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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1998-03-12 to 1998-05-06
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
92/69/EEC
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-180-1
EC Name:
-
Cas Number:
66170-10-3
Molecular formula:
C6 H9 O9 P . 3 Na (CAS) C6 H6 Na3 P O9 (Hill)
IUPAC Name:
trisodium mono-(5-(1,2-dihydroxyethyl)-4-oxido-2-oxo-2,5-dihydro-furan-3-yl)phosphate
Details on test material:
- Name of test material (as cited in study report): Sodium ascorbyl phosphate
- Physical state: Solid (powder), beige
- Analytical purity: 85.4 g/100 g
- Lot/batch No.: 28600/37-9
- Date of Manufacturing: 1997-05-02
- Storage condition of test material: Room temperature
- Stability under test conditions: The stability of the test substance in aqua bidest. for a time period of 96 hours was confirmed by analysis

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: Animals of comparable weight (200g -300g); +/- 20% of the mean weight
- Housing: single housing, Stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, Germany); No bedding in the cages; wood shavings in the waste trays.
- Diet (e.g. ad libitum): Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland, ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum per day.
- Acclimation period: Acclimatization for at least 1 week.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs (6.00 a.m. - 6.00 p.m./ 6.00 p.m. - 6.00 a.m.)


IN-LIFE DATES: From: 1998-03-12 To: 1998-03-26

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: About 50 cm2 (corresponds to at least 10 % of the body surface area).
- Type of wrap if used: the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG


REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water.
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.22 mL/kg bw,
- Concentration (if solution): 90 g / 100 mL
- Constant volume or concentration used: yes (only one test group, limit test)
- For solids, paste formed: no (suspension applied to skin)


VEHICLE
- Amount(s) applied (volume or weight with unit): 2.22 mL/kg bw
- Concentration (suspension): 90g /100 mL
- Purity: aqua bidest.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semiocclusive dressing (day 1), weekly thereafter and at the end of the study (last day of the observation period). A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with grosspathology examination. Necropsy of all animals that died before as early as possible.
Statistics:
The binomial test (Snedecor G.W., Cochran W.G. (1989), Statistical methods, 8th ed., Iowa State University Press Ames) was used for LD50 determination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: 1 % significance level
Mortality:
No mortality observed after 14 days.
Clinical signs:
Male:
No abnormality.
Local effects: very slight erythema on day 1 (2 of 5 animals).

Female:
No abnormality.
Local effects: very slight erythema on day 1 (2 of 5 animals).
Body weight:
Mean body weight of the male animals:
Before application (day 0): 275 g
after application (day 7): 311 g
after application (day 13): 336 g

Mean body weight of the female animals:
Before application (day 0): 242 g
after application (day 7): 249 g
after application (day 13): 258 g
Gross pathology:
No particular findings.
Other findings:
No other findings.

Applicant's summary and conclusion