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EC number: 254-447-3 | CAS number: 39430-51-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 August - 19 August 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- and EU Method B.3 of the directive 92/69/EEC (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel des Produits Chimiques
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Acetic acid, chromium salt, basic
- EC Number:
- 254-447-3
- EC Name:
- Acetic acid, chromium salt, basic
- Cas Number:
- 39430-51-8
- Molecular formula:
- Crx(OH)y(CH3COO)z, where y= 2 - 8, y + z =3x
- IUPAC Name:
- chromium(3+) acetate dihydroxide
- Details on test material:
- - Name of test material (as cited in study report): Chromium (III) acetate
- Substance type: green powder
- Physical state: solid
- Analytical purity: > 95%
- Lot/batch No.: 1000141379
- Expiration date of the lot/batch: 03 July 2009
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 223 - 237 g (males), 205 - 227 g (females)
- Fasting period before study: no
- Housing: during treatment in individual cage (solid-bottomed clear polycarbonate cages with stainless steel mesh lid; sawdust bedding, changed at least two times a week; conventional air condition); at D3 animals were put into cage by 2 or 3
- Water: tap-water from public distribution
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 48 -72
- Air changes (per hr): at least 10 changes
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw test item diluted in distilled water; effective dose of 2000 mg/kg bw
test item - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily, weighing on day 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No deaths occured. No clinical signs.
- Sex:
- male/female
- Dose descriptor:
- other: local NOAEL
- Effect level:
- >= 11 other: mg/cm²
- Remarks on result:
- other: No local effects were observed.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no treatment related changes
Any other information on results incl. tables
Table: clinical observations (N = normal, No = none)
Observations |
Males |
Females |
||||||||
T0 + 1 Hour T0 + 3 Hours T0 + 4 Hours |
Rm |
Rm |
Rm |
Rm |
Rm |
Rf |
Rf |
Rf |
Rf |
Rf |
1087 |
1088 |
1089 |
1090 |
1091 |
1092 |
1093 |
1094 |
1095 |
1096 |
|
Spontaneous activity |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Convulsions |
No |
No |
No |
No |
No |
No |
No |
No |
No |
No |
Tremors |
No |
No |
No |
No |
No |
No |
No |
No |
No |
No |
Body temperature |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Mortality |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
||||||||
Table: clinical observations (N = normal, No = none)
Observations |
Males |
Females |
||||||||
D1 to D14 |
Rm |
Rm |
Rm |
Rm |
Rm |
Rf |
Rf |
Rf |
Rf |
Rf |
1087 |
1088 |
1089 |
1090 |
1091 |
1092 |
1093 |
1094 |
1095 |
1096 |
|
Spontaneous activity |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Convulsions |
No |
No |
No |
No |
No |
No |
No |
No |
No |
No |
Tremors |
No |
No |
No |
No |
No |
No |
No |
No |
No |
No |
Body temperature |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Treatment site |
N* |
N* |
N* |
N* |
N* |
N* |
N* |
N* |
N* |
N* |
Mortality |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
N* = slight green coloration at D1 and D2 |
|||||||||
Table: body weight and weight gain in grams
Males |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rm 1087 |
232 |
238 |
6 |
273 |
41 |
309 |
77 |
Rm 1088 |
230 |
237 |
7 |
276 |
46 |
323 |
93 |
Rm 1089 |
227 |
231 |
4 |
265 |
38 |
306 |
79 |
Rm 1090 |
237 |
245 |
8 |
282 |
45 |
324 |
87 |
Rm 1091 |
223 |
231 |
8 |
261 |
38 |
300 |
77 |
Mean |
229.8 |
236.4 |
6.6 |
271.4 |
41.6 |
312.4 |
82.6 |
Standard deviation |
5.3 |
5.8 |
1.7 |
8.4 |
3.8 |
10.6 |
7.1 |
Females |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rf 1092 |
205 |
220 |
15 |
234 |
29 |
257 |
52 |
Rf 1093 |
208 |
213 |
5 |
224 |
16 |
254 |
46 |
Rf 1094 |
211 |
213 |
2 |
230 |
19 |
242 |
31 |
Rf 1095 |
206 |
212 |
6 |
226 |
20 |
250 |
44 |
Rf 1096 |
227 |
226 |
-1 |
242 |
15 |
255 |
28 |
Mean |
211.4 |
216.8 |
5.4 |
231.2 |
19.8 |
251.6 |
40.2 |
Standard deviation |
9.0 |
6.1 |
6.0 |
7.2 |
5.5 |
5.9 |
10.3 |
Table: necroscopic observations males (X = Euthanasia, at term; N.t.r. = nothing to report)
Observed organs |
Results |
|
Oesophagus |
X |
N.t.r. |
Stomach |
X |
N.t.r. |
Duodenum |
X |
N.t.r. |
Jejunum |
X |
N.t.r. |
Ileon |
X |
N.t.r. |
Caecum |
X |
N.t.r. |
Colon |
X |
N.t.r. |
Rectum |
X |
N.t.r. |
Spleen |
X |
N.t.r. |
Liver |
X |
N.t.r. |
Thymus |
X |
N.t.r. |
Trachea |
X |
N.t.r. |
Lungs |
X |
N.t.r. |
Heart |
X |
N.t.r. |
Kidneys |
X |
N.t.r. |
Urinary Bladder |
X |
N.t.r. |
Testicles |
X |
N.t.r. |
Ovaries |
- |
- |
Uterus |
- |
- |
Treatment Area (Skin) |
X |
N.t.r. |
Adrenals |
X |
N.t.r. |
Pancreas |
X |
N.t.r. |
Particulars: none |
||
Table: necroscopic observations females (X = Euthanasia, at term; N.t.r. = nothing to report)
Observed organs |
Results |
|
Oesophagus |
X |
N.t.r. |
Stomach |
X |
N.t.r. |
Duodenum |
X |
N.t.r. |
Jejunum |
X |
N.t.r. |
Ileon |
X |
N.t.r. |
Caecum |
X |
N.t.r. |
Colon |
X |
N.t.r. |
Rectum |
X |
N.t.r. |
Spleen |
X |
N.t.r. |
Liver |
X |
N.t.r. |
Thymus |
X |
N.t.r. |
Trachea |
X |
N.t.r. |
Lungs |
X |
N.t.r. |
Heart |
X |
N.t.r. |
Kidneys |
X |
N.t.r. |
Urinary Bladder |
X |
N.t.r. |
Testicles |
- |
- |
Ovaries |
X |
N.t.r. |
Uterus |
X |
N.t.r. |
Treatment Area (Skin) |
X |
N.t.r. |
Adrenals |
X |
N.t.r. |
Pancreas |
X |
N.t.r. |
Particulars: none |
||
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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