1-Propanol, 2-methyl-3-[(1,7,7-trimethylbicyclo[2.2.1]hept-2-yl)oxy]-

Endpoint summary

Description of key information

- Oral LD50: > 2000 mg/kg bw (OECD TG 401)
- Inhalation LC50 > 5200 mg/m3 (route-to-route extrapolation from acute oral toxicity study)
- Dermal LD50: > 2000 mg/kg (OECD TG 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

One acute oral toxicity study is available, which is performed according to OECD guidelines and under GLP conditions. This study is adequate for covering this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity

A study according to OECD guideline 401 was performed to assess the acute oral toxicity of Bornafix to the rat. A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, as supplied, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths. Clinical signs of reaction to treatment were limited to pilo-erection, abnormal body carriage (hunched posture), diarrhoea and increased salivation; recovery was complete by Day 2. All rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal oral dose to rats of Bornafix was found to be greater than 2.0 g/kg bodyweight.

Acute inhalation toxicity

Using route to route extrapolation the inhalation toxicity can be derived as follows: an oral LD50 of > 2000 mg/kg bw can be roughly converted into > 5200 mg/m3 (ECHA's CLP guidance, section, 3.1.3.3.5, 2017, using the formula: 1 mg/kg bw = 0.0052 mg/L/4h). In the present case 50/100% oral and inhalation absorption is used. The maximum saturated vapour pressure for the substance is 62 mg/m3 (0.67 x 226 MW (g/mol)) / (8.3 (R, gas constant) x 293 (°K)). This means that the substance cannot reach a concentration higher than 62 mg/m3. Therefore, an LC50 for inhalation cannot be reached and no classification and labelling is needed for the acute inhalation route.

Acute dermal toxicity

A study according to OECD 402 was performed to assess the acute dermal toxicity of Bornafix to the rat. A group of ten rats (five males and five females) was given a single occlusive dermal application of the test substance, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. Slight erythema with no oedema was observed at the sites of application of the test substance for all rats on Day 2 and in females only on Days 3 and 4. There were no other dermal changes and irritation had resolved by either Day 3 (males) or Day 5 (females). Slightly low bodyweight gains were recorded for four males and four females on Day 8 and in one male and two females on Day 15; the remaining rats achieved anticipated gains on Day 15. All other rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal dermal dose to rats of Bornafix was found to be greater than 2.0 g/kg bodyweight.

Justification for classification or non-classification

The substance does not have to be classified for acute for oral, dermal and inhalation toxicity according to EU CLP (EC No. 1272/2008 and its amendments).