Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-07 to 2009-05-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L173
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: DP/SL 040c/09
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation (administration): males 311 - 360 g, females 208 - 216 g
- Housing: Semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2009-04-07 To: 2009-05-12

Administration / exposure

Type of coverage:
semiocclusive
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: 10
- Type of wrap if used: Gauze dressing and non-irritating tape, fixed with an additional dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: moisted with water "aqua ad injectionem"

VEHICLE
- Lot/batch no. (if required): B. Braun Melsungen, lot. no. 7494A191
- Purity: aqua ad injectionem
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 males, 5 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on day 0, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No findings.
Body weight:
body weight [g] and body weight gain [%]
Animal no. / sex day 0 day 7 day 14 % day 0 - 14
11 F 208 212 222 7
12 F 208 208 218 5
13 F 216 226 241 12
14 F 213 222 240 13
15 F 212 220 233 10
21 M 360 369 409 14
22 M 331 338 372 12
23 M 331 335 395 19
24 M 332 345 373 12
25 M 311 327 353 14

Gross pathology:
No special gross pathological changes

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
After an application period of 24 hours followed by an observation period of 14 days, no mortality and other adverse effects were observed. L173 is non-toxic via the dermal route according to CLP
Executive summary:

The acute dermal toxicity of L173 was assessed in a GLP guideline study according to OECD 402. 2000 mg/kg of the test item were applied on the skin of Wistar rats (5 females, 5 males). The exposure period was 24 h followed by an observation period of 14 days.

No mortalities and no other treatment related other adverse effects were observed.

The substance is considered non-toxic via the dermal route.