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Administrative data

Description of key information

Alchisor TAL 145 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
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1 500 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50

Additional information

Alchisor TAL 145 can be characterised according to three constituents: Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%), dodecan-1-ol and tetradecan-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 145 and suitable for assessment purposes. Study data for each constituent has been evaluated and considered together. The most reliable and relevant acute oral toxicity study (Holalagoudar, 2012), however, was conducted using Alchisor TAL 123 and yielded an LD50 of >2000mg/kg.

 

Oral

 

As detailed in Table 1 below 10 acute oral toxicity study reports are available for constituents of Alchisor TAL 145. Adequate reliable data is available for each constituent. Therefore, using our protective approach the dataset is a reliable adequate basis for Alchisor TAL 145 assessment purposes.

 

Table 1: Acute Oral Key/Supporting Studies for Constituents of Alchisor TAL 145

 

 

Constituents of Alchisor TAL 145

 

Reference

Hydrocarbons

C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Dodecan-1-ol

Tetradecan-1-ol

Hempstock 1996a

 

 

Key

Scientific Associates 1977

 

 

Supporting

Opdyke 1975

 

 

Supporting

Cosmetic Ingredient Review

 

 

Supporting

IUCLID 2000

 

 

Supporting

Exxon 1977

Key

 

 

Hempstock 1996b

 

Key

 

Scientific Associates 1965

 

Supporting

 

Henkel 1981

 

Supporting

 

Lington 1994

 

Supporting

 

 

The most sensitive study result identified across the constituents for acute oral toxicity has been reported in studies with dodecan-1-ol and tetradecan-1-ol. Both studies reported an LD50 of >2000mg/kg. In the first of the two studies, Kalcol 2098 (dodecan-1-ol) was assessed for acute oral toxicity in an OECD 401 guideline, GLP compliant study with SD rats. There were no deaths or clinical signs of toxicity and the LD50 was consequently determined to be >2000mg/kg (Hempstock 1996a). In the second study Kalcol 4098 (tetradecan-1-ol) was assessed for acute oral toxicity in an OECD 401 guideline, GLP compliant study with SD rats. There were no deaths and no signs of systemic toxicity during the study. The LD50 was consequently determined to be >2000mg/kg (Hempstock 1996b).

 

Studies evaluated for Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%) have reported endpoints that are less sensitive that the LD50 >2000mg/kg reported in the two acute oral studies documented above.

The most relevant and reliable study, however, is an OECD 423 acute toxicity, oral gavage study with Alchisor TAL 123 (Holalagoudar, 2012). The study, which was conducted using female Wistar rats, resulted in no animal deaths at a dose of 2000 mg/kg. Thus the median lethal dose of Alchisor TAL 123 after a single oral administration to female rats, observed over a period of 14 days, is LD50 > 2000 mg/kg. At a dose of 2000 mg/kg the study authors observed slight piloerection in all animals and other signs of toxicity in three of the six animals (slightly reduced spontaneous activity, half eyelid-closure).

In light of the study results presented here, Alchisor TAL 145 is determined to have an acute oral LD50 >2000mg/kg.

 

Inhalation

 

As detailed in Table 2 below, 8 acute inhalation toxicity study reports are available for constituent/constituent categories of Alchisor TAL 145. Adequate reliable data is available for each constituent/constituent category. Therefore, using our protective approach the dataset is a reliable adequate basis for Alchisor TAL 145 assessment purposes.

 

Table 2: Acute Inhalation Key/Supporting Studies for Constituents of Alchisor TAL 145

 

 

Constituents of Alchisor TAL 145

 

Reference

Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%)

Dodecan-1-ol

Tetradecan-1-ol

Scientific Associates 1977

 

 

Key

Smyth 1969

 

 

Supporting

Cosmetic Ingredient Review 1988

 

 

Supporting

Hobert 1990

Supporting

 

 

Coombs 1977

Key

 

 

Amouruso 2008 & Carpenter 1975

Key (read across)

 

 

Scientific Associates 1977

 

Key (read across)

 

Clayton & Clayton 1994

 

Supporting

 

 

The most sensitive reliable study identified across the 3 constituent/constituent categories for acute inhalation toxicity has been reported in a study with tetradecan-1-ol. In this reliable (Klimisch 2) study COX-SD rats were exposed to 1.5 mg/l test atmospheres of tetradecan-1-ol for 1 hour. No deaths were reported and there were no clinical signs of toxicity present at any point during the study. In this study the LC50 was determined to be >1.5mg/l (Scientific Associates Inc.1977[o1] ).

 

Reliable studies evaluated for both Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and dodecan-1-ol have reported endpoints that are less sensitive. As a consequence of this study information Alchisor TAL 145 is determined to have an acute inhalation LC50 >1.5mg/l.

 

Dermal

 

As detailed in Table 3 below, 7 acute dermal studies are available for constituent/constituent categories of Alchisor TAL 145. Adequate reliable data is available for each constituent/constituent category. Therefore, using our protective approach the dataset is a reliable adequate basis for Alchisor TAL 145 assessment purposes.

 

Table 3: Acute Dermal Key/Supporting Studies for Constituents of Alchisor TAL 145

 

 

Constituents of Alchisor TAL 145

 

Reference

Hydrocarbons C11-C14, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%)

Dodecan-1-ol

Tetradecan-1-ol

Scientific Associates 1977a

 

 

Key

Smyth 1969

 

 

Supporting

Opdyke 1975

 

 

Supporting

Coombs 1977

Key

 

 

Scientific Associates 1975

 

Key

 

Scientific Associates 1977b

 

Supporting

 

Lington & Bevan 1994

 

Supporting

 

 

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 LD50 was 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 tetradecan-1-ol have reported endpoints that are less sensitive. As a consequence of this study information Alchisor TAL 145 is determined to have an acute dermal LD50 of 1500mg/kg - 2000mg/kg.

Justification for classification or non-classification

Alchisor TAL 145 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