Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat): > 2000 mg/kg bw

LD0 (inhal, rat): > 0.9 mg/L

LD50 (dermal, rabbit): > 3000 mg/kg

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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
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
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (+/- 20% of the mean weight)
- Fasting period before study: at least 16 hours before administration
- Housing: Makrolon cage, type III; single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- 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

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight,organ weights, pathology
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in both 2000 mg/kg bw test groups.
Clinical signs:
No clinical signs were observed in both 2000 mg/kg bw test groups during clinical examination.
Body weight:
The body weights of the animals increased within the normal range throughout the study period with one exception in the first test group. One animal gained weight in a normal range during the first observation week but the body weight only slightly increased during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.
Gross pathology:
There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females).

Mortality

Dose (mg/kg bw):

2000

2000

Sex:

female

female

Administration:

1

2

No. of animals

3

3

Mortality (animals)

No mortality

No mortality

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the median lethal dose of C9-11 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:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
guideline study

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
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OSHA toxicity screening test. Limited documentation of the study.
Guideline:
other: OSHA Toxicity Screening Test
GLP compliance:
no
Test type:
other: saturated atmosphere
Limit test:
yes
Species:
rat
Strain:
other: Albino
Details on test animals and environmental conditions:
Average body weight: 190 grams
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: inhalation chamber
- Exposure chamber volume: 325 liter
- Source and rate of air: Air flow- thru generator, 9.9 L/min at 29.92 mm Hg
- Temperature: 25 °C
Time allotted for equilibrium: 161 min



Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
1 h
Concentrations:
Average nominal concentration = 0.9 mg/L air
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
not specified
Dose descriptor:
LC0
Effect level:
> 0.9 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Mortality:
No deaths.
Clinical signs:
other: No untoward behavioral reactions.
Body weight:
The average body weight gain was 52 grams.
Gross pathology:
Necropsy examinations revealed no gross pathologicc alterations.
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute inhalation toxicity study on Isodecyl methacrylate with Albino Rats, no signs of toxicity were observed within a 14 day observation period after one-hour exposure to a saturated atmosphere (0.9 mg/L) at 35 °C.
Executive summary:

In an OSHA toxicity screening test in Albino rats on acute inhalation toxicity with Isodecyl methacrylate, no mortalities, behavioral abnormalities or gross pathologic alterations were observed after one hour exposure within a 14 day observation period.

The determined LC0 was > 0.9 mg/L at 35 °C (saturated atmosphere).

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OSHA Toxicity Screening Test. Limited documentation of the study.
Guideline:
other: OSHA Toxicity Screening Test
GLP compliance:
no
Test type:
other: single dose
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Doses:
Dosage: 3000 mg/kg
No. of animals per sex per dose:
6
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Mortality:
In the observation period of 14 days, 2 of 6 experimental animals died.
Clinical signs:
As signs of intoxiciation, only hypoactivity was reported.
Interpretation of results:
practically nontoxic
Conclusions:
In an acute dermal toxicity study on Isodecyl methacrylate with Albino Rabbits, an LD50 > 3000 mg/kg was observed.
Executive summary:

In an OSHA toxicity screening test in Albino rabbits on acute dermal toxicity with Isodecyl methacrylate, the test substance was administered undiluted with a dosage of 3000 mg/kg. b.w.

As sign of intoxication, hypoactivity is reported.

The determined LD50 was > 3000 mg/kg.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw

Additional information

Acute oral:

In an acute oral toxicity study performed according to the Acute Toxic Class Method, 2000 mg/kg bw of the undiluted test item C9-11 Methacrylate were administered by gavage to two test groups of three fasted Wistar rats each (6 females). No mortality occurred. No clinical signs were observed. The body weights of the animals increased within the normal range throughout the study period with one exception in the first test group. One animal gained weight in a normal range during the first observation week but the body weight only slightly increased during the second week. This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (6 females). Under the conditions of this study the median lethal dose of C9-11 Methacrylate after oral administration was found to be greater than 2000 mg/kg bw in rats (BASF, 2017).

No data are available for inhalation and dermal toxicity, but for Isodecyl methacrylate (Cas: 29964-84-9).

Acute inhalation:

In an OSHA toxicity screening test in Albino rats on acute inhalation toxicity with Isodecyl methacrylate, no mortalities, behavioral abnormalities or gross pathologic alterations were observed after one hour exposure within a 14 day observation period. The determined LC0 was > 0.9 mg/L at 35 °C (saturated atmosphere) (Evonik, 1973).

Acute dermal:

In an OSHA toxicity screening test in Albino rabbits on acute dermal toxicity with Isodecyl methacrylate, the test substance was administered undiluted with a dosage of 3000 mg/kg. b.w. In the observation period of 14 days, 2 of 6 experimental animals died. As sign of intoxication, hypoactivity is reported. The determined LD50 was > 3000 mg/kg (Evonik, 1973).

Justification for classification or non-classification

Based on the results, the test item is no subject to classification and labelling according to Regulation (EC) No 1272/2008 (CLP).