Amines, N-coco alkyltrimethylenedi-, acetates

Endpoint summary

Description of key information

Oral route: Published data report the LD50 of an analogue substance to be > 5 g/kg following oral administration.

Dermal route : The acute dermal toxicity of cocamide DEA was evaluated using albino rabbits. Cocamide DEA were applied to intact and abraded skin for 24 h using occlusive patches. None of the animals died, and the LD50 was >2 g/kg.

Cocamide DEA is a mixture of ethanolamides of coconut acid. The chemistry of the amides is considered to be sufficiently close to the cocamines to be a suitable surrogate for read-across in the absence of any animal test data for the substance under registration.

Other similar cocamide species, such as lauramide DEA, were also tested in this acute dermal toxicity study and also found to be non-toxic

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

not specified

GLP compliance:

not specified

Remarks:

date of studies not specified

Species:

rat

Route of administration:

oral: unspecified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 other: g/kg

Based on:

test mat.

Clinical signs:

other:

Interpretation of results:

GHS criteria not met

Conclusions:

Published data report the LD50 of an analogue substance to be > 5 g/kg following oral administration.

Executive summary:

Results from three studies involving an analogue substance are available. In the first study, an acute oral toxicity test in male and female Sprague-Dawley rats, undiluted cocamide DEA had an LD50 of 12.2 g/kg. In the second study, the acute oral toxicity of cocamide DEA was determined using groups of 3 male and 3 female Wistar rats. Three or more animals per group died with doses of ≥ 6.3 g/kg. In the third study, LD50 of cocamide DEA was reported as > 5 g/kg or 5 mL/kg, which was the highest dose tested.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

See read-across justification attached in Section 13.

Reason / purpose for cross-reference:

read-across source

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Based on:

test mat.

Clinical signs:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Version / remarks:

Assumed from details given in the review. Actual method used was not quoted

GLP compliance:

not specified

Remarks:

No details given in the review article

Test type:

fixed dose procedure

Species:

rabbit

Strain:

other: Albino

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Applied to intact and abraided skin

Duration of exposure:

24 hours

Doses:

2g/kg

No. of animals per sex per dose:

3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other:

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity of cocamide DEA was evaluated using albino rabbits. Cocamide DEA were applied to intact and abraded skin for 24 h using occlusive patches. None of the animals died, and the LD50 was >2 g/kg.
Cocamide DEA is a mixture of ethanolamides of coconut acid. The chemistry of the amides is considered to be sufficiently close to the cocamines to be a suitable surrogate for read-across in the absence of any animal test data for the substance under registration.
Other similar cocamide species, such as lauramide DEA, were also tested in this acute dermal toxicity study and also found to be non-toxic

Reference 2

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Clinical signs:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral route: Results from three studies involving an analogue substance are available. In the first study, an acute oral toxicity test in male and female Sprague-Dawley rats, undiluted cocamide DEA had an LD50 of 12.2 g/kg. In the second study, the acute oral toxicity of cocamide DEA was determined using groups of 3 male and 3 female Wistar rats. Three or more animals per group died with doses of ≥ 6.3 g/kg. In the third study, LD50 of cocamide DEA was reported as > 5 g/kg or 5 mL/kg, which was the highest dose tested.

Inhalation route: Investigation of acute toxicity via the inhalation route is not required because the substance is a solid with predicted high onset boiling point and low predicted vapour pressure. It is therefore expected that inhalation exposure from identified uses performed under industrial conditions will be negligible.

Dermal route: The registered substance has been shown to be irritating to skin and, in the interests of animal welfare, investigation of systemic toxicity via the dermal route is contraindicated.

Justification for classification or non-classification

An analogue substance exhibits low acute toxicity via the oral route (LD50 > 5g/kg). Based on these data, classification of the target substance for acute toxicity is not required under the terms of Regulation (EC) No 1272/2008.