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

Endpoint summary

Description of key information

LD50 oral, rat: 4350 mg/kg bw

LD50 dermal, rabbit: > 30000 mg/kg

inhalation: no data available/ no relevant pathway of exposure due to the low VP

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

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Remarks:

Study conducted pre-GLP.

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

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Seventy male Wistar albino rats weighing between 200 and 300 g were used. The animals were fed, housed and watered in accordance with standard laboratory procedures.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test animals were fasted for a period of app. 24 hrs prior to testing. The test material was administered as a single dosage.

Doses:

Control = 0, 3000, 3500, 4000, 4500, 5000, 6000 mg/kg

No. of animals per sex per dose:

Total number of animals: 70
10 anmals per dose

Control animals:

yes

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, 3, 6, 24, 48, and 72 hours post-dosing; and daily thereafter for a total of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Sex:

male

Dose descriptor:

LD50

Effect level:

5 750 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 24 hrs

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

4 350 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 14 d

Mortality:

please see attached table

Clinical signs:

other: Depression, burrowing, twitching, staggering, abnormal gait, straub tail, clonic convulsions, tremors, respiratory depression, piloerection, and rates of death. Details see attached table.

Interpretation of results:

not classified

Remarks:

Migrated information EU 1272/2008 Criteria used for interpretation of results: EU

Conclusions:

According to the test result: LD50(14days): 4350 mg/kg bw (male rats) the test substance Isobornyl acrylate has not to be classified with respect to acute oral toxicity (EU GHS criteria; 1272/2008/EU).

Executive summary:

In an acute oral toxicity study according to standard acute method conducted pre-GLP, groups of fasted male Wistar rats obtained a single oral dose of Isobornyl acrylate at a doses up to 6000 mg/kg and were observed for 14 days.

 

Oral LD₅₀= 4350 mg/kg bw

   

Isobornyl acrylate has a low acute toxic potential in rats (EU GHS: no category) based on this test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 350 mg/kg bw

Quality of whole database:

reliable

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

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Standard acute method. Study conducted pre-GLP.

Guideline:

other: pre-guideline

GLP compliance:

no

Remarks:

Study conducted pre-GLP.

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

Twelve male New Zealand albino rabbits, in a weight range of between 2.3 and 3.0 kilograms, were used in this experiment. The animals were fed, housed, and maintained in accordance with standard laboratory procedures.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The animals were immobilized in an animal holder and the trunks clipped free of hair with an Oster animal clipper. One-half of the animals were further prepared by making epidermal abrasions every two or three centimetres longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum but not deep enough to disturb the derma. The test material was introduced over approximately 10.7 % of the animal body surface and held in contact with skin by means of a sleeve for a period of twenty-four hours at which time the sleeve was removed and the treated areas wiped clean of the remaining excess of the material.

Duration of exposure:

24 hrs

Doses:

3000 mg/kg

No. of animals per sex per dose:

12

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: not reported

Gross pathology:

not reported

Other findings:

not reported

Interpretation of results:

GHS criteria not met

Remarks:

1272/2008/EU Criteria used for interpretation of results: EU

Conclusions:

According to the test result: LD50(14days): > 3000 mg/kg bw (male rats) the test substance Isobornyl acrylate has not to be classified with respect to acute dermal toxicity (EU GHS criteria; 1272/2008/EU).

Executive summary:

In an acute dermal toxicity study according to standard method conducted pre-GLP, a group of fasted male New Zealand rabbits was administered dermally a single oral dose of 3000 mg/kg body weight Isobornyl acrylate. The observation period was 14 days.

 Result:

Dermal LD₅₀ >3000 mg/kg bw   

Isobornyl acrylate has a low acute toxic potential in rabbits (EU GHS: no category) based on this test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

3 000 mg/kg bw

Quality of whole database:

reliable

Additional information

Isobornyl acrylate is of low toxicity by the oral (LD50 rat = 4350 mg/kg) and dermal route (LD50 rabbit > 3000 mg/kg) in reliable pre-guideline studies.

Due to the low vapour pressure of the substance, inhalation is not considered as a relevant pathway of exposure.

Justification for classification or non-classification

According to the criteria as of directive 1272/2008/EC, no classification is warranted for the acute toxicity.

According to the criteria as of UN-GHS, Cat 5 oral is warranted for the acute toxicity.