CONTAINS CONFIDENTIAL BUSINESS INFORMATION

The following is a summary of the hazard classification of the notified substance,

Endpoint US/OSHA GHS

Skin irritation Skin irritant Category 2

Eye irritation Eye irritant Category 2A

Respiratory irritation Mild respiratory irritant Not classified

Aquatic toxicity Toxic to aquatic organisms and may cause long 

lasting effects to aquatic life Chronic/acute Cat. 2

I. Hazard Assessment

The borated ester alkyl amine category consists of fatty alkanolamides that are further reacted with 

boric acid and glycerol to form borated esters. The preliminary hazard classification of the notified 

substance, 

is based on the existing hazard evaluation of an alkanolamide purchased 

component, which is a starting material of 

the notified substance. The borated esters that are manufactured by the notifier (e.g.

 are 

also included to determine whether the borate ester functional group will contribute any additional 

hazards. Further, an evaluation of boric acid has been included as borate esters can hydrolyze with 

water or with acidic solution releasing boric acid solution, although the intended use of this product is 

exclusively in finished oils contained in closed systems (engines), effectively eliminating the chances for 

water contact, and thus hydrolysis. 

The fatty alkanolamides are an HPV chemical category, which contains both an industry toxicology 

assessment/evaluation and EPA hazard characterization; 

is a member of this category. Another material intentionally added to make the notified 

substance is and the formalized spec for the notified substance 

identifies <1% residual DEA in the final product, which has also been included in the hazard evaluation. 

Following is a breakdown of the contributions from the different functionalities found in the notified 

substance: 

The analog alkanolamide, is classified as 

follows:

Endpoint US/OSHA GHS

Skin irritation Skin irritant Category 2

Eye irritation Eye irritant Category 2A

Respiratory irritation Mild respiratory irritant Not classified

Aquatic toxicity Toxic to aquatic organisms and may cause long 

lasting effects to aquatic life Chronic/acute Cat. 2

There was uncertainty with whether borating the alkanolamide material will alter the toxicological 

properties of the final notified substance. The best read-across substances available to understand this

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]

[ ]
CONTAINS CONFIDENTIAL BUSINESS INFORMATION

potential toxicity of adding a borate ester functional group are the borated monoglycerols, including 

. The hazard classification of the borated esters class is as follows:

Endpoint US/OSHA GHS

Skin irritation Skin irritant Category 2

Respiratory irritation Mild respiratory irritant Not classified

Aquatic toxicity May cause long lasting effects to aquatic life Chronic Cat. 4

Based on read across from borating the alkanolamide is not expected to directly 

alter the toxciologoy of the notified substance. Release of boric acid solution via hydrolyzation of the 

borate esters with water or with acidic solution can occur, but based on its intended use strictly in a 

closed system, this scenario is not expected to occur. Nevertheless, hazard classification of boric acid 

should still be considered to fully evaluate the notified substance. The maximum amount of boric acid 

expected to be released from the borate esters in the event of hydrolysis of the notified substance is 

between 10-15% boric acid, with the boron content between 1.75-2.63%. Boric acid is classified as toxic 

for reproduction GHS category 1B at concentrations greater than or equal to 5.5%. Should the notified 

substance hydrolyze and the maximum amount of boric acid released exceed this specific concentration 

limit, it would be classified as a reproductive hazard, see table below. 

Boric acid is classified as follows:

Endpoint US/OSHA GHS

Reproductive toxicity May impair fertility. May cause harm to unborn child. Repro. Cat. 1B

Other contributing hazards include from residual (<1%):

Endpoint US/OSHA GHS

Target organ toxicity 

(liver, blood, kidney)

May cause damage to the specified organs Category 2

Additionally, a Toxicity to Activated Sludge in a Respiration Inhibition range-finding test conducted on 

the notified substance showed a statistically significant toxic effect at the test concentration of 1000 

mg/L and the pH of the test item dispersions were measured to be as follows:

 

10 mg/L pH 7.3

100 mg/L pH 7.1

1000 mg/L R1 pH 7.8

1000 mg/L R2 pH 7.8

1000 mg/L R3 pH 7.6

 

The results obtained are shown below:

 

Test Concentration (mg/L) % Inhibition

[ [ ] [ ] [ ] [ ]
CONTAINS CONFIDENTIAL BUSINESS INFORMATION

10 0

100 13

1000 R1 65

1000 R2 63

1000 R3 67

 

Based on these results the EC50 value for the notified substance is between 100 and 1000 mg/L.

II. Read Across Summary and Justification

The notified substance is similar in structure to several analog substances and so is expected to have 

similar toxicology. Following is a table summarizing the relevent materials used in this evaluation. 

The notified substance and read across materials used to evaluate it: 

Chemical Structure

NOTIFIED SUBSTANCE

ANALOG AND STARTING MATERIAL

ANALOG

RESIDUAL IMPURITY

Boric Acid

CASRN 10043-35-3, 11113-50-1 

POTENTIAL HYDROLYSIS PRODUCT

[ ]

[ ] [ ]

[ ] [ ]

[ ]

[ ]

[ ]

[ ]