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Diss Factsheets

Administrative data

Description of key information

Oral exposure route: 

In a study the acute oral toxicity (LD50) of test substance in rats was determined to be 823 mg/kg bw.

Inhalation exposure route:

In a further study the the acute toxicity for the inhalation exposure route of test substance in rats was investigated. The LC0 was determined to be approx. 0.17 mg/L (nominal). The inhalation of a highly saturated vapour-air-mixture represents an unlikely acute hazard.

Dermal exposure route:

The acute dermal toxicity (LD50) of test substance in rats was determined to be > 2000 mg/kg bw in male and female rats. After a single skin contact the substance was considered to be virtually nontoxic.

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:
key study
Study period:
20 Jul 1979 to 03 Oct 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
BASF Test: Groups of 10 rats/sex were administered the test substance as an aqueous solution at 4 dose levels by gavage. The animals were observed for clinical signs and lethality several times on the day of administration and then once daily during the 14-day observation period. Body weights were determined after 4, 7, and 13 days. Upon completion of the study all surviving animals were sacrificed and submitted to gross-pathological examination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material: Butanediolmonoacrylate
- Substance No.: 78/278
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Spraque-Dawley / Wiga
- Weight at study initiation: 190 - 230 g (males); 160 - 170 g (females)
- Fasting period before study: 15 - 20 h before administration
- Diet (ad libitum): HERILAN MRH-HALTUNG; H. EGGERSMANN KG
- Water: e.g. ad libitum
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6.81, 10.00, 14.70, and 20.00 % (w/v)


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


Doses:
681, 1000, 1470, and 2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cageside observations were performed several times on the day of administration and daily on workdays during observation period. Body weights were determined at test start and termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ weights, histopathology
Statistics:
LD50 determination by probit analysis; chi square test for homogeneity
Sex:
male/female
Dose descriptor:
LD50
Effect level:
871 mg/kg bw
Based on:
test mat.
95% CL:
>= 780 - <= 967
Sex:
female
Dose descriptor:
LD50
Effect level:
921 mg/kg bw
Based on:
test mat.
95% CL:
>= 780 - <= 1 083
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
823 mg/kg bw
Based on:
test mat.
95% CL:
>= 680 - <= 968
Mortality:
At 2000 and 1470 mg/kg bw, all animals died within 48 hrs and 7 days after administration, respectively. At 1000 and 681 mg/kg bw 14/20 and 3/20 rats died within 48 hrs after dosing, except for one late death at the low dose that occurred in the second week of post-exposure. In general, most of the deaths occurred within 2 days after dosing; however, a few late deaths were also observed.
Clinical signs:
other: Signs of toxicity comprised dyspnoea, apathy, aggression, abnormal position, staggering, atony, paresis of the hind limbs, loss of pain reflex, loss of corneal reflex, narcosis, trembling, twitching, spastic gait, trismus, tonic-clonic convulsions, ruffle
Gross pathology:
In animals that died or were sacrificed, pathological findings included changes of the heart (acute atrial dilatation and acute congestive hyperemia) and of the stomach (mucosal erythema of the glandular stomach; petechial bleeding; superficial ulcers of the epithelium of the glandular stomach and of the forestomach; thickening of the forestomach wall; formation of buttons; and adhesion of the forestomach to the liver, peritoneum and spleen).

Mortality:

 

Dose [mg/kg bw]

Conc. [%]

No. of animals/sex

Dead animals / treated animals after

 

 

 

1 h

24 h

48 h

7 d

14 d

2000

20.0

10 m

4/10

10/10

10/10

10/10

10/10

10 f

4/10

9/10

10/10

10/10

10/10

1470

14.7

10 m

0/10

8/10

9/10

10/10

10/10

10 f

0/10

9/10

10/10

10/10

10/10

1000

10.0

10 m

0/10

7/10

8/10

8/10

8/10

10 f

0/10

4/10

6/10

6/10

6/10

681

6.81

10 m

0/10

0/10

2/10

2/10

2/10

10 f

0/10

0/10

0/10

0/10

1/10

m: male

f: female

 

 

Body weights:

 

Dose [mg/kg bw]

No. of animals/sex

Mean body weight [g] after x days

 

 

