Acetic acid, chromium salt, basic

Acute Toxicity: oral

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

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. QA statement)

Remarks:

Groupe Interministeriel des Produits Chimiques

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

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.: 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 or test system 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:

other: No clinical signs observed.

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