Hexadecyl acetate

Endpoint summary

Description of key information

No toxicity reported following oral or dermal administration of the test item (LD50 oral 40.0 mL/kg using a preparation declared to contain 90 % of test item; LD50 dermal > 5000 mg/kg).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 February 1973 to 27 February 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not applicable

Principles of method if other than guideline:

Preparation containing 90 % test item administered to albino rats (five groups of two animals) with 14 day observation period.

GLP compliance:

no

Remarks:

investigation took place before the introduction of GLP

Test type:

other: similar to acute toxic class method

Limit test:

no

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Five groups of albino rats (one male and one female per group) were set aside and observed for a period of one week to assure normalcy.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Animals were starved for 24 hours.
- Doses were determined for each animal and administered directly into the stomach by means of a stomach tube.
- Animals were allowed food and water ad libitum during a fourteen day observation period.

Doses:

2.5, 5.0, 10.0, 20.0 and 40.0 mL/kg

No. of animals per sex per dose:

One male and one female per dose group

Control animals:

no

Sex:

male/female

Dose descriptor:

other: no toxicity reported following oral administration

Mortality:

No mortality

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Other findings:

Not reported

Dose Level mL/kg	Number of rats dosed	Day														Mortality after 14 days
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
2.5	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
5.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
10.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
20.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
40.0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was demonstrated to have an acute oral oral LD50 greater than 40.0 mL/kg in the rat.

Executive summary:

METHOD

A preparation declared to contain 90 % of test item was administered in a single dose by gavage to five groups of Sherman-Wistar rats consisting of one male and one female. Mortality after a fourteen day observation period was reported.

RESULTS

No mortality was observed in rats dosed with 2.5, 5.0, 10.0, 20.0 or 40.0 mL/kg of the test material.

CONCLUSION

The test material was demonstrated to have an acute oral LD50 greater than 40.0 mL/kg in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Oral

A preparation declared to contain 90 % of test item was administered in a single dose by gavage to five groups of Sherman-Wistar rats consisting of one male and one female. Mortality after a fourteen day observation period was reported.

 

No mortality was observed in rats dosed with 2.5, 5.0, 10.0, 20.0 or 40.0 mL/kg of the test material and the acute oral LD50 was determined to be 40.0 mL/kg in the rat.

Inhalation

According to REACH Annex XIII Section 8.5 information on acute toxicity will be provided for at least one other route in addition to the oral route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. The substance is a waxy solid with a vapour pressure of 4.8E-03 Pa at 25°C and is used exclusively as a cosmetic ingredient. Based on evaluation of the life cycle of the substance it is concluded that inhalation exposure will be low and that the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is, therefore, not required.

Dermal

The final report of the Cosmetic Ingredient Review Expert Panel on the safety assessment of methyl acetate (Heldreth et al, International Journal of Toxicology, Vol 31, No 4, Suppl 07.2012) cites an unpublished report submitted to the Research Institute for Fragrance Materials Inc by Moreno in 1980 and accepts the quoted dermal LD50 of > 5000 mg/kg in rats and rabbits as evidence that the test item does not cause systemic toxicity via the dermal route. This conclusion is underpinned by a study (see Section 7.10.5) in which 50 % test material in petrolatum (equivalent to 45 % of the test item described in this dossier) did not elicit any response in 50 out of 53 human volunteers when applied to the same test site for 24 hours on four consecutive days for a period of three weeks. Furthermore, the test item is used exclusively as a cosmetic ingredient for which animal testing is discouraged, and it is handled at industrial sites where stringent risk mitigation measures are routinely incorporated into operational procedures.As a result, and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, it is considered inappropriate to carry out further investigations involving vertebrate animals.

Justification for selection of acute toxicity – oral endpoint
Meets generally accepted scientific standards, well documented and acceptable for assessment.

Justification for classification or non-classification

No adverse effect has been reported during investigation of acute toxicity via the oral route in the rat and via the dermal route in rats and rabbits. As such, classification in accordance with Regulation (EC) No 1272/2008 is not required.