2-4 d

7 d

13 d

2000

10 m

-

-

-

10 f

-

-

-

1470

10 m

214

-

-

10 f

-

-

-

1000

10 m

209

245

272

10 f

178

189

204

681

10 m

245

267

297

10 f

179

193

211

m: male

f: female

Interpretation of results:
Category 4 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
823 mg/kg bw
Quality of whole database:
Non GLP, but scientifically well documented studies.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
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
Remarks:
Restrictions: limited documentation, no analytical monitoring of test atmosphere concentration
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
no analytical monitoring of test atmosphere concentration; 7-days observation period
Principles of method if other than guideline:
BASF Test: This test (also called inhalation hazard test) was performed in principle as described in OECD Guideline 403 (1981). It demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation. Young adult laboratory rats were purchased from a breeder. Groups of 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for a time period of 8 hours at 20 °C. The exposure time not causing lethality was tested twice. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was calculated as quotient of the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in the surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with the volatile components of the test substance.
GLP compliance:
no
Test type:
other: Inhalation Hazard Test
Limit test:
yes
Specific details on test material used for the study:
- Name of test material: Butanediol-(1,4)-monoacrylate
- Analytical purity: approx. 95 - 98 %
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Mean body weight at study initiation (mean of 3 animals):
- males: 198 (test group 1), 193 (test group 2), and 206 (control group) g;
- females: 169 (test group 1), 164 (test group 2), and 169 (control group) g

ENVIRONMENTAL CONDITIONS
no details given
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
approx. 0.17 mg/L (saturated atmosphere)
Calculated vapour saturation: based on the vapour pressure and molecular weight of the test substance, the vapour saturation was calculated to be 0.06 mg/L at 25 °C.
No. of animals per sex per dose:
3 animals/sex/dose group (two groups) = in total 6 animals/sex/dose
3 animals/sex/control group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily on workdays; group-wise determination of body weights at test start and termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.17 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: This corresponds to 170 mg/m3.
Mortality:
No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.
Clinical signs:
other: No clinical signs of toxicity were noted.
Body weight:
Body weights at test termination:
- males: 236 (test group 1), 214 (test group 2), and 263 (control group) g;
- females: 188 (test group 1), 172 (test group 2), and 181 (control group) g
Gross pathology:
At necropsy no gross-pathological findings were recorded.

The test substance concentration was estimated to be approx. 0.17 mg/L at 20 °C. Vapour saturation was calculated to be approx. 0.06 mg/L at 25 °C. Concentrations above the vapour saturation treshold should carefully be considered to be aerosols. Thus, the animals were exposed to a saturated vapour atmosphere, possibly in the presence of some aerosol particles.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
170 mg/m³ air
Quality of whole database:
Non GLP, but scientifically well documented studies.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 Mar 2005 to 27 Apr 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 24, 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
December 29, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material: Butanediolmonoacrylate
- Chemical name: 2-Propenoic acid, 4-hydroxy ester
- CAS No.: 2478-10-6
- Substance No.: 04/0667-1
- Analytical purity: 99.3 % (The analyses of the test substance were carried out at the Analytical Department of BASF AG, Germany, Analytical Report No. 04L00264.)
- Lot/batch No.: 010078 EDA 0
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Wistar/ HanRcc: WIST(SPF)
- Source: RCC Ltd. Laboratory Animal Services, Woelferstrasse 4, CH-4414 Fuellinsdorf, Switzerland
- Age at study initiation: Young adult animals (male animals approx. 8-10 weeks, female animals approx. 12-14 weeks)
- Weight at study initiation: males 257 g, females 225 g (mean)
- Fasting period before study: no
- Housing: single housing
- Diet (ad libitum): Kliba Labordiaet (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland
- Water (ad libitum): tap water
- Acclimation period: Acclimatization for at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk)
(About 40 cm2 corresponding to at least 10 % of the body surface)
- Type of wrap if used: The bandage consisted of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG and Fixomull stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with warm water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount applied: 1.92 mL/kg

Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.
Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms were performed several times on the day of administration, and at least once each workday for the individual animals.

- Necropsy of survivors performed: yes
Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice of all surviving animals.

- Other examinations performed: clinical signs, body weight, organ weights, histopathology of the application site

- Scoring of skin findings according to Draize (1959) were conducted on each animal 30 - 60 minutes after removal of the semiocclusive dressing (day 1) and several times until the end of the study (last day of the observation period).

- Assessment of the skin findings: According to Draize JH (1959): Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas.)

Statistics:
The binomial test (Snedecor GW, Cochran WG (1989). Statistical methods. 8th ed., Iowa State University Press/Ames) was used for the determination of the LD50.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality and no systemic clinical signs observed.
Mortality:
No mortality occurred.
Clinical signs:
other: No systemic clinical observations were noted in the animals.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study, except in three females, where in the region of the application site skin lesions and surface incrustations were observed.
Histopathological examination of the skin of these animals revealed full thickness necrosis.
Other findings:
Local skin findings:
Two male animals showed no local effects. In the remaining three male animals and in all female animals the following skin effects were observed at the application site: very slight to well-defined erythema, very slight edema, (severe) scaling, eczematoid skin change and detachment of superficial altered skin layers in the region of eczematoid skin change with scar-like sleek and reddened skin underneath. Findings were observed from study day 5 until study day 14 (study termination).

