Reaction mass of nonyl methacrylate and decyl methacrylate and undecyl methacrylate

Endpoint summary

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

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system 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:

other: No clinical signs were observed in both 2000 mg/kg bw test groups during clinical examination.

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 or test system 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:

other: 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).