Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 August - 20 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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
and EU Method B.1 tris directive 2004/73/EC (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Remarks:
Groupe Interministeriel des Produits Chimiques
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.: 100014379
- Expiration date of the lot/batch: 03 July 2009
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 189 - 200 g
- Fasting period before study: food was removed one day prior to dosing
- Housing:by groups of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contained sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry
- Water (e.g. ad libitum): tap water from public distribution system
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 42 - 67
- Air changes (per hr): at least ten changes
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg body weight
Doses:
single dose of 2000 mg/kg body weight
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighing at days 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No deaths occured.
Clinical signs:
No clinical signs observed.
Body weight:
Normal throughout study.
Gross pathology:
No treatment related changes.

Any other information on results incl. tables

Table: Clinical observations (N = normal, No = none)

Observations:

Females

T0 + 30 min.

T0 + 1 Hour

T0 + 3 Hours

T0 + 4 Hours

Rf

Rf

Rf

Rf

Rf

Rf

1100

1101

1102

1106

1107

1108

Spontaneous activity

N

N

N

N

N

N

Preyer’s reflex (noise)

N

N

N

N

N

N

Respiratory rate

N

N

N

N

N

N

Convulsions

No

No

No

No

No

No

Tremors

No

No

No

No

No

No

Body temperature

N

N

N

N

N

N

Muscle tone

N

N

N

N

N

N

Palpebral opening

N

N

N

N

N

N

Pupil appearance

N

N

N

N

N

N

Salivation

N

N

N

N

N

N

Lachrymation

N

N

N

N

N

N

Righting reflex

N

N

N

N

N

N

Back hair appearance

N

N

N

N

N

N

Mortality

0

0

0

0

0

0

Remarks

None

None

Table: Clinical observations continued (N = normal, No = none)

Observations:

Females

D1 to D14

Rf

Rf

Rf

Rf

Rf

Rf

1100

1101

1102

1106

1107

1108

Spontaneous activity

N

N

N

N

N

N

Preyer’s reflex (noise)

N

N

N

N

N

N

Respiratory rate

N

N

N

N

N

N

Convulsions

No

No

No

No

No

No

Tremors

No

No

No

No

No

No

Body temperature

N

N

N

N

N

N

Muscle tone

N

N

N

N

N

N

Palpebral opening

N

N

N

N

N

N

Pupil appearance

N

N

N

N

N

N

Salivation

N

N

N

N

N

N

Lachrymation

N

N

N

N

N

N

Righting reflex

N

N

N

N

N

N

Back hair appearance

N

N

N

N

N

N

Mortality

0

0

0

0

0

0

Remarks

None

None

Table: Body weight and weight gain in grams

Females

D0

D2

D2-D0

D7

D7-D0

D14

D14-D0

Rf 1100

189

205

16

225

36

240

51

Rf 1101

193

215

22

236

43

264

71

Rf 1102

195

226

31

228

33

264

69

Rf 1106

190

213

23

213

41

241

51

Rf 1107

200

223

23

243

43

258

58

Rf 1108

198

217

19

231

33

253

55

Mean

194.2

216.5

22.3

232.3

38.2

253.3

59.2

Standard deviation

4.4

7.5

5.0

6.4

4.8

10.8

8.8

Table: necropsy data females Rf1100 - Rf1102 (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.

Ovaries

X

N.t.r.

Uterus

X

N.t.r.

Treatment Area

-

-

Adrenals

X

N.t.r.

Pancreas

X

N.t.r.

Particulars: none

Table: necropsy data females Rf1106 - 1108 (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.

Ovaries

X

N.t.r.

Uterus

X

N.t.r.

Treatment Area

-

-

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