Decyldimethylamine

Endpoint summary

Description of key information

Reliable data from several guideline studies on acute toxicity after oral application are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18-DMA, and C18-DMA. These data reveal low acute oral toxicity of the DMAs of this category: LD50 values for all investigated test items in rats are between 1015 mg/kg bw (C16-DMA) and >2000 mg/kg bw (C10-DMA, C12-14-DMA, C18-DMA) which is the upper limit for classification. No tendency related to increasing carbon chain length is observed.

No data on acute toxicity after inhalation and dermal exposure are available.

As key value the most conservative value for the category members is selected.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.

GLP compliance:

yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

698 mg/kg bw

Based on:

other: Read-across from C16-DMA; value converted based on MW

Remarks on result:

other: Original data for the source: 1015 mg/kg bw

Executive summary:

The study used as source investigated the acute oral toxicity of C16-DMA. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 015 mg/kg bw

Quality of whole database:

good

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Thirteen acute oral toxicity studies in rats (reliability 1 and 2) are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18-DMA and C18-DMA. These studies were performed according or similar to OECD guideline 401 except for one study for C12-18-DMA which was performed similar to OECD TG 425.

Across the available studies the selected application dose levels are in the range of 500-2000 mg/kg bw (in one study for C12-DMA 5000 mg/kg bw were used as the highest concentration) and the treatment related effects are comparable: common clinical signs such as hunched posture, piloerection, lethargy etc. were observed. The animals died mostly within a few days after application. Surviving animals did not show any effect upon necropsy at the end of the observation period. The females seemed to be more susceptible. A clear effect correlation to alkyl chain length could not be established.

Out of these 13 results relevant for classification of test substances, seven results are indicative of LD50 slightly higher than 2000 mg/kg bw and six results are indicative of LD50 values between 1000 and 2000 mg/kg bw. No tendency related to increasing carbon chain length is observed. In a conservative approach the whole category is classified in category 4 for acute oral toxicity according to Regulation (EC) No 1272/2008. 

Since the substances of the DMA category are corrosive to skin, no data on dermal or inhalative toxicity are required.

Justification for classification or non-classification

Based on the LD50 values reported for some acute toxicity studies with DMA category members the substances in the DMA category are classified for Acute Tox. 4 (H303) according to Regulation (EC) No 1272/2008.

Furthermore, DMA category members do not have to be classified for specific target organ toxicity – single exposure according to Regulation (EC) No 1272/2008, as no specific toxic effects were observed after acute oral exposure.