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Administrative data

Description of key information

The key study on acute oral toxicity in rat reports the LD50 value of >5000 (Biolab 1991;rel 2). The key study for acute inhalation toxicity reports the LC50 value to be >saturated vapour concentration (Blair 1980; rel 2). The acute dermal key finding is an LD50 value of 3320 mg/kg (Clark& Coombs, 1978; rel 2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
The selected study was conducted according to an appropriate OECD guideline, and was the most recent of the available studies.

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
Dose descriptor:
LD50
Value:
3 320 mg/kg bw

Additional information

The most recent and high reliability data were assigned as key studies. In addition to the key information, high reliability supporting studies were available for all the acute toxicity endpoints, which of the results were in accordance with the key findings.

In the key oral toxicity study conducted according to OECD TG 401 the LD50 for Alcohols, C12-16 was concluded to be > 5000 mg/kg bw in rats (Biolab, 1991).

In an acute oral toxicity study conducted according to generally accepted scientific principles the LD50 for Alcohols, C12-15 was concluded to be 26400 mg/kg bw in rats (Shell, 1964).

Based on the available information from an acute oral toxicity study LD50 for Alcohols, C12-16 was concluded to be 4450 mg/kg bw in rats. The study was not conducted according to the current OECD test guideline requirements. It does, however, add weight of evidence for hexan-1-ol (Henkel, 1970).

In a key oral toxicity study conducted according to a protocol similar to OECD TG 401 the LD50 for Alcohols, C12-16 was concluded to be > 8300 mg/kg bw in rats (Clark & Coombs, 1978).

In the key inhalation toxicity study conducted according to a protocol similar to OECD TG 403 the LC50 for Alcohols, C12-16 was concluded to be greater than the saturated vapour concentration (Blair, 1980).

In the key dermal toxicity study conducted according to a protocol similar to OECD TG 402 the LD50 for Alcohols, C12-16 was concluded to be > 3320 mg/kg bw in rat (Clarks & Coombs, 1978).

In a dermal toxicity study conducted according to a protocol similar to OECD TG 402 the LD50 for Alcohols, C12-16 was concluded to be > 10200 mg/kg bw in rabbit (Shell, 1964).

 

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

Acute toxicity tests of the linear and essentially linear alcohols do not indicate any potential hazard for acute, dermal or inhalation toxicity. Tests on various substances included in this category are all supportive of these results and do not warrant classification for most of the acute toxicity endpoints under GHS criteria. The majority of the substances are therefore not classified for acute toxicity in accordance with EC regulation 1272/2008. The only exception to this is hexan-1-ol, which finds that the acute dermal data for the test substance are consistent with Acute dermal tox category 4 and Acute oral tox 4 H302/R22, in line with the Annex VI entry.


Justification for selection of acute toxicity – inhalation endpoint
The selected study was conducted according to a protocol similar to an appropriate OECD guideline.

Justification for selection of acute toxicity – dermal endpoint
The selected study was conducted according to a protocol similar to an appropriate OECD guideline.

Justification for classification or non-classification

Acute toxicity tests of the tested substances do not indicate any potential hazard for acute, dermal or inhalation toxicity. Tests on similar substances included in this category are also supportive of these results, which do not warrant classification for any acute toxicity endpoint under GHS criteria. The substance is therefore not classified for acute toxicity in accordance with Regulation No (EC) 1272/2008.