Registration Dossier

Administrative data

Description of key information

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), tetradecan-1-ol and dodecan-1-ol. The most sensitive endpoint for acute oral toxicity, reports an LD50 from studies with both dodecan-1-ol and tetradecan-1-ol of >2000mg/kg in the rat. The most reliable and relevant acute oral toxicity study (Holalagoudar, 2012), however, was conducted using Alchisor TAL 123 and also yielded an LD50 of >2000mg/kg. For acute inhalation toxicity the most sensitive endpoint is from a study with tetradecan-1-ol in rats, in which the LC50 was reported to be >1.5mg/l. In addition the most sensitive endpoint for acute dermal toxicity comes from a dodecan-1-ol study in the rabbit and reported a LD50 1500mg/kg - 2000mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
700 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50

Additional information

Alchisor TAL 123 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), undecan-1-ol and dodecan-1-ol. As defined in the Read-across Justification Document in section 13, data provided for these constituents when considered together is representative of Alchisor TAL 123 and suitable for assessment purposes. Study data for each constituent has been evaluated and considered together. In a conservative approach the most sensitive study result from across the three constituents has been identified and used to address the hazard endpoint in question.

 

Oral

 

9 acute oral toxicity study reports are available in relation to constituents of Alchisor TAL 123 (Klimisch score 1, 2 or 4). This endpoint includes one Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), three undecan-1-ol and four dodecan-1-ol acute studies. Adequate reliable data is available for each constituent category. Therefore using a conservative approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes.

 

The most sensitive study identified across the constituents for acute oral toxicity has been reported in a study with dodecan-1-ol with an LD50determined to be >2000mg/kg. This OECD 401 guideline acute oral limit test gavage study was conducted in SD rats with Kalcol 2098 (dodecan-1-ol). There were no deaths or clinical signs of toxicity (Hempstock 1966). Studies evaluated for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and undecan-1-ol in addition to an unreliable study (Klimisch 4) with Alchisor TAL 123 have reported endpoints that are less sensitive. As a consequence of this study information Alchsior TAL 123 is determined to have an acute oral LD50 >2000mg/kg. Furthermore, the most reliable and relevant acute oral toxicity study (Holalagoudar, 2012) was conducted using Alchisor TAL 123 and also yielded an LD50 >2000 mg/kg.

 

Inhalation

 

5 acute inhalation toxicity study reports are available for constituents of Alchisor TAL 123. This endpoint includes two Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), one decanol, one undecan-1-ol, and one dodecan-1-ol acute studies. Adequate reliable data is available for each constituent. Therefore using a conservative approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes.

 

The most sensitive study identified across the 3 constituents for acute inhalation toxicity has been reported in a study with undecan-1-ol with an LC50determined to be >700mg/m3. This reliable (Klimisch score 2) non-guidelines acute inhalation study was conducted on male SD rats with undecan-1-ol at a concentration of 700mg/m3. The rats were exposed for a 6hr period and subsequently observed for a further 10 days. No deaths occurred during the exposure period or the 10 day observation period. Upon removal from the exposure chamber test animals exhibited roughened fur (Younger Laboratories 1972).

 

Studies evaluated for both Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aomatics (2-25%) and dodecan-1-ol have reported endpoints that are less sensitive. As a consequence of this study information Alchsior TAL 123 is determined to have an acute inhalation LC50>700mg/m3.

 

Dermal

 

8 acute dermal toxicity reports are available for constituents of Alchisor TAL 123. This endpoint includes one Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%), four undecan-1-ol and three dodecan-1-ol acute studies. Adequate reliable data is available for each constituent. Therefore using a conservative approach the dataset is a reliable adequate basis for Alchisor TAL assessment purposes.

 

The most sensitive study identified across the 3 constituents for acute dermal toxicity has been reported in a study with dodecan-1-ol. This semi-occlusive acute dermal toxicity study was conducted with Alfol 12 alcohol (dodecan-1-ol) in NZW rabbits with an exposure time of 24hr. None of the animals survived application at the top dose (2g/kg), whereas there was only one death from a group of four animals at the 1.5g/kg dose level. Consequently the LD50was reported as 1500mg/kg - 2000mg/kg (Scientific Associates Inc 1975).

 

Studies evaluated for both Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and undecan-1-ol have reported endpoints that are less sensitive. As a consequence of this study information Alchsior TAL 123 is determined to have an acute dermal LD50of 1500mg/kg - 2000mg/kg.

Justification for classification or non-classification

Alchisor TAL 123 based on the available acute toxicity information does not present an acute oral toxicity hazard since it is non-classifiable according Regulation (EC) No 1272/2008