Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VIII.
Author:
Carpenter CP et al.
Year:
1974
Bibliographic source:
Toxicol. Appl. Pharmacol. 28: 313-319

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Range-finding toxicity test according to the method described by Smyth HF Jr. et al. (1962).
Smyth HF Jr. et al. (1962). Range-finding toxicity data: List VI. Amer. Ind. Hyg. Ass. J. 23: 95-107
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butane-1,3-diyl diacrylate
EC Number:
243-105-9
EC Name:
Butane-1,3-diyl diacrylate
Cas Number:
19485-03-1
Molecular formula:
C10H14O4
IUPAC Name:
butane-1,3-diyl bisacrylate
Details on test material:
no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: impervious plastic film


REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h




Duration of exposure:
24 h
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Test conditions and method according to Smyth et al. (1962):
Penetration of rabbit skin was estimated by a technique closely akin to  the one-day cuff method of Draize et al. (1944) using groups of four male albino New Zealand rabbits weighing 2.5 to 3.5 kg. The fur was removed from the entire trunk by clipping, and the dose was retained beneath an  impervious plastic film. Dosages greater than 20 mL/kg bw could not be retained in contact with the skin. The animals were immobilized during the 24-hour contact period, after which the film was removed and the rabbits were caged for the subsequent 14-day observation period. The LD50 was calculated by the method of Thompson (1947).

Statistics:
The LD50 was calculated by the method of Thompson (1947).

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
0.45 mL/kg bw
Based on:
test mat.
95% CL:
> 0.21 - < 0.95
Remarks on result:
other: with the density of 1.037, the dermal LD50 is 466 mg/kg bw
Mortality:
yes, no details
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Based on the data, the dermal LD50 of 1,3-butylene glycol diacrylate is 466 mg/kg bw (corresponding to 0.45 ml/kg bw) in rabbits.