Reaction mass of tridecanal and 2-methyldodecanal and pentadecanal and 2-methyltetradecanal

Endpoint summary

Description of key information

No acute toxicity studies with n/i-C13-C15-aldehydes are available, but data from structurally closely related n-undecanal and 3,5,5,-trimethylhexanal are used for read-across. 
The oral and dermal LD50 value were >5000 mg/kg bw in rats (oral) and rabbits (dermal). 
Inhalation exposure is not regarded as being relevant because the very low vapour pressure will only lead to minor air concentrations.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Additional information

No acute toxicity studies with n/i-C13 -C15 -aldehydes are available. However, information from structurally closely related substances (saturated unbranched or branched long chain aldehydes; n-undecanal or n/i-undecanal and 3,5,5,-trimethylhexanal) are used for read-across. N-undecanal is readily metabolised via ß-oxidation like n/i-C13 -C15 -aldehydes, whereas the methyl groups at uneven positions inhibit ß-oxidation and detoxification of 3,5,5-trimethylhexanal may therefore be regarded to represent a worst case.

Oral route

N-Undecanal (purity: not stated) was administered to 5 male and 5 female Sprague-Dawley albino rats by gavage at the limit dose of 5000 mg/kg bw according to testing guideline OECD 401. Following dosing minor clinical signs (as e.g. hunched posture, pilo-erection as well as diarrhoea or ptosis) occurred, but were all reversible within 3 days. During the 14 days observation period no animal died. Subsequent gross pathology revealed congestions of the lungs in three rats, but no other macroscopic changes were seen. The given results lead to a LD50 > 5000 mg test item per kg bw (LD0 = 5000 mg/kg bw; Ruhrchemie AG/Safepharm, 1985).

 

3,5,5 -trimethylhexanal: When fasted rats were exposed to single oral doses of 2000 mg 3,5,5 -trimethylhexanal/kg bw, there were clinical signs of toxicity and increased mortality (1/10 animals died during 14 day observation period). The LD50 was > 2000 mg/kg bw (Hüls AG, 1997). The treatment of fasted rats with single oral doses resulted in clinical signs of toxicity and increased mortality. The LD50 was 5266 mg/kg bw (males/females), 4737 mg/kg bw (females) and 5848 mg/kg bw (males) (Hazleton Laboratories, 1982).

 

Based on the above, the acute oral LD50 of n/i-C13 -C15 -aldehydes in rats is considered to be >5000 mg/kg bw.

  

Inhalation

No valid study was located. The vapour pressure of n/i-C13 -C15 -aldehydes is very low, and therefore the saturation concentration is also low. Inhalation is therefore not considered to represent a relevant exposure route.

 

Dermal route

No deaths occurred in 3 rats that were dermally exposed for 24 hours to 5000 mg n-undecanal/kg bw (Shelanski and Moldova, 1971). This result can be read-across to n/i-C13 -C15 -aldehydes.

Justification for selection of acute toxicity – inhalation endpoint
Only two routes of exposure required. Inhalation route not relevant for this submission substance of low volatility (low vapour pressure (3 hPa) and high boiling point).

Justification for classification or non-classification

According to the criteria set in Regulation (EC) No 1272/2008 no classification for acute toxicity is required as available data from read-across substances indicate that oral and dermal LD50 values are above 5000 mg/kg.