Registration Dossier

Administrative data

Description of key information

Several read across substances were tested in two oral studies, in two acute inhalation studies and in one dermal study. The read across substances revealed an oral LD50 > 5570 mg/kg bw. The read across substances revealed an inhalation LC50 (8h) > 0.69 mg/L air. The LD50 (dermal, rat) was > 5000 mg/kg bw.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: BASF-Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion (30%) with traganth
Doses:
0.2, 1.6, 3.2, and 6.4 mL/kg bw (corresponding to 174, 1392, 2784, and 5568 mg/kg bw)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
The study was conducted according to an internal BASF method which in principle is comparable to the methods described in OECD Guideline 401. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in aqueous emulsion with traganth.
Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 570 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
No mortality.
Clinical signs:
The animals of the highest dose group showed slight apathy and piloerection during the first 24 hours. Among the animals of the next two dose groups (2784 and 1392 mg/kg bw) slight apathy was also observed. No other clinical signs were recorded. All symptoms disappeared within the first day of the experiment.
Body weight:
Mean body weight at test start: 243 g (male); 173 g (female)
Gross pathology:
No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period.
Mortality:
----------
Dose No. of Cumulative mortality after
[mg/kg bw] animals 1 h 24 h 48 h 7 d
-----------------------------------------------------------
5568 10 0/10 0/10 0/10 0/10
2784 10 0/10 0/10 0/10 0/10
1392 10 0/10 0/10 0/10 0/10
174 10 0/10 0/10 0/10 0/10
-----------------------------------------------------------

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 570 mg/kg bw
Quality of whole database:
Comparable to guideline study with acceptable restrictions

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
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Principles of method if other than guideline:
Method: BASF-Test
GLP compliance:
no
Test type:
other: Inhalation hazard test
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
0.69 mg/L
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
This test (also called inhalation risk test) was performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (here 20 °C). Groups of 3 rats per sex were exposed to the vapors, 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 8 hours. For confirmation of the results, the experiment was repeated once. 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 and the amount of air used during the 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. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination. 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 volatile components of the test substance.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.69 mg/L air
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: no mortality occured
Mortality:
No mortality occurred within 8 hours and during the post-exposure period of 7 days after inhalation of a highly saturated vapor-air mixture of the test compound.
Clinical signs:
other: No clinical signs or symptoms were noted.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
690 mg/m³
Quality of whole database:
Comparable to guideline study with acceptable restrictions

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:
Oct - Nov 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Regulation (EC) No 1907/2006
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay, Labor fuer biologische Analytik GmbH
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: young adult animals (male approx. 8 weeks, female approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight, actual weights)
- Housing: single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°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: 40 cm²
- % coverage: 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing: yes (rinsing of the application site with warm water)
- Time after start of exposure: 24 hours after Application
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical oberservation: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Very slight to severe erythema (grade 1 to 4). Very slight to moderate edema (grade 1 to 3). Incrustations. Severe scaling. Additionally, all local signs were noted beyond the application site.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Under the conditions of this study the median lethal dose (LD50) of Laurylacrylate 1214 after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.
Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10 % of the total body surface area. The animals were observed for 14 days.

The following test item-related effects were recorded during the course of the study:

- No mortality occured

- No signs of systemic toxicity

- Very slight to severe erythema (grade 1 to 4)

- Very slight to moderate edema (grade 1 to 3)

- Incrustrations

- Severe scaling

- Additionally, all local signs were noted beyond the application site.

- The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week...

- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 5000 mg/kg bw in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
GLP study.
OECD guideline was followed.

Additional information

Acute oral toxicity:

In the key study, a read across substance (mixture of laurylacrylate (CAS No.: 2156-97-0) and tetradecylacrylate (CAS No.: 21643-42-5)) was tested according to an internal BASF method which in principle is comparable to the methods described in OECD Guideline 401. The doses were 0.2, 1.6, 3.2, and 6.4 mL/kg bw (corresponding to 174, 1392, 2784, and 5568 mg/kg bw). Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in aqueous emulsion with traganth. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination. No mortality was revealed. The animals of the highest dose group showed slight apathy and piloerection during the first 24 hours. Among the animals of the next two dose groups (2784 and 1392 mg/kg bw) slight apathy was also observed. No other clinical signs were recorded. All symptoms disappeared within the first day of the experiment. No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period. The read across substances Lorolacrylat 1214 revealed an oral LD50 > 5570 mg/kg bw.

 

In the supporting study, a read across substance (mixture of acrylic esters of saturated unbranched alcohols with C10-C16 carbon chain length) was tested according to an internal BASF method which in princile is comparable to the methods described in OECD Guideline 401. The doses were 0, 0.2, 1.6, 6.4, and 10.0 mL/kg bw (corresponding to approx. 0, 174, 1392, 5568, and 8700 mg/kg bw). Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in aqueous emulsion with traganth. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination. No mortality was revealed. No clinical signs or symptoms were observed during the study. No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period.

 

Acute inhalation studies:

In the key study, a read substance (mixture of laurylacrylate (CAS No.: 2156-97-0) and tetradecylacrylate (CAS No.: 21643-42-5)) was tested according to an internal BASF method which in principle is comparable to the methods described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (here 20 °C). Groups of 3 rats per sex were exposed to the vapors, 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 8 hours. For confirmation of the results, the experiment was repeated once. 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 and the amount of air used during the 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. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination. 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 volatile components of the test substance. No mortality occurred within 8 hours and during the post-exposure period of 7 days after inhalation of a highly saturated vapor-air mixture of the test compound. No clinical signs or symptoms were noted. No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period.

 

In supporting study, a read substance (mixture of acrylic esters of saturated unbranched alcohols with C10-C16 carbon chain length) was tested performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (here 23 °C). Groups of 3 rats per sex were exposed to the vapors, generated by bubbling 100 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 hours. For confirmation of the results, the experiment was repeated once. No analytical determination of the atmosphere concentrations was performed. The nominal concentration could not be calculated in this test, since several times during the 8-hr exposure period etingal A and silicon oil had been added to the test substance in order to prevent frothing. 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. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination. 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 volatile components of the test substance. No mortality occurred within 8 hours and during the post-exposure period of 7 days after inhalation of a highly saturated vapor-air mixture of the  test compound. No macroscopic pathologic abnormalities were noted in the surviving animals examined at the end of the observation period.

 

Acute dermal toxicity:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted read across substance (CAS no. 84238-60-8) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality occurred. No signs of systemic toxicity was observed ( Very slight to severe erythema (grade 1 to 4), Very slight to moderate edema (grade 1 to 3)). No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitabke for classification purposes under Regulation 1272/2008. No mortality occured at the limit dose of 5000 mg/kg bw in an acute oral and an acute dermal toxicity study. Additionally, no mortality occured in an acute inhalation toxicity study. As a result the substance is not considered to be classified for acute oral, dermal or inhalative toxicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.