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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
abraded skin
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxybis(methyl-2,1-ethanediyl) diacrylate
EC Number:
260-754-3
EC Name:
Oxybis(methyl-2,1-ethanediyl) diacrylate
Cas Number:
57472-68-1
Molecular formula:
C12H18O5
IUPAC Name:
oxydipropane-1,2-diyl bisacrylate
Details on test material:
- Name of test material (as cited in study report): A209415
- Physical state: liquid
- Analytical purity: no data
- Storage condition of test material: room temperature away from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farms
- Age at study initiation: young adults
- Weight at study initiation: 2.75 to 3.10 kg
- Housing: individually housed in stainless steel wire-bottomed cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 26 days


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 240 cm2
- % coverage: 10 %
- Type of wrap if used: the test site was occluded with a layer of 4-ply gauze, two single layers thick. The trunk of the rabbit was wrapped with rubber
latex dental dam and the dental dam, taped at the edges with 1 inch Micropore, tape to form an airtight occlusive wrap.


REMOVAL OF TEST SUBSTANCE
after 24 hours the residual test material was wiped off


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.88 ml/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on the day of dosing and twice daily thereafter, weighing on the day before the study, day 0, day 6 and day 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no deaths
Clinical signs:
other: signs of systemic toxicity were observed on day 1 gradually decreasing in severity and incidence to day 6, when they were no longer present. These signs consisted of the following: eyes appear bluish, ears cool to touch, increased rate of respiration, hun
Gross pathology:
lungs spotted dark red in color in 1/5 female animals, lungs dark red in color in 4/5 male and 1/5 female animals. No significant other pathological
findings.
Other findings:
Evaluation of local skin reactions revealed: erythema (10/10), edema (10/10), hemorrhage (9/10), eschar formation (9/10), fissuring (7/10), scattered raw areas (3/10), scaling (4/10), coriaceous (6/10), abraded lines well defined (2/10) and compound residue present (10/10)

Applicant's summary and conclusion