Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute Oral Toxicity: REACH_LD50 > 5000 mg/kg bw | rat | - | #key study#


Acute Dermal Toxicity: REACH_LD50 > 5000 mg/kg bw | rat | - | #key study#

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: TRD Protocol No. 30, Book 1, p.389
Principles of method if other than guideline:
Single Oral Dose
Species Albino Male Rat
Condition: Animals fasted for 24 hours were dosed with the product as received.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
No specific details on test material.
Species:
rat
Strain:
other: CF Nelson
Sex:
male
Details on test animals or test system and environmental conditions:
Species: Albino Male Rat
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Animals fasted for 24 hours were dosed with the product, as received.
Doses:
5.0 g/kg
No. of animals per sex per dose:
Ten
Control animals:
no
Details on study design:
No further details specified.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One male died on day 3.
Clinical signs:
other: Signs of intoxication: Piloerection, lethargy, prostration, ataxia.
Gross pathology:
Gross autopsy on survivors found no visible lesions.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 greater than 5000 mg/kg
Executive summary:

Single Oral Dose: Species Albino Male Rat

Condition: Animals fasted for 24 hours were dosed with the product as received.

Dosage: 5.0 g/kg

Died/dosed: 1/10

LD50 greater than 5.0 g/kg

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: TRD Protocol No. 31, Book 7, p.194
Principles of method if other than guideline:
Single Dermal Dose
Species Albino Male Rabbit
Condition: The product, as received, was held under an impervious cuff in continuous 24 hour contact with closely shaven skin.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
No specific details on test material.
Species:
rabbit
Strain:
other: Albino
Sex:
male
Details on test animals or test system and environmental conditions:
Species: Albino Male Rabbit
Type of coverage:
other: Impervious cuff
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The product, as received, was held under an impervious cuff in continuous 24 hour contact with closely shaven skin.
Duration of exposure:
24 hours
Doses:
5.0 g/kg
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
No further details specified.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One male died on Day 7.
Clinical signs:
other: Signs of intoxication: Lethargy, soft feces, diuresis. Skin Irritation: Severe erythema and edema followed by eschar formation.
Gross pathology:
Gross autopsy on survivors found one animal had 2 yellow-white lesions of the left kidney.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 greater than 5000 mg/kg
Executive summary:

Single Dermal Dose

Species: Albino Male Rabbit

Condition: The product, as received, was held under an impervious cuff in continuous 24 hour contact with closely shaven skin.

Dosage: 5.0 g/kg

Died/dosed: 1/5

LD50 greater than 5.0 g/kg

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw

Additional information

Justification for classification or non-classification

The test item was submitted to acute oral toxicity testing in male rats at a dose of 5000 mg/kg. Observed clinical signs were piloerection, lethargy, prostation and ataxia. On day 3 one animal died.


The oral LD50 is therefore > 5000 mg/kg.


 


Dermal application of the test item at a dosage of 5000 mg/kg for 24 hours under an impervious cuff onto the shave skin of male rabbits resulted in severe erythema and edema formation. Observed clinical signs were lethargy, soft faeces and diuresis. One animal died on day 7. The oral LD50 is therefore > 5000 mg/kg.


 


Reaction mass of 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-5-yloxy)ethyl acrylate and 2-(3a,4,5,6,7,7a-hexahydro-1H-4,7-methanoinden-6-yloxy)ethyl acrylate does therefore not fulfil  the classification criteria for acute oral and dermal toxicity and does not require classification.