Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-06-09 - 2011-07-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Magnesium acrylate
EC Number:
227-177-9
EC Name:
Magnesium acrylate
Cas Number:
5698-98-6
Molecular formula:
C3H4O2.1/2Mg
IUPAC Name:
magnesium diacrylate
Test material form:
other: liquid
Details on test material:
Aqueous solution of magnesium acrylate,
pH: 6.6
Color: slightly brownish
Composition: 48.3% magnesium diacrylate
Purity (based on 100%): 99.7%
Production date: 24.05.2011
Expiry date: 24.11.2011
Storage: room temperature, keep away from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 221.6 +- 3.8 (male), 185.5 +- 5.9 g (female)
- Fasting period before study: no
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30-70
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk, 4x4 cm²
- % coverage: approx. 10% of the body surface
- Type of wrap if used: gauze pad (4x5 cm, Brauncel, B. Braun Petzold GmbH)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
animal weight: ca. 220 g, application volume: 0.73 ml = 0.046 ml/cm² = (1.25 g/cm³) 0.058 mg/cm²
- Concentration (if solution): 48.3%
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.25 g/ml
- Concentration (if solution): 48.3%
- Lot/batch no. (if required): 11-Go4072
- Purity: 99.7%
Duration of exposure:
24 hours
Doses:
4141 mg/kg magnesium acrylate solution, 48.3%, density 1.25 g/ml
No. of animals per sex per dose:
5
Control animals:
not required

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 141 mg/kg bw
Based on:
test mat.
Remarks:
48.3 % in water
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No animal died
Clinical signs:
other: Signs of skin irritation were not observed at the site of application.
Gross pathology:
No macroscopic pathological organ alterations were observed at the end of the experiment.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The test item "Magnesium Acrylate Solution" (48.3%) was tolerated by the male and female rats at a dose of 4141 mg/kg body weight equal to 2000 mg/kg body weight Magnesium Acrylate without any symptoms of toxicity. Signs of skin irritation were not observed at the site of application.
Thus, the LD50-value for acute dermal toxicity of Magnesium Acrylate is greater than 2000 mg/kg body weight.
Executive summary:

 The test item “Magnesium Acrylate Solution” is a slightly brownish liquid. It was tested for its acute toxicity following dermal application.

Significant acute dermal toxicity of the test item was not expected. Therefore, the limit - dose of 2000 mg/kg body weight for five male and five female rats of the strain White Wistar was chosen according to the OECD Guideline for the Testing of Chemicals No. 402 “Acute Dermal Toxicity”.

 For the dose calculation the given test item concentration of 48.3 % was taken into consideration, i.e. the animals received a dose of 4141 mg/kg of the provided solution.

 The undiluted test item was applied uniformly over the skin and the test area was bandaged for an exposure time of 24 hours.

 No signs of skin irritation were observed at the site of application. Symptoms of systemic toxicity or unusual findings after application of 2000 mg/kg body weight were not recorded at any time during the study.

 No death occurred. Body weight development of the animals remaines positive 7 days and 14 days post application.

 The necropsy 14 days after dermal application showed no macroscopic visible substance related pathologic findings.

 

Thus, the LD50-value for acute dermal toxicity is higher than 4141 mg/kg for the test item “Magnesium Acrylate Solution” (48.3%) equal to 2000 mg/kg Magnesium Acrylate.