Registration Dossier

Administrative data

Description of key information

LD50(rat) oral: > 2000 mg/kg bw (BASF, 2014)
LD50(rat) dermal: > 5000 mg/kg bw (BASF, 2014)

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Housing: Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Other examinations performed: clinical signs, body weight, pathology
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
In both test groups no mortality occurred.
Clinical signs:
In the first administration group all animals showed impaired general state and piloerection from hour 2 until hour 5.
In all animals of the second administration group impaired general state and piloerection were observed from hour 1 until hour 4.
Body weight:
The mean body weight increased within the normal range throughout the study period with two exceptions in the second test group. Two animals did not gain weight properly in the second week.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Mortality

Dose (mg/kg bw):

2000

2000

Sex:

female

female

Administration:

1

1

No. of animals

3

3

Mortality (animals)

No mortality

No mortality

Under the conditions of this study the median lethal dose of C 17 Methacrylate after oral administration was found to be greater than 2000 mg/kg bw in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight, actual weights)
- Housing: Makrolon cage, type III, Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Afterwards removal of the semi-occlusive dressing, rinsing of the application site with warm water
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, pathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed in male and female rats during clinical examination.
Three out of five male animals revealed very slight erythema (grade 1) from study day 1 until day 2 or 3, respectively. One out of five female animals revealed very slight erythema (grade 1) from study day 1 until day 2.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
The body weight of four female animals stagnated during the first post-exposure week, but increased normally during the second week. The fifth female showed stagnation of body weight throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Mortality

Dose (mg/kg bw):

5000

5000

Sex:

female

male

Administration:

1

1

No. of animals

5

5

Mortality (animals):

No mortality

No mortality

Under the conditions of this study the median lethal dose (LD50) of C 17 Methacrylate after dermal application was found to be greater than 5000 mg/kg bw in male and female rats.

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

Additional information

oral

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the undiluted test item C 17 Methacrylate were administered by gavage to two test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females). No mortality occurred. The following test substance-related clinical observations were recorded, clinical signs occurred within the first 5 hours after administration. Impaired general state in all animals and piloerection in all animals. The mean body weight increased within the normal range throughout the study period with two exceptions in the second test group. Two animals did not gain weight properly in the second week. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. Under the conditions of this study the median lethal dose of C 17 Methacrylate after oral administration was found to be greater than 2000 mg/kg bw in rats.

dermal

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 test item C 17 Methacrylate (undiluted) 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 signs of systemic toxicity were observed. No mortality occurred. The following test item-related local effects were recorded during the course of the study, local effects occurred within the first 3 days after administration. Very slight erythema (grade 1) in three males and one female. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of four female animals stagnated during the first post-exposure week, but increased normally during the second week. The fifth female showed stagnation of body weight throughout the study period. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

Based on the available studies data on acute toxicity properties the test item does not have to be classified and labelled according to Regulation (EC) No 1272/2008 (CLP).