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

Endpoint summary

Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 > 5000 mg/kg bw

Acute inhalation toxicity derived by route to route extrapolation LC50 >13000 mg/m3

Acute dermal toxicity (similar to OECD TG 402): LD50 > 5000 mg/kg bw

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study was performed predating current guidelines

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study was performed pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals in total

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: clinical signs

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

2 animals died during the 14 day observation period (day 3 and day 4).

Clinical signs:

other: Lethargy and urinary incontinence were observed

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (EC No.1272/2008 and its updates)

Conclusions:

The acute oral toxicity test showed an LD50 of > 5000 mg/kg bw

Executive summary:

A pre-GLP and pre-guideline study, equivalent to OECD TG 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 5000 mg/kg bw and observed for 14 days. 2/10 animals died on day 3 and 4. Clinical signs included lethargy and urinary incontinence. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to exceed 5000 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful following oral exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

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:

comparable to guideline study with acceptable restrictions

Remarks:

Study was performed predating current guidelines

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

Study was performed pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

Not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 animals in total

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Other examinations performed: clinical signs

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in the 14-day observation period

Clinical signs:

other: No clinical signs were reported

Interpretation of results:

other: Not acute harmful

Remarks:

in accordance with EU CLP (EC No. 1272/2008 and its updates)

Conclusions:

The acute dermal toxicity test showed an LD50 above 5000 mg/kg bw.

Executive summary:

A pre-GLP and pre-guideline study, equivalent to OECD TG 402, was performed to identify the acute dermal toxicity of the test substance. In this study 10 rabbits (sex unspecified) were exposed to 5000 mg/kg bw test substance on the skin. No mortality was observed in the 14 day observation period, and no clinical signs were noted. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits exceeded 5000 mg/ kg bw. Based on these results, the test substance is not considered to be acutely harmful following dermal exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

A pre-GLP and pre-guideline study, equivalent to OECD TG 401, was performed to identify the acute oral toxicity of the test substance (Moreno 1973). In this study 10 rats (sex unspecified) were administered with 5000 mg/kg bw and observed for 14 days. 2/10 animals died on day 3 and 4. Clinical signs included lethargy and urinary incontinence. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to exceed 5000 mg/kg bw. Based on these results, the test substance is not considered to be acute harmful following oral exposure.

Acute inhalation toxicity

The acute inhalation toxicity for the substance can be derived using data on the acute oral toxicity using the methodology which is described in the ECHA Guidance on the Application of the CLP Criteria (2017; 3.1.5.1.8. Example 8, page 264): using the extrapolation formula 1 mg/kg bw = 0.0052 mg/L/4h. The LD50 of the substance for acute oral toxicity exceeds 5000 mg/kg bw. This value can be converted to > 26 mg/L/4h or 26 g/m3/4h. Taking into account the inhalation absorption as 100% and oral absorption 50%, the acute inhalation toxicity would become > 13 g/m3/4h or 13000 mg/m3/4h. The maximum saturated vapour concentration for the substance is 264 mg/m3 (3.1 Pa (vapour pressure) x 210.31 (MW)) / (8.3 (R, gas constant) x 297 (°K)). Thus, the substance cannot reach a vapour concentration higher than 264 mg/m3. The extrapolated inhalation LC50 cannot be reached because it exceeds the saturated vapour concentration by more than a factor of 49.

Acute dermal toxicity

A pre-GLP and pre-guideline study, equivalent to OECD TG 402, was performed to identify the acute dermal toxicity of the test substance (Moreno 1973). In this study 10 rabbits (sex unspecified) were exposed to 5000 mg/kg bw test substance on the skin. No mortality was observed in the 14 day observation period, and no clinical signs were noted. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits exceeded 5000 mg/ kg bw. Based on these results, the test substance is not considered to be acutely harmful following dermal exposure.

Justification for classification or non-classification

Based on the available information classification and labelling for acute oral, dermal and inhalation toxicity is not warranted in accordance with EU CLP (EC No. 1272/2008 and its amendments).