasma % |
CHE erythrocytes kU/L |
CHE erythrocytes % |
CHE brain kU/L |
CHE brain % |
sex |
0 |
0.41 |
- |
0.83 |
- |
12.00 |
- |
male |
50 |
0.41 |
0 |
0.74 |
-11 |
12.64+ |
+5 |
male |
250 |
0.43 |
+5 |
0.73 |
-12 |
12.36 |
+3 |
male |
1000 |
0.46 |
+12 |
0.62+ |
-25+ |
1165 |
-3 |
male |
0 |
1.95 |
- |
0.63 |
- |
12.09 |
- |
female |
50 |
1.75 |
-10 |
0.65 |
+3 |
11.75 |
-3 |
female |
250 |
1.92 |
-2 |
0.62 |
-2 |
11.42 |
-6 |
female |
1000 |
1.55 |
-21 |
0.41++ |
-35++ |
10.88+ |
-10 |
female |
0 |
0.55 |
- |
1.39 |
- |
12.15 |
- |
male (recovery group) |
1000 |
0.50 |
-10 |
1.02 |
-27 |
11.92 |
-2 |
male (recovery group) |
0 |
1.98 |
- |
1.04 |
- |
11.49 |
- |
female (recovery group) |
1000 |
2.13 |
+8 |
1.10 |
+6 |
11.17 |
-3 |
female (recovery group) |
+ = 5% significance level
++ = 1 % significance level
Table 7: Absolute and relative organ weights
Absolute organ weights (mg) |
|||||||||||
dose (mg/kg) |
body weight (g) |
brain |
adrenals |
heart |
lung |
liver |
spleen |
thymus |
kidneys |
testes |
sex |
0 |
323 |
1843 |
43 |
1062 |
1665 |
12956 |
602 |
367 |
2136 |
3062 |
male (main group) |
50 |
316 |
1699 |
43 |
1042 |
1542 |
12481 |
637 |
401 |
1920 |
3075 |
male (main group) |
250 |
335 |
1706 |
42 |
1035 |
1730 |
12907 |
661 |
437 |
2069 |
3208 |
male (main group) |
1000 |
321 |
1769 |
47 |
1069 |
1713 |
13668 |
633 |
487 |
2191 |
3468+ |
male (main group) |
0 |
237 |
1672 |
64 |
870 |
1399 |
9160 |
521 |
309 |
1543 |
- |
female (main group) |
50 |
236 |
1727 |
64 |
848 |
1293 |
8685 |
504 |
304 |
1558 |
- |
female (main group) |
250 |
232 |
1779 |
67 |
832 |
1225 |
9312 |
449 |
253 |
1494 |
- |
female (main group) |
1000 |
235 |
1753 |
59 |
865 |
1268 |
9245 |
500 |
305 |
1526 |
- |
female (main group) |
0 |
320 |
1788 |
37 |
972 |
1613 |
11918 |
608 |
407 |
2092 |
3346 |
male (recovery group) |
1000 |
342 |
1833 |
41 |
1107 |
1586 |
13340 |
623 |
407 |
2291 |
3315 |
male (recovery group) |
0 |
242 |
1738 |
59 |
941 |
1275 |
8791 |
472 |
334 |
1608 |
- |
female (recovery group) |
1000 |
237 |
1639 |
57 |
877 |
1264 |
8543 |
546 |
356 |
1451 |
- |
female (recovery group) |
Relative organ weights (mg) |
|||||||||||
dose (mg/kg) |
body weight (g) |
brain |
adrenals |
heart |
lung |
liver |
spleen |
thymus |
kidneys |
testes |
sex |
0 |
323 |
579 |
13 |
330 |
519 |
4013 |
188 |
112 |
663 |
960 |
male (main group) |
50 |
316 |
538 |
14 |
329 |
486 |
3944 |
202 |
127 |
607 |
972 |
male (main group) |
250 |
335 |
512 |
13 |
310 |
517 |
3858 |
199 |
131 |
621 |
961 |
male (main group) |
1000 |
321 |
556 |
14 |
332 |
531 |
4250 |
197 |
152+ |
683 |
1085 |
male (main group) |
0 |
237 |
708 |
27 |
368 |
591 |
3871 |
220 |
131 |
653 |
- |
female (main group) |
50 |
236 |
731 |
27 |
359 |
547 |
3676 |
213 |
129 |
660 |
- |
female (main group) |
250 |
232 |
767 |
29 |
358 |
527 |
4005 |
193 |
109 |
644 |
- |
female (main group) |
1000 |
235 |
745 |
25 |
367 |
539 |
3933 |
213 |
130 |
649 |
- |
female (main group) |
0 |
320 |
560 |
12 |
303 |
503 |
3726 |
189 |
126 |
655 |
1046 |
male (recovery group) |
1000 |
242 |
536 |
12 |
323 |
465 |
3894 |
183 |
229 |
670 |
971 |
male (recovery group) |
0 |
242 |
720 |
24 |
389 |
528 |
3636 |
195 |
138 |
666 |
- |
female (recovery group) |
1000 |
237 |
693 |
24 |
369 |
533 |
3594 |
229 |
150 |
612 |
- |
female (recovery group) |
+ = 5 % significance level
Applicant's summary and conclusion
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