Registration Dossier

No acute study is available on the registered substance (reaction mass of C12 -C13 acrylate). However the data are available on an analogue substance (reaction mass of C12 -C14 acrylate). Indeed, Laurylacrylate (C12 -C14 acrylate) didn't showed mortality at the highest tested doses after oral (LD0> 5570 mg/kg), dermal (LD0> 5000 mg/kg) and inhalation (LC0> 0.69 mg/L) single exposure in rats.

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

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.

Statistics:

no

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 5 570 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

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

Conclusions:

Based on the results, the oral LD50 of laurylacrylate is higher than 5570 mg/kg bw in rats.

Executive summary:

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. 4 doses were tested : 174, 1392, 2784 and 5568 mg/kg bw

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. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination.

No mortality was observed in the study. 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 animals examined at the end of the observation period.

Based on the results, the oral LD50 of laurylacrylate is higher than 5570 mg/kg bw in rats.

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 570 mg/kg bw

Quality of whole database:

The study is considered to be reliable with a klimisch score of 2.

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

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

Vehicle:

other: none

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 thelength of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance.

Statistics:

no

Sex:

male/female

Dose descriptor:

LC0

Effect level:

> 0.69 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

not determinable due to absence of adverse toxic effects

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

Conclusions:

Based on the results, the LC0 of laurylacrylate was higher than 0.69 mg/l in rats exposed to vapors for 8 hours.

Executive summary:

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 for 8 hours. For confirmation of the results, the experiment was repeated once.

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. 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 and no clinical sign 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. Moreover no macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.

Based on the results, the LC0 of laurylacrylate was higher than 0.69 mg/l in rats exposed to vapors for 8 hours.

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

0.001 mg/m³

Quality of whole database:

The study is considered to be reliable with a klimisch score of 2.

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Regulation (EC) No 1907/2006

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

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system 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:

LD0

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

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.

Interpretation of results:

GHS criteria not met

Conclusions:

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.

Executive summary:

The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats (OECD 402).

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

No unscheduled deaths and no clinical signs indicative of systemic toxicity were observed in any animals.

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. 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.

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.

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

The study is considered to be reliable with a klimisch score of 1.

Oral acute toxicity on analogue substance (1964):

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. 4 doses were tested : 174, 1392, 2784 and 5568 mg/kg bw

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. Upon completion of the study, all animals were sacrificed and submitted to gross-pathological examination.

No mortality was observed in the study. 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 animals examined at the end of the observation period.

Based on the results, the oral LD50 of laurylacrylate is higher than 5570 mg/kg bw in rats.

Inhalation acute toxicity on analogue substance (1964):

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 for 8 hours. For confirmation of the results, the experiment was repeated once.

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. 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 and no clinical sign 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. Moreover no macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.

Based on the results, the LC0 of laurylacrylate was higher than 0.69 mg/l in rats exposed to vapors for 8 hours.

Dermal acute toxicity on analogue substance (2012):

The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats (OECD 402).

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

No unscheduled deaths and no clinical signs indicative of systemic toxicity were observed in any animals.

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. 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.

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.

Based on the data available, no classification for acute toxicity is required for the reaction mass of C12 -C13 acrylate according to the Regulation EC n°1272/2008.