Registration Dossier

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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
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. certificate)
Remarks:
Groupe Interministeriel des Produits Chimiques
Test type:
standard acute 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.: 1000141379
- Expiration date of the lot/batch: 03 July 2009
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
none
Body weight:
normal throughout the study
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