3,7,11,15-tetramethylhexadecane-1,2,3-triol

Endpoint summary

Description of key information

The skin irritation potential of the test substance was assessed according to OECD Test Guideline 404 and EU Method B.4. The mean value for erythema was ≥2.3 in all three rabbits and therefore the substance is classified as a skin irritant (Category 2).

The test substance was assessed for eye irritation potential according to OECD Test Guideline 405 and EU Method B.5. The test substance caused short-lasting corneal opacity with conjunctival reactions and therefore the substance is classified as an eye irritant (Category 2).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The skin irritation potential of the test substance was assessed according to OECD Test Guideline 404 and EU method B.4 using a single topical application of 0.5 mL of the test substance to the intact skin of three rabbits for four hours under semi-occlusive dressing.

The average score (24 to 72 hours) for irritation was calculated to be 2.9 for erythema and 1.3 for oedema. The skin findings were not reversible in all animals within 14 days (study termination). Erythema and oedema were observed extending beyond the area of exposure.

The mean value for erythema was ≥2.3 in all three rabbits.

Eye irritation

The test substance was assessed for eye irritation potential according to OECD Test Guideline 405 and EU Method B.5. A single application of the neat test sample into the conjunctival sac of the rabbit eye caused short-lasting corneal opacity with conjunctival reactions which was reversed within two weeks. No staining of the cornea and sclera of the treated eyes by pigment or coloring of the test article were observed in all animals during the entire study period after test article application. Generally severe to slight corneal opacity was observed at (100%) in the left eye of the animals between 1 hour and 72 hours of it returned to generally slight diffuse corneal opacity between 24 and 72 hours after test article application.

Justification for classification or non-classification

Skin corrosion / irritation

Skin corrosion is defined as the production of irreversible damage to the skin following application of the test substance. Skin irritation is the production of reversible damage to the skin following application of the test substance. Substances can be allocated to one of two categories based on corrosive effects on the skin (Category 1) and irritating to the skin (Category 2) according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

 

During in vivo testing, substances are classified as Category 2 irritants where a mean value of ≥2.3 is observed for erythema or for edema in at least two of the three animals tested from observations at 24, 48 and 72 hours after patch removal. If reactions are delayed, grades on three consecutive days after the onset of skin reactions also result in classification. Substances may be classified for skin irritation if inflammation persists to the end of the observation period in at least two animals.

The test substance was assessed for skin irritation potential and all three animals tested had scores for erythema≥2.3. The test substance is therefore classified as a skin irritant (Category 2).

 

Eye irritation

Serious eye damage is defined as the production of tissue damage in the eye, or serious physical decay or vision following application of the test substance to the anterior surface of the eye which is not fully reversible. Eye irritation means the production of changes in the eye following application of the test substance which is fully reversible. Substances can be allocated to one of two categories based on irreversible effects on the eye (Category 1) and irritating to the eye (Category 2) according to the Globally Harmonized Classification System and Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

 

During in vivo testing, substances may be classified as irritating to eyes, if a corneal opacity score of ≥1 and / or an iritis score≥1 and / or conjunctival redness≥2 and or conjunctival edema (chemosis)≥2 in at least two of the three animals tested, calculated as the mean scores following grading at 24, 48 and 72 hours.

The test substance was assessed for eye irritation potential. Two of the three animals tested had a corneal opacity score ≥1. The test substance is therefore classified as an eye irritant (Category 2).