Under the conditions of this study, the acute dermal median lethal dose (LD50) of butandiolmonoacrylat after dermal application was found to be greater than 2000 mg/kg body weight both in male and female rats.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and guideline study

Additional information

Acute oral toxicity

There are several valid studies available that are acceptable for assessing the acute oral toxicity of test substance.

Key study:

In a study that was conducted in analogy to OECD guideline no. 401 the acute oral toxicity (LD50) of test substance in rats was investigated (BASF, 1979). Groups of 10 Sprague-Dawley rats/sex/dose were administered with doses of 681, 1000, 1470, and 2000 mg/kg bw by gavage and observed for 14 days for lethality and clinical signs of intoxication. The mortality rate was 3/20, 14/20, 20/20, and 20/20 in the 681, 1000, 1470, and 2000 mg/kg bw dose groups, respectively. The LD50 was found to be 823, 921 and 871 mg/kg bw for males, females and males and females combined, respectively (95% confidence limits: 680 - 968, 780 - 1083, and 780-967). Clinical symptoms were unspecific. Signs of toxicity were observed from 30 minutes after dosing up to nine days after dosing. In animals that died or were sacrificed, pathological findings at necropsy included changes of the heart and of the stomach. Mortality and clinical signs were considered to be secondary to corrosive, i.e. local effects caused by the test substance on the stomach.

Supporting studies:

- The study results reported in the key study are supported by another oral gavage study performed with Sprague-Dawley rats (BASF, 1976). The LD50 (oral) in rats was determined to be 832 mg/kg/bw. Groups of 5 rats/sex were administered doses of approx. 483, 708, 1040, 1529, and 2236 mg/kg bw by gavage. The animals were observed for lethality, changes in general appearance and demeanor and body weight gain during a 14-day post-exposure period.

- In a further study the acute oral toxicity (LD50) of the test item in rabbits (BASF, 1975) was determined to be ca. 520 mg/kg bw.

- The oral toxicity (LD50) of the test item in a study performed with dogs (BASF, 1975) could not be determined, due to the observed vomiting.

- In a further study on acute oral toxicity in rats (BASF, 1963) the LD50 was determined to be ca. 1030 mg/kg bw (based on active ingredient).

Acute inhalation toxicity

Key study:

The acute toxicity for the inhalation exposure route of the test substance was investigated in a study that was performed similar to the procedure described in OECD guideline 403 (BASF AG, 1976). No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20 °C with the volatile parts of the compound. The test substance concentration was estimated to be approx. 0.17 mg/L (170 mg/m3) at 20 °C. Therefore the LC0 was determined to be 0.17 mg/L.

disregarded study:

In a further study a mixture of butanediolmonoacrylate in butanediol (50 %) was investigated similar to the procedure described in OECD guideline 403. No mortality was observed when 12 rats were exposed for 8 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound. Exposure to an atmosphere that had been saturated at 100 °C: In the first trial, ten out of 12 rats died after 8 hours inhalation of an atmosphere that had been saturated at 100°C with the volatile parts of the compound. In the second trial, six out of 12 rats died after 3 hours inhalation of an atmosphere that had been saturated at 100°C with the volatile parts of the compound.

Acute dermal toxicity

Key study:

The acute dermal toxicity of test substance was investigated in a group of 5 male and 5 female Wistar rats at a single dose of 2000 mg/kg bw in a GLP-compliant acute toxicity study performed according to OECD TG 402, EU method B.3 and EPA OPPTS guideline 870.1200 (BASF AG, 2005). The test material was applied in undiluted form to the clipped skin of each animal and was covered by a semiocclusive dressing for 24 hours. No systemic signs of toxicity were noted in all animals. No mortality occurred. Two male animals showed no local effects. In the remaining three male animals and in all female animals skin effects were observed at the application site. Under the conditions of this study, the acute dermal median lethal dose (LD50) of test substance after dermal application was found to be greater than 2000 mg/kg body weight in male and female rats. The substance is considered to be virtually nontoxic after a single skin contact.

Other routes of acute toxicity

In two BASF studies (BASF AG, 1963 and BASF AG, 1976) the test substance was administered ip to groups of 5 mice per dose. An LD50 of ca 360 mg/kg bw and of 478 to 707 mg/kg bw was determined, respectively.

Justification for classification or non-classification

Based on the available data, the test substance has to be classified and labelled for acute oral toxicity as Category 4, H302 (Harmful if swallowed) in accordance withEU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the data, classification for acute dermal and inhalative toxicity in not warranted in accordance withEU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. The inhalation of a highly saturated vapour-air-mixture represents an unlikely acute hazard.