Registration Dossier

Administrative data

Description of key information

Based on the available data, the registered substance is considered to be toxic if skin contact and may be harmful by oral route.

No data is available by inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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
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
Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: no


Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
The dosages were arranged in a logarithmic series differing by a factor of two.
No. of animals per sex per dose:
6 males
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):
Single oral dose toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, or in rare instances of female rats, four to five weeks of age and 90 to 120 grams. The dosages were arranged in a logarithmic series differing by a factor of two. Whenever possible, the chemical was administered undiluted. When a lesser concentration was necessary, solution in water or corn oil or suspension in semi-solid agar were the preferred expedients. Occasionally, a 1 % solution of Tergitol penetrant 7 (essentially an aqueous solution of 25 % sodium 3,9-diethyl-6-tridecanol sulfate) has been used as a dispersing agent. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson (1947).

Statistics:
The most probable LD50 value and its fiducial range were estimated by the method of Thompson (1947).

Thompson WR (1947). Use of Moving Averages and Interpolation to Estimate  Median Effective Dose. Bacteriol. Rev. 11: 115
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3.45 mL/kg bw
Based on:
test mat.
95% CL:
> 2.57 - < 4.87
Remarks on result:
other: with a density of 1.037, the LD50 is 3577 mg/kg bw
Mortality:
yes, no details
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the results, the oral LD50 of 1,3-butylene glycol diacrylate is 3577 mg/kg (corresponding to 3.45 ml/kg bw) in rats.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 577 mg/kg bw
Quality of whole database:
The study of carpenter is considered to be reliable.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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).
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
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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
466 mg/kg bw
Quality of whole database:
The study of carpenter is considered to be reliable.

Additional information

The Carpenter's publication (1974) summarizes the results of the acute toxicity studies performed by oral and dermal routes on butane-1.3-diyl diacrylate.

Based on the results, the oral LD50 of 1,3-butylene glycol diacrylate is 3577 mg/kg (corresponding to 3.45 ml/kg bw) in rats, and the dermal LD50 of 1,3-butylene glycol diacrylate is 466 mg/kg bw (corresponding to 0.45 ml/kg bw) in rabbits.

Justification for classification or non-classification

Oral acute toxicity

Based on the available data (oral LD50 of 3577 mg/kg), absence of mandatory classification of Butane-1,3-diyl diacrylate for this endpoint and the composition of the registered substance (containing 65 -100 % of Butane-1,3-diyl diacrylate), no classification of the registered substance is required for oral acute toxicity.

Dermal acute toxicity

Butane-1,3-diyl diacrylate (CAS number 19485 -03 -1) has a mandatory classification according to the Regulation EC 1272/2008 (Annex VI, index number: 607-118-00-7): Acute tox. 4* by dermal route (H312).

The available data showed a dermal LD50 of 466 mg/kg, corresponding to the category 3 of CLP.

Based on the available data (dermal LD50 of 466 mg/kg), the mandatory classification of Butane-1,3-diyl diacrylate (Acute tox. 4* by dermal route) and the composition of the registered substance (containing 65 -100% of Butane-1,3-diyl diacrylate), the following classification is applied : Acute tox.3 for dermal route (H311).

Inhalation acute toxicity

Based on the absence of data and the absence of mandatory classification of Butane-1,3-diyl diacrylate for this endpoint, no classification of the registered substance is required for inhalation acute toxicity.