Registration Dossier

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only 3 animals / sex used in highest dose
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-butanediyl diacrylate
EC Number:
213-979-6
EC Name:
1,4-butanediyl diacrylate
Cas Number:
1070-70-8
Molecular formula:
C10H14O4
IUPAC Name:
1,4-butanediyl diacrylate
Details on test material:
- Name of test material (as cited in study report): Butandioldiacrylat
- Analytical purity: > 90 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
rats: SPF-breed; supplyling company: WIGA, Sulzfeld
diet: Herlian MRH-concentrated feed; suppyling company: H. Eggersmann, Rinteln/Weser; ad libitum
water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: ~49 cm2
- Type of wrap if used: inert foil; fixed with adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: warm water or water/lutrol mixture; drying using tissue paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration: 50% for concentration 400 mg/kg(in olive oil); for all other concentrations the undeluted test substance was applied.
Duration of exposure:
24 h
Doses:
400, 800, 1250, 2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female (exception was dose group 2000 mg/kg bw: 3 male and 3 female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Weighing: one time at the beginning
- Necropsy of survivors performed: yes
- Fur was removed by shaving 15-24 hours before the beginning of the test. Only animals with healthy und undamaged skin were used for the test .
- Other examinations performed: clinical signs, necropsy
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 400 - < 800 mg/kg bw
Mortality:
see table below
Clinical signs:
Resorptive Symptoms of poisoning: unsteady breathing; apathy; staggering; ruffled fur
local irritation: 24 h following application significant primary irritations can be detected, which turns into necrosis on day 4.
Body weight:
average body weight:
males: 223g
females: 188g
Gross pathology:
animals that died:
heart: acute dilatation (right side); acute congestive hyperemia;
lung: in some cases acute inflation of medium grade
surviving animals:
no abnormality detected

Any other information on results incl. tables

Mortality

 Dose (mg/kg bw)  conc. (%) # animals

 died within

1 h

 died within

24 h

 died within

48 h

 died within

7 d

 died within

14 d

 2000  100  3 male  0/3  0/3  0/3  2/3  2/3
     3 female  0/3  3/3  3/3  3/3  3/3
 1250  100  5 male  0/5  5/5  5/5  5/5  5/5
     5 female  0/5  5/5  5/5  5/5  5/5
 800  100  5 male  0/5  5/5  5/5  5/5  5/5
     5 female  0/5  5/5  5/5  5/5  5/5
 400  50  5 male  0/5  0/5  0/5  0/5  0/5
     5 female  0/5  1/5  1/5  1/5  1/5
               

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria