Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Materials and methods

Principles of method if other than guideline:

Standard acute method. Study conducted pre-GLP.

GLP compliance:

no

Remarks:

study conducted pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

EC Number:

231-403-1

EC Name:

Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

Cas Number:

7534-94-3

Molecular formula:

C14H22O2

IUPAC Name:

1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate

Details on test material:

Purity not specified, but > 98% commercial grade assumed.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 179 - 223 g males and 199 - 230 g females
- Fasting period before study: three to four hours prior dosing
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

corn oil

Remarks:

10% v/v suspension in corn oil for the 464 µL/kg dose level. Undiluted for the remaining dose levels.

Doses:

464 (10% v/v) suspension in corn oil, 1000, 2150, 4640, and 10000 µL/kg (undiluted) for both sexes. A female group received an additional dose of 21500 µL/kg.

No. of animals per sex per dose:

Total number of animals: 55
5 per sex per dose

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: for mortality and toxicity immeldiately after dosing; 1, 4, and 24 hours post-dosing; and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3.16 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

6.81 mL/kg bw

Based on:

test mat.

Mortality:

please see table 1 (Any other information on results incl. tables)

Clinical signs:

other: Depression, hunched appearence, ataxia, excessive urination, and labored respiration.

Other findings:

Necropsy findings: Females at 464 and 4640 µL/kg exhibited yellow appearing contents at sacrifice; gastrointestinal inflammation andf/or congerstion of the lung lobes was observed in dead animales at the two highest levels.

Any other information on results incl. tables

Table 1: Mortality

test concentration [µL/kg]	dead male/total dosed	dead feamale/total dosed
464	0/5	0/5
1000	0/5	0/5
2150	1/5	0/5
4650	4/5	0/5
10000	5/5	5/5
21500	not tested	5/5

Further observations:

Males: Evidence of excessive urination and body weight loss in one animal at the 464 and 1000 µL/kg level, respectively; death in one animal by 24 hours at the 2150 µL/kg level; slight depression, depressed righting and placement reflexes and evidence of excessive urination at the 4650 and 10000 µL/kg level; labored respiration ataxia, red-tinged crusts surrounding the eyes and nares, hunched appearance, weight loss and unkempt fur in one or two animals at the 4640 µL/kg level.

Females: Slight depression and unkempt fur at the 464 µL/kg level; evidence of excessive urination in one animal each at the 464 and 2150 µL/kg levels; depression, hunched appearance, unkempt fur, and/or evidence of excessive urination and/or duarrhea at the 4640, 10000 and 21500 µL/kg levels; labored respiration, ataxia, bloody-appeareing stains on the face and ptosis at the 10000 and 21500 µL/kg levels.

Necropsy findings: Females at 464 and 4640 µL/kg exhibited yellow-appearing contents at sacrifice; gastrointestinal inflammation and/or congestion of the lung lobes was observed in dead animals at the two highest levels.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Classification based on the criteria of 286/2011/EU Criteria used for interpretation of results: EU

Conclusions:

According to the test result: LD50(14days): 3160 mg/kg bw (male rats) the test substance Isobornyl methacrylate has to be classified as practically
nontoxic in rats in respect of its acute oral toxicity (EU GHS criteria; classification based on the criteria of 286/2011/EC).

Executive summary:

In an acute oral toxicity study according to standard acute method conducted pre-GLP, groups of fasted male and female Sprague-Dawley rats were given a single oral dose of Isobornyl methacrylate at a dose levels of  464 (10% v/v) suspension in corn oil, 1000, 2150, 4640, and 10000 µL/kg (undiluted) for both sexes. A female group received an additional dose of 21500 µL/kg. and observed for 14 days.

 

Oral LD₅₀Combined = > 2000 mg/kg bw

   

Isobornyl methacrylate is oral practically non toxic in Spraque-Dawley rats (EU GHS no category) based on this LD₅₀test in males and female rats.

UN GHS: Category 5

